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Completed

NCT Number: NCT03387813

Hemodynamic-GUIDEd Management of Heart Failure

The GUIDE-HF IDE clinical trial is intended to demonstrate the effectiveness of the CardioMEMS™ HF System in an expanded patient population including heart failure (HF) patients outside of the present indication, but at risk for future HF events or mortality.

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases Heart Failure NYHA Class II Heart Failure NYHA Class III Heart Failure NYHA Class IV Heart Failure With Normal Ejection Fraction Heart Failure With Reduced Ejection Fraction Heart Failure, Diastolic Heart Failure, Systolic Heart Failure; With Decompensation Heart Failure，Congestive

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Foothills Medical Centre, Calgary, Alberta, Canada

Loading trial locations.

About this study

The GUIDE-HF IDE clinical trial is intended to demonstrate the effectiveness of the CardioMEMS™ HF System in an expanded patient population including HF patients outside of the present indication, but at risk for future HF events or mortality.

The trial includes patients with New York Heart Association (NYHA) Class II, III, or IV HF who have an elevated N-terminal pro-Brain Natriuretic Peptide (NT-proBNP) (or an elevated Brain Natriuretic Peptide (BNP)) and/or a prior HF hospitalization (HFH).

The GUIDE-HF IDE trial will include approximately 3600 subjects at approximately 140 North American sites and consists of two arms: a Randomized Arm and a Single Arm.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis and treatment for heart failure (HF) (regardless of left ventricular ejection fraction (LVEF)) for > 90 days prior to the date of consent:

a. Subjects should be on stable, optimally titrated medical therapy for at least 30 days, as recommended according to current American Heart Association (AHA)/American College of Cardiology (ACC) guidelines as standard-of-care for HF therapy in the United States, with any intolerance documented.

  • GUIDE-HF Randomized Arm Only: NYHA Class II, III or IV HF symptoms documented within 30 days prior to consent.
  • GUIDE-HF Single Arm Only: NYHA Class III HF symptoms documented within 30 days prior to consent.
  • HF hospitalization (HFH) within 12 months prior to consent and/or elevated N-terminal pro-Brain Natriuretic Peptide (NT-proBNP) (or Brain Natriuretic Peptide (BNP)) within 30 days prior to consent defined as:
  • Subjects with LVEF ≤ 40%: NT-proBNP ≥ 1000 pg/mL (or BNP ≥ 250 pg/mL).
  • Subjects with LVEF > 40%: NT-proBNP ≥ 700 pg/mL (or BNP ≥ 175 pg/mL).
  • Thresholds for NT-proBNP and BNP (for both LVEF ≤ 40% and LVEF > 40%) will be corrected for body mass index (BMI) using a 4% reduction per BMI unit over 25 kg/m2
  • ≥ 18 years of age
  • Chest circumference of < 65 inches, if BMI is > 35 kg/m2
  • Written informed consent obtained from subject
  • Willing and able to upload pulmonary artery (PA) pressure information and comply with the follow-up requirements

Exclusion criteria

  • Intolerance to all neuro-hormonal antagonists (i.e., intolerance to angiotensin converting enzyme-inhibitors (ACE-I), angiotensin receptor blockers (ARB), angiotensin-neprilysin inhibitors (ARNi), hydralazine/isosorbide dinitrate and beta-blockers)
  • ACC/AHA Stage D refractory HF (including having received or currently receiving pharmacologic circulatory support with inotropes)
  • Received or are likely to receive an advanced therapy (e.g., mechanical circulatory support or cardiac transplant) in the next 12 months
  • NYHA Class IV HF patients with:
  • Continuous or chronic use of scheduled intermittent inotropic therapy for HF and an INTERMACS level of ≤ 4, OR
  • Persistence of fluid overload with maximum (or dose equivalent) diuretic intervention
  • Glomerular Filtration Rate (eGFR) < 25 mL/min and non-responsive to diuretic therapy, or receiving chronic dialysis
  • Inability to tolerate or receive dual antiplatelet therapy or anticoagulation therapy for one month post-implantation
  • Significant congenital heart disease that has not been repaired and would prevent implantation of the CardioMEMS™ PA Sensor
  • Implanted with mechanical right heart valve(s)
  • Unrepaired severe valvular disease
  • Pregnant or planning to become pregnant in the next 12 months
  • An active, ongoing infection, defined as being febrile, an elevated white blood cell count, on intravenous antibiotics, and/or positive cultures (blood, sputum or urine).
  • History of current or recurrent (≥ 2 episodes within 5 years prior to consent) pulmonary emboli and/or deep vein thrombosis
  • Major cardiovascular event (e.g., unstable angina, myocardial infarction, percutaneous coronary intervention, open heart surgery, or stroke, etc.) within 90 days prior to consent
  • Implanted with Cardiac Resynchronization Therapy (CRT)-Pacemaker (CRT-P) or CRT-Defibrillator (CRT-D) for less than 90 days prior to consent
  • Enrollment into another trial with an active treatment arm
  • Anticipated life expectancy of < 12 months
  • Any condition that, in the opinion of the Investigator, would not allow for utilization of the CardioMEMS™ HF System to manage the subject using information gained from hemodynamic measurements to adjust medications, including the presence of unexpectedly severe pulmonary hypertension (e.g., trans-pulmonary gradient >15) at implant right heart catheterization (RHC), a history of non-compliance, or any condition that would preclude CardioMEMS™ PA Sensor implantation

