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Completed

NCT Number: NCT02279888

CardioMEMS HF System Post Approval Study

The purpose of the CardioMEMS HF System Post Approval Study (PAS) is to evaluate the use of the CardioMEMS HF System in patients with NYHA class III heart failure in a commercial setting.

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Key information

Conditions

Heart Failure Cardiovascular Diseases Congestive Heart Failure Heart Diseases Left-Sided Heart Failure

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

West Virginia Heart Institute

Morgantown, West Virginia, 26505, United States

About this study

The primary objective of this study is to demonstrate the safety and to report clinical performance of the CardioMEMS™ HF System in real world setting.

Prospective, non-randomized, open-label, multi-center, post-market study designed to characterize the use of the CardioMEMS™ HF System in a real-world setting in the US; N=1200. It is the condition of approval study.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Diagnosis of NYHA class III heart failure
  • At least 1 heart failure hospitalization within previous 12 months
  • Patients with reduced LVEF heart failure should be receiving a beta blocker for 3 months and an ACE-I or ARB for one month unless in the investigator's opinion, the patient is intolerant to beta blockers, ACE-I or ARB
  • BMI ≤ 35. Patients with BMI >35 will require their chest circumference to be measured at the axillary level. If > 65 inches the patient will not be eligible for the study.
  • Pulmonary artery branch diameter ≥ 7mm - (implant target artery - assessed during the right heart catheterization)

Exclusion criteria

  • Active infection
  • History of recurrent (> 1) pulmonary embolism or deep vein thrombosis
  • Inability to tolerate a right heart catheterization
  • A major cardiovascular event (e.g., myocardial infarction, open heart surgery, stroke, etc.) within previous 2 months
  • Cardiac resynchronization device (CRT) implanted within previous 3 months
  • Glomerular Filtration Rate (GFR) < 25 ml/min (obtained within 2 weeks of implant) who are non-responsive to diuretic therapy or who are on chronic renal dialysis
  • Congenital heart disease or mechanical right heart valve
  • Likely to undergo heart transplantation or VAD within the next 6 months
  • Known coagulation disorders
  • Hypersensitivity or allergy to aspirin, and/or clopidogrel

Treatment and study plan

CardioMEMS HF System

Device

Pulmonary artery pressure sensor

Primary outcomes

  1. Freedom From Device and/or System Related Complication (DSRC)

    Time frame: two years

    As defined in the study protocol, a DSRC is an adverse event that is, or is possibly, related to the device/system (wireless pressure sensor or external electronics) and has at least one of the following characteristics: is treated with invasive means (other than intramuscular medication or right heart catheterization which is used for diagnostic purposes); results in death of the subject; results in the explant of the device. The primary safety analyses were based on the following objective performance criteria: a) the lower limit of the two-sided 95% confidence interval on the freedom from DSRC rate at 24 months is greater than 80% and b) the lower limit of the two-sided 95% confidence interval on the freedom from pressure sensor failure rate at 24 months is greater than 90%. These primary safety endpoints were tested hierarchically, testing for freedom from DSRCs first, in order to control for multiplicity.

  2. Freedom From Pressure Sensor Failure

    Time frame: two year

    A Sensor failure occurs when no readings can be obtained from it after troubleshooting the system to rule out any problems with the external electronics. The primary safety analyses were based on the following objective performance criteria: a) the lower limit of the two-sided 95% confidence interval on the freedom from DSRC rate at 24 months is greater than 80% and b) the lower limit of the two-sided 95% confidence interval on the freedom from pressure sensor failure rate at 24 months is greater than 90%. These primary safety endpoints were tested hierarchically, testing for freedom from DSRCs first, in order to control for multiplicity.

  3. Heart Failure Hospitalization (HFH) Rate

    Time frame: one year

    Annualized HFH rate parameter at 1 year versus the HFH rate in the year prior to enrollment using an Andersen-Gill method for recurrent events and robust sandwich variances to account for within-subject correlation. If the two-sided, upper 95% confidence interval for the hazard ratio (HR) is less than 1.0, then the primary effectiveness endpoint was met.

Other outcomes

  1. Overall Survival

    Time frame: one and two years

    Survival at 1 year and 24 years post-implant is reported using the Kaplan-Meier method.

  2. Heart Failure Hospitalization or Death Rate

    Time frame: one year

    The annualized HFH or death rate parameter at 1 year was compared to the HFH rate in the year prior to enrollment using an Andersen-Gill method for recurrent events and robust sandwich variances to account for within-subject correlation. If the two-sided, upper 95% confidence interval for the hazard ratio (HR) is less than 1.0, then this effectiveness endpoint was met.

  3. Patient Compliance

    Time frame: One and Two Years

    Total daily readings divided by total number possible for daily readings as well as total weekly readings divided by total possible weekly readings

  4. Training Evaluation - Freedom From DRSC in Academic and Community Hospitals

    Time frame: 2 Years

    To assess the effectiveness of the training program, the safety and effectiveness results were analyzed for Academic Hospitals versus Community Hospitals.

  5. Training Evaluation - Freedom From Pressure Sensor Failure in Academic and Community Hospitals

    Time frame: 2 Years

    To assess the effectiveness of the training program, the safety and effectiveness results were analyzed for Academic Hospitals versus Community Hospitals.

  6. Training Evaluation - HF Hospitalizations Reduction in Academic and Community Hospitals

    Time frame: 2 Years

    To assess the effectiveness of the training program, the safety and effectiveness results were analyzed for Academic Hospitals versus Community Hospitals.

Sponsors and collaborators

Lead sponsor

Abbott Medical Devices

Industry

Registry information

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Oct 31, 2014
Registry last updated
Apr 17, 2024

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

View the official ClinicalTrials.gov record (opens in a new tab)

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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