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Completed

NCT Number: NCT01227785

Next Generation INCEPTA Implantable Cardioverter Defibrillator (ICD) and Cardiac Resynchronization Therapy (CRT-D) Field Following Study

This study has 2 purposes:

The first purpose of the study is to test a new family of Boston Scientific Implantable Cardioverter Defibrillators ("ICDs") and cardiac resynchronization therapy ICDs ("CRT-Ds") and show how well these new devices work in patients. This new family is called the INCEPTA ICD and the INCEPTA CRT-D.

The second purpose of the study is to collect data from a feature that monitors breathing. It is called the Respiratory Rate Trend (RRT). These data will help to better understand how changes in breathing relate to changes in clinical conditions.

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Key information

Conditions

Sudden Cardiac Death Cardiovascular Diseases Death Death, Sudden Death, Sudden, Cardiac Heart Arrest Heart Diseases Heart Failure Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Deutsches Herzzentrum Berlin

Berlin, State of Berlin, Germany

About this study

Study Purpose

Study purpose I:

To evaluate and document appropriate clinical performance of the INCEPTA (DR and VR) implantable cardioverter defibrillator (ICD) system and the INCEPTA cardiac resynchronization therapy ICD (CRT-D) system and associated application software.

Study purpose II:

Demonstrate the clinical relevance of chronic ambulatory daily median Respiratory Rate Trend (RRT) in HF patients

Study Device

  • INCEPTA (DR and VR) implantable cardioverter defibrillator (ICD) system (Models F160, F161, F162, F163)
  • INCEPTA cardiac resynchronization therapy ICD (CRT-D) system (Models P162, P163, P165)

Indication ICD / CRT-D Indication according to standard clinical practice

Study Objectives

The study has two primary objectives, linked to the respective study purposes:

For purpose I:

The objective is to collect data on the clinical performance of the INCEPTA ICD and CRT-D devices during standard clinical use at implant, pre-discharge and at a 1-month post-implant. Clinical performance included analysis of pacing thresholds, pacing impedance, sensing thresholds, number of successfully converted VT/VF episodes, induced episodes detection times, spontaneous episodes, wanded telemetry, adverse events (AEs) and product experiences.

For purpose II:

The objective is to show that daily median respiratory rate increases more in patients who experience an HF-event (Group 1) than in patients who do not experience an HF-event (Group 2).

This is a prospective, multi-centre, field following study.

Up to 35 study centers in the International geography will enrol 120 patients.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients who are willing and capable of providing informed consent, undergoing a device implant, participating in all testing associated with this clinical study;
  • Patients whose age is 18 or above, or of legal age to give informed consent specific to national law
  • Patients indicated for an ICD according to normal clinical practice (for those patients receiving an INCEPTA ICD).

-As soon as 20 ICD patients are included in the study for purpose I, only NYHA Class III patients will be allowed in the study.

  • New York Heart Association (NYHA) Class III patients indicated for a CRT-D according to normal clinical practice (for those patients receiving an INCEPTA CRT-D).

Exclusion criteria

  • Women of childbearing potential who are or might be pregnant at the time of the study (method of assessment upon physician's discretion)
  • Enrolled in any other concurrent study.
  • Inability or refusal to comply with the follow-up schedule
  • Patients that have received routinely scheduled intravenous inotropic therapy as part of their drug regimen within the past 90 days
  • Patients prescribed to positive airway pressure therapy
  • A life expectancy of less than 1 year, per physician discretion
  • Patient in NYHA Class IV during the last 4 weeks

Treatment and study plan

INCEPTA ICD or CRT-D

Device

Primary outcomes

  1. Clinical Performance for Left Ventricular (LV) Sensing Amplitude at Implant for CRT-D Patients

    Time frame: implant

    Left Ventricular (LV) Sensed Amplitude results were reported at implant for CRT-D patients.