Treatment and study plan

CardioMEMS™ HF System

Device

The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.

Other names: CardioMEMS, CardioMEMS PA Sensor, CardioMEMS HF System

Primary outcomes

  1. (Randomized Arm) Composite Outcome of (1) HFHs, (2) Intravenous Diuretic Visits, and (3) All-cause Mortality

    Time frame: 12 months post-implantation (395 days after implant date)

    The composite of:

    • The number of recurrent heart failure hospitalizations (HFHs)
    • The number of heart failure (HF) emergency department/hospital outpatient observation visits for intravenous diuretic therapy (ED/OP)
    • The number of deaths of any cause

    added together with equal weighting into a total number of events

  2. (Randomized Arm) Composite Outcome of (1) HFHs, (2) Intravenous Diuretic Visits, and (3) All-cause Mortality [Follow-up Based COVID-19 Sensitivity Analysis]

    Time frame: The COVID-19 pandemic occurred during follow-up after enrollment of all subjects. Events were analyzed through March 13, 2020 for pre-COVID-19 (median follow-up: 8.4 months) and after March 13, 2020 for during COVID-19 (median follow-up: 5.2 months).

    The composite of:

    • The number of recurrent heart failure hospitalizations (HFHs)
    • The number of heart failure (HF) emergency department/hospital outpatient observation visits for intravenous diuretic therapy (ED/OP)
    • The number of deaths of any cause

    added together with equal weighting into a total number of events.

  3. (Randomized Arm) Composite Outcome of (1) HFHs, (2) Intravenous Diuretic Visits, and (3) All-cause Mortality [Subject Based COVID-19 Sensitivity Analysis]

    Time frame: 12 Months Post Implantation

    The composite of:

    • The number of recurrent heart failure hospitalizations (HFHs)
    • The number of heart failure (HF) emergency department/hospital outpatient observation visits for intravenous diuretic therapy (ED/OP)
    • The number of deaths of any cause

    added together with equal weighting into a total number of events.

  4. (Randomized Arm) Composite Outcome of (1) HFHs, (2) Intravenous Diuretic Visits, and (3) All-cause Mortality [Event Based COVID-19 Sensitivity Analysis]

    Time frame: 12 Months Post-Implantation

    The composite of:

    • The number of recurrent heart failure hospitalizations (HFHs)
    • The number of heart failure (HF) emergency department/hospital outpatient observation visits for intravenous diuretic therapy (ED/OP)
    • The number of deaths of any cause

    added together with equal weighting into a total number of events.

  5. (Single Arm) Composite Outcome of (1) HFHs, (2) Intravenous Diuretic Visits, and (3) All-cause Mortality

    Time frame: 12 months post-implantation (395 days after implant date)

    The composite outcome of:

    • The number of recurrent heart failure hospitalizations (HFHs)
    • The number of emergency department/hospital outpatient observation visits for intravenous diuretic therapy
    • The number of deaths of any cause

    added together with equal weighting into a total number of events

  6. (Single Arm) Composite Outcome of (1) HFHs, (2) Intravenous Diuretic Visits, and (3) All-cause Mortality [Follow-up Based COVID-19 Sensitivity Analysis]

    Time frame: Events were analyzed through March 13, 2020 for pre-COVID-19 analysis (median follow-up: 5.4 months) and from March 13, 2020 through the end of subject's follow-up for during COVID-19 analysis (median follow-up: 11.2 months).

    The composite outcome of:

    • The number of recurrent heart failure hospitalizations (HFHs)
    • The number of emergency department/hospital outpatient observation visits for intravenous diuretic therapy
    • The number of deaths of any cause

    added together with equal weighting into a total number of events

  7. (Single Arm) Composite Outcome of (1) HFHs, (2) Intravenous Diuretic Visits, and (3) All-cause Mortality [Subject Based COVID-19 Sensitivity Analysis]

    Time frame: 12 Months Post Implantation

    The composite outcome of:

    • The number of recurrent heart failure hospitalizations (HFHs)
    • The number of emergency department/hospital outpatient observation visits for intravenous diuretic therapy
    • The number of deaths of any cause

    added together with equal weighting into a total number of events

  8. (Single Arm) Composite Outcome of (1) HFHs, (2) Intravenous Diuretic Visits, and (3) All-cause Mortality [Event Based COVID-19 Sensitivity Analysis]

    Time frame: 12 Months Post Implantation

    The composite outcome of:

    • The number of recurrent heart failure hospitalizations (HFHs)
    • The number of emergency department/hospital outpatient observation visits for intravenous diuretic therapy
    • The number of deaths of any cause

    added together with equal weighting into a total number of events

Secondary outcomes

  1. (Randomized Arm) Composite Outcome of (1) HFHs and (2) Intravenous Diuretic Visits

    Time frame: 12 months post-implantation

    The composite outcome of:

    • The number of recurrent heart failure hospitalizations (HFHs)
    • The number of emergency department/hospital outpatient observation visits (ED/OP) for intravenous diuretic therapy

    added together with equal weighting into a total number of events

  2. (Randomized Arm) Composite Outcome of (1) HFHs and (2) Intravenous Diuretic Visits [Follow-up Based COVID-19 Sensitivity Analysis)

    Time frame: The COVID-19 pandemic occurred during follow-up after enrollment of all subjects. Events were analyzed through March 13, 2020 for pre-COVID-19 (median follow-up: 8.4 months) and after March 13, 2020 for during COVID-19 (median follow-up: 5.2 months).

    The composite outcome of:

    • The number of recurrent heart failure hospitalizations (HFHs)
    • The number of emergency department/hospital outpatient observation visits (ED/OP) for intravenous diuretic therapy

    added together with equal weighting into a total number of events

  3. (Randomized Arm) Composite Outcome of (1) HFHs and (2) Intravenous Diuretic Visits [Subject Based COVID-19 Sensitivity Analysis)

    Time frame: 12 Months Post Implantation

    The composite outcome of:

    • The number of recurrent heart failure hospitalizations (HFHs)
    • The number of emergency department/hospital outpatient observation visits (ED/OP) for intravenous diuretic therapy

    added together with equal weighting into a total number of events

  4. (Randomized Arm) Composite Outcome of (1) HFHs and (2) Intravenous Diuretic Visits [Event Based COVID-19 Sensitivity Analysis)

    Time frame: 12 Months Post Implantation

    The composite outcome of:

    • The number of recurrent heart failure hospitalizations (HFHs)
    • The number of emergency department/hospital outpatient observation visits (ED/OP) for intravenous diuretic therapy

    added together with equal weighting into a total number of events

  5. (Randomized Arm) HFHs

    Time frame: 12 months post-implantation

    The number of recurrent HFHs

  6. (Randomized Arm) HFHs [Follow-up Based COVID-19 Sensitivity Analysis]

    Time frame: The COVID-19 pandemic occurred during follow-up after enrollment of all subjects. Events were analyzed through March 13, 2020 for pre-COVID-19 (median follow-up: 8.4 months) and after March 13, 2020 for during COVID-19 (median follow-up: 5.2 months).

    The number of recurrent HFHs

  7. (Randomized Arm) HFHs [Subject Based COVID-19 Sensitivity Analysis]

    Time frame: 12 Months Post-Implantation

    The number of recurrent HFHs

  8. (Randomized Arm) HFHs [Event Based COVID-19 Sensitivity Analysis]

    Time frame: 12 Months Post Implantation

    The number of recurrent HFHs

  9. (Randomized Arm) Intravenous Diuretic Visits

    Time frame: 12 months post-implantation

    The number of emergency department/hospital outpatient observation visits for intravenous diuretic therapy

  10. (Randomized Arm) Intravenous Diuretic Visits [Follow-up Based COVID-19 Sensitivity Analysis]

    Time frame: The COVID-19 pandemic occurred during follow-up after enrollment of all subjects. Events were analyzed through March 13, 2020 for pre-COVID-19 (median follow-up: 8.4 months) and after March 13, 2020 for during COVID-19 (median follow-up: 5.2 months).

    The number of emergency department/hospital outpatient observation visits for intravenous diuretic therapy

  11. (Randomized Arm) Intravenous Diuretic Visits [Subject Based COVID-19 Sensitivity Analysis]

    Time frame: 12 Months Post Implantation

    The number of emergency department/hospital outpatient observation visits for intravenous diuretic therapy

  12. (Randomized Arm) Intravenous Diuretic Visits [Event Based COVID-19 Sensitivity Analysis]

    Time frame: 12 Months Post-Implantation

    The number of emergency department/hospital outpatient observation visits for intravenous diuretic therapy

  13. (Randomized Arm) All-cause Mortality

    Time frame: 12 months post-implantation

    The number of deaths of any cause

  14. (Randomized Arm) All-cause Mortality [Follow-up Based COVID-19 Sensitivity Analysis]

    Time frame: The COVID-19 pandemic occurred during follow-up after enrollment of all subjects. Events were analyzed through March 13, 2020 for pre-COVID-19 (median follow-up: 8.4 months) and after March 13, 2020 for during COVID-19 (median follow-up: 5.2 months).

    The number of deaths of any cause

  15. (Randomized Arm) All-cause Mortality [Subject Based COVID-19 Sensitivity Analysis]

    Time frame: 12 Months Post-Implantation

    The number of deaths of any cause

  16. (Randomized Arm) All-cause Mortality [Event Based COVID-19 Sensitivity Analysis]

    Time frame: 12 Months Post-Implantation

    The number of deaths of any cause

  17. (Randomized Arm) KCCQ-12

    Time frame: Baseline, 6, and 12 months post-implantation

    Health status as assessed by the Kansas City Cardiomyopathy Questionnaire (KCCQ-12)

    The Kansas City Cardiomyopathy Questionnaire (KCCQ-12) is a validated health-related quality of life measure for heart failure and was qualified by the FDA as a medical device development tool in 2017. The KCCQ-12 quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life over a scale from 0 to 100. An overall summary score (OSS) is derived by averaging scores from each domain, with a higher score reflecting a better health status.

    Change from baseline KCCQ-12 scores were evaluated at 6 and 12-month visits.

  18. (Randomized Arm) KCCQ-12 (Subject Based COVID-19 Sensitivity Analysis)

    Time frame: Baseline, 6, and 12 months post-implantation

    Health status as assessed by the Kansas City Cardiomyopathy Questionnaire (KCCQ-12) The Kansas City Cardiomyopathy Questionnaire (KCCQ-12) is a validated health-related quality of life measure for heart failure and was qualified by the FDA as a medical device development tool in 2017. The KCCQ-12 quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life over a scale from 0 to 100. An overall summary score (OSS) is derived by averaging scores from each domain, with a higher score reflecting a better health status.

    Descriptive statistics of KCCQ-12 scores at baseline, 6 and 12-month visits were reported.

  19. (Randomized Arm) EQ-5D-5L

    Time frame: Baseline, 6, and 12 months post-implantation

    Health status as assessed by the EuroQol 5-Dimension, 5-Level (EQ-5D-5L) Questionnaire

    The EQ-5D-5L Questionnaire is a standardized measure of health status that consists of a descriptive system and a visual analog score (VAS). The VAS records the subject's self-rated health status which ranges from a score of 0 (worst health you can imagine) to 100 (best health you can imagine). A higher VAS score represents a better quality of life.

  20. (Randomized Arm) EQ-5D-5L (Subject Based COVID-19 Sensitivity Analysis)

    Time frame: Baseline, 6, and 12 months post-implantation

    Health status as assessed by the EuroQol 5-Dimension, 5-Level (EQ-5D-5L) Questionnaire The EQ-5D-5L Questionnaire is a standardized measure of health status that consists of a descriptive system and a visual analog score (VAS). The VAS records the subject's self-rated health status which ranges from a score of 0 (worst health you can imagine) to 100 (best health you can imagine). A higher VAS score represents a better quality of life.

  21. (Randomized Arm) 6MHW Test

    Time frame: Baseline, 6, and 12 months post-implantation

    Six Minute Hall Walk (6MHW) Test Distance

  22. (Randomized Arm) 6MHW Test (Subject Based COVID-19 Sensitivity Analysis)

    Time frame: Baseline, 6, and 12 months post-implantation

    Six Minute Hall Walk (6MHW) Test Distance

  23. (Randomized Arm) Safety: Freedom From DSRCs

    Time frame: 12 months post-implantation

    Freedom from device/system related complications (DSRCs)

  24. (Single Arm) Composite Outcome of (1) HFHs and (2) Intravenous Diuretic Visits

    Time frame: 12 months post-implantation

    The composite outcome of:

    • The number of recurrent HFHs
    • The number of emergency department/hospital outpatient observation visits for intravenous diuretic therapy

    added together with equal weighting into a total number of events

  25. (Single Arm) Composite Outcome of (1) HFHs and (2) Intravenous Diuretic Visits [Follow-up Based COVID-19 Sensitivity Analysis]

    Time frame: Events were analyzed through March 13, 2020 for pre-COVID-19 analysis (median follow-up: 5.4 months) and from March 13, 2020 through the end of subject's follow-up for during COVID-19 analysis (median follow-up: 11.2 months).

    The composite outcome of:

    • The number of recurrent HFHs
    • The number of emergency department/hospital outpatient observation visits for intravenous diuretic therapy

    added together with equal weighting into a total number of events

  26. (Single Arm) Composite Outcome of (1) HFHs and (2) Intravenous Diuretic Visits [Subject Based COVID-19 Sensitivity Analysis]

    Time frame: 12 Months Post Implantation

    The composite outcome of:

    • The number of recurrent HFHs
    • The number of emergency department/hospital outpatient observation visits for intravenous diuretic therapy

    added together with equal weighting into a total number of events

  27. (Single Arm) Composite Outcome of (1) HFHs and (2) Intravenous Diuretic Visits [Event Based COVID-19 Sensitivity Analysis]

    Time frame: 12 Months Post Implantation

    The composite outcome of:

    • The number of recurrent HFHs
    • The number of emergency department/hospital outpatient observation visits for intravenous diuretic therapy

    added together with equal weighting into a total number of events

  28. (Single Arm) Intravenous Diuretic Visits

    Time frame: 12 months post-implantation

    The number of emergency department/hospital outpatient observation (ED/OP) visits for intravenous diuretic therapy

  29. (Single Arm) Intravenous Diuretic Visits [Follow-up Based COVID-19 Sensitivity Analysis]

    Time frame: Events were analyzed through March 13, 2020 for pre-COVID-19 analysis (median follow-up: 5.4 months) and from March 13, 2020 through the end of subject's follow-up for during COVID-19 analysis (median follow-up: 11.2 months).

    The number of emergency department/hospital outpatient observation (ED/OP) visits for intravenous diuretic therapy

  30. (Single Arm) Intravenous Diuretic Visits [Subject Based COVID-19 Sensitivity Analysis]

    Time frame: 12 months post-implantation

    The number of emergency department/hospital outpatient observation (ED/OP) visits for intravenous diuretic therapy

  31. (Single Arm) Intravenous Diuretic Visits [Event Based COVID-19 Sensitivity Analysis]

    Time frame: 12 Months Post Implantation

    The number of emergency department/hospital outpatient observation (ED/OP) visits for intravenous diuretic therapy

  32. (Single Arm) HFHs

    Time frame: 12 months post-implantation

    The number of HFHs

  33. (Single Arm) HFHs [Follow-Up Based COVID-19 Sensitivity Analysis]

    Time frame: Events were analyzed through March 13, 2020 for pre-COVID-19 analysis (median follow-up: 5.4 months) and from March 13, 2020 through the end of subject's follow-up for during COVID-19 analysis (median follow-up: 11.2 months).

    The number of heart failure hospitalizations (HFHs)

  34. (Single Arm) HFHs [Subject Based COVID-19 Sensitivity Analysis]

    Time frame: 12 Months Post Implantation

    The number of heart failure hospitalizations (HFHs)

  35. (Single Arm) HFHs [Event Based COVID-19 Sensitivity Analysis]

    Time frame: 12 Months Post Implantation

    The number of heart failure hospitalizations (HFHs)

  36. (Single Arm) All-cause Mortality

    Time frame: 12 months post-implantation

    The number of deaths of any cause

  37. (Single Arm) All-cause Mortality [Follow-Up Based COVID-19 Sensitivity Analysis]

    Time frame: Events were analyzed through March 13, 2020 for pre-COVID-19 analysis (median follow-up: 5.4 months) and from March 13, 2020 through the end of subject's follow-up for during COVID-19 analysis (median follow-up: 11.2 months).

    The number of deaths of any cause

  38. (Single Arm) All-cause Mortality [Subject Based COVID-19 Sensitivity Analysis]

    Time frame: 12 Months Post Implantation

    The number of deaths of any cause

  39. (Single Arm) All-cause Mortality [Event Based COVID-19 Sensitivity Analysis]

    Time frame: 12 Months Post Implantation

    The number of deaths of any cause

  40. (Single Arm) Safety: Freedom From DSRCs

    Time frame: 12 months post-implantation

    Proportion of subjects with freedom from device/system related complications (DSRCs)

  41. (Single Arm) HFHs Post- vs. Pre-implantation [Elevated NT-proBNP/BNP Only Group]

    Time frame: 12 months post-implantation vs 12 months pre-implantation

    The number of HFHs at 12 months post-implantation compared to the number of HFHs in the 12 months prior to implantation

  42. (Single Arm) HFHs Post- vs. Pre-implantation [Previous HF Hospitalization Only Group]

    Time frame: 12 months post-implantation vs 12 months pre-implantation

    The number of HFHs at 12 months post-implantation compared to the number of HFHs in the 12 months prior to implantation

  43. (Single Arm) HFHs Post- vs. Pre-implantation [Elevated NT-proBNP/BNP and Previous HF Hospitalization Group]

    Time frame: 12 months post-implantation vs 12 months pre-implantation

    The number of HFHs at 12 months post-implantation compared to the number of HFHs in the 12 months prior to implantation

Other outcomes

  1. (Randomized Arm) Cardiovascular Mortality

    Time frame: 12 months post-implantation

    The number of deaths with cardiovascular cause

  2. (Randomized Arm) All-cause Hospitalizations

    Time frame: 12 months post-implantation

    The number of hospitalizations of any cause

  3. (Randomized Arm) Frequency of Subject PA Pressure Uploads

    Time frame: 12 months post-implantation

    The frequency of subject uploads of PA pressure

  4. (Randomized Arm) HF Medication Changes

    Time frame: 12 months post-implantation

    The number of changes in HF medications

  5. (Randomized Arm) PA Pressure Measurements [Mixed Model Analysis]

    Time frame: Baseline through 12 months post-implantation

    Changes in PA pressure relative to baseline for systolic, diastolic, and mean PA pressures analyzed using a mixed linear model at fixed time points (Baseline, 6 months, and 12 months) producing least-squares means.

  6. (Randomized Arm) PA Pressure Measurements [AUC Analysis]

    Time frame: Baseline through 12 months post-implantation

    Changes in PA pressure relative to baseline for systolic, diastolic, and mean PA pressures analyzed using an area under the curve (AUC) analysis of change from baseline on all PA pressure readings through 12 months.

  7. (Randomized Arm) BNP

    Time frame: 6 months post-implantation

    Change in BNP measurements from baseline

  8. (Randomized Arm) BNP

    Time frame: 12 months post-implantation

    Change in BNP measurements from baseline

  9. (Randomized Arm) NT-proBNP

    Time frame: 6 months post-implantation

    Change in NT-proBNP measurements from baseline

  10. (Randomized Arm) NT-proBNP

    Time frame: 12 months post-implantation

    Change in NT-proBNP measurements from baseline

  11. (Randomized Arm) HFHs Post- vs. Pre-implantation [Treatment Group]

    Time frame: 12 months post-implantation vs 12 months pre-implantation

    The number of HFHs at 12 months post-implantation compared to the number of HFHs in the 12 months prior to implantation in the Treatment group

  12. (Randomized Arm) HFHs Post- vs. Pre-implantation [Control Group]

    Time frame: 12 months post-implantation vs 12 months pre-implantation

    The number of HFHs at 12 months post-implantation compared to the number of HFHs in the 12 months prior to implantation

  13. (Single Arm) KCCQ-12 [Mixed Model Analysis]

    Time frame: 6 months post-implantation

    Health status as assessed by the KCCQ-12 The Kansas City Cardiomyopathy Questionnaire (KCCQ-12) is a validated health-related quality of life measure for heart failure and was qualified by the FDA as a medical device development tool in 2017. The KCCQ-12 quantifies physical function, symptoms (frequency, severity, and recent change), social function, self-efficacy and knowledge, and quality of life on a scale from 0 to 100. An overall summary score (OSS) is derived by averaging scores from each domain, with a higher score reflecting a better health status.

  14. (Single Arm) KCCQ-12 [Mixed Model Analysis]

    Time frame: 12 months post-implantation

    Health status as assessed by the KCCQ-12 The Kansas City Cardiomyopathy Questionnaire (KCCQ-12) is a validated health-related quality of life measure for heart failure and was qualified by the FDA as a medical device development tool in 2017. The KCCQ-12 quantifies physical function, symptoms (frequency, severity, and recent change), social function, self-efficacy and knowledge, and quality of life on a scale from 0 to 100. An overall summary score (OSS) is derived by averaging scores from each domain, with a higher score reflecting a better health status.

  15. (Single Arm) EQ-5D-5L [Mixed Model Analysis]

    Time frame: 6 months post-implantation

    Health status as assessed by the EQ-5D-5L Questionnaire. The data represents the EQ Visual Analogue Scale (VAS) subscale. The VAS records the subject's self-rated health status which ranges from a score of 0 (worst health you can imagine) to 100 (best health you can imagine). A higher VAS score for represents a better quality of life.

  16. (Single Arm) EQ-5D-5L [Mixed Model Analysis]

    Time frame: 12 months post-implantation

    Health status as assessed by the EQ-5D-5L Questionnaire. The data represents the EQ Visual Analogue Scale (VAS) subscale. The VAS records the subject's self-rated health status which ranges from a score of 0 (worst health you can imagine) to 100 (best health you can imagine). A higher VAS score for represents a better quality of life.

  17. (Single Arm) 6MHW Test [Mixed Model Analysis]

    Time frame: 6 months post-implantation

    6MHW Test Distance

  18. (Single Arm) 6MHW Test [Mixed Model Analysis]

    Time frame: 12 months post-implantation

    6MHW Test Distance

  19. (Single Arm) Cardiovascular Mortality

    Time frame: 12 months post-implantation

    The number of deaths of cardiovascular cause

  20. (Single Arm) All-cause Hospitalizations

    Time frame: 12 months post-implantation

    The number of hospitalizations of any cause

  21. (Single Arm) Frequency of Subject PA Pressure Uploads - Daily Compliance

    Time frame: 12 months post-implantation

    The frequency of subject uploads of PA pressure

  22. (Single Arm) Frequency of Subject PA Pressure Uploads - Weekly Compliance

    Time frame: 12 months post-implantation

    The frequency of subject uploads of PA pressure

  23. (Single Arm) HF Medication Changes

    Time frame: 12 months post-implantation

    The number of changes in HF medications

  24. (Single Arm) PA Pressure Measurements [Mixed Model Analysis]

    Time frame: Baseline through 12 months post-implantation

    Changes in PA pressure relative to baseline for systolic, diastolic, and mean PA pressures analyzed using a mixed linear model at fixed time points (Baseline, 6 months, and 12 months) producing least-squares means.

  25. (Single Arm) PA Pressure Measurements [AUC Analysis]

    Time frame: Baseline through 12 months post-implantation

    Changes in PA pressure relative to baseline for systolic, diastolic, and mean PA pressures analyzed using area under the curve (AUC) analysis of PA pressure across the full follow-up period

  26. (Single Arm) NT-proBNP (or BNP) [Mixed Model Analysis]

    Time frame: 6 months post-implantation

    Either change in N-terminal pro-brain natriuretic peptide (NT-proBNP) or Brain natriuretic peptide (BNP) measurements at 6 months visits from baseline.

  27. (Single Arm) NT-proBNP (or BNP) [Mixed Model Analysis]

    Time frame: 12 months post-implantation

    Either change in N-terminal pro-brain natriuretic peptide (NT-proBNP) or Brain natriuretic peptide (BNP) measurements at 6 months and 12 months visits from baseline.

Sponsors and collaborators

Lead sponsor

Abbott Medical Devices

Industry

Registry information

Acronym: GUIDE-HF

Important dates

Study start
2018
Primary completion
2023
Study completion
2023
First posted
Jan 2, 2018
Registry last updated
Aug 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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