  2. Clinical Performance at Pre-discharge for LV Sensing Amplitude for CRT-D Patients

    Time frame: pre-discharge

    Left Ventricular (LV) Sensed Amplitude results were reported pre-discharge for CRT-D patients.

  3. Clinical Performance at1-month for Left Ventricular (LV) Sensing Amplitude for CRT-D Patients

    Time frame: 1-month

    LV Sensed Amplitude results were reported at 1-month post-implant for CRT-D patients.

  4. Clinical Performance at Implant for Right Atrium (RA) Sensing Amplitude

    Time frame: implant

    RA Sensed Amplitude results were reported for implant for CRT-D and ICD patients

  5. Clinical Performance at Pre-discharge for RA Sensing Amplitude

    Time frame: pre-discharge

    RA Sensed Amplitude results were reported at pre-discharge for CRT-D and ICD patients

  6. Clinical Performance at1-month for RA Sensing Amplitude

    Time frame: 1-month

    RA Sensed Amplitude results were reported at 1-month post-implant for CRT-D and ICD patients

  7. Clinical Performance at Implant for Right Ventricle (RV) Sensing Amplitude

    Time frame: implant

    RV Sensed Amplitude results were reported at implant for CRT-D and ICD patients

  8. Clinical Performance at Pre-discharge for Right Ventricle (RV) Sensing Amplitude

    Time frame: pre-discharge

    RV Sensed Amplitude results were reported at pre-discharge for CRT-D and ICD patients

  9. Clinical Performance at1-month for Right Ventricle (RV) Sensing Amplitude

    Time frame: 1month

    RV Sensed Amplitude results were reported at 1-month post-implant for CRT-D and ICD patients

  10. Clinical Performance at Implant for LV Pacing Threshold

    Time frame: implant

    LV pacing threshold results were reported for CRT-D patients at implant.

  11. Clinical Performance at Pre-discharge for LV Pacing Threshold

    Time frame: pre-discharge

    LV pacing threshold results were reported at pre-discharge for CRT-D patients.

  12. Clinical Performance at1-month for LV Pacing Threshold

    Time frame: 1-month

    LV pacing threshold results were reported at 1-month post-implant for CRT-D patients.

  13. Clinical Performance at Implant for RV Pacing Threshold

    Time frame: implant

    RV pacing threshold results were reported at implant

  14. Clinical Performance at Pre-discharge for RV Pacing Threshold

    Time frame: pre-discharge

    RV pacing threshold results were reported at pre-discharge

  15. Clinical Performance at 1-month for RV Pacing Threshold

    Time frame: 1-month

    RV pacing threshold results were reported at 1-month post-implant

  16. Clinical Performance at Implant for RA Pacing Threshold

    Time frame: implant

    RA pacing threshold results were reported for implant

  17. Clinical Performance at Pre-discharge for RA Pacing Threshold

    Time frame: pre-discharge

    RA pacing threshold results were reported at pre-discharge

  18. Clinical Performance at 1-month for RA Pacing Threshold

    Time frame: 1-month

    RA pacing threshold results were reported at 1-month post-implant

  19. Clinical Performance at Implant LV Pacing Impedance for CRT-D.

    Time frame: implant

    LV pacing impedance results at implant were measured in CRT-D.

  20. Clinical Performance at Pre-discharge for LV Pacing Impedance for CRT-D.

    Time frame: pre-discharge

    LV pacing impedance results were reported for pre-discharge visit

  21. Clinical Performance at 1-month for LV Pacing Impedance for CRT-D.

    Time frame: 1-month

    LV pacing impedance results were reported at 1-month post-implant

  22. Clinical Performance at Implant for RV Pacing Impedance

    Time frame: implant

    RV pacing impedance results were reported at implant

  23. Clinical Performance at Pre-discharge for RV Pacing Impedance

    Time frame: pre-discharge

    RV pacing impedance results were reported for pre-discharge

  24. Clinical Performance at 1-month for RV Pacing Impedance

    Time frame: 1-month

    RV pacing impedance results were reported at 1-month post-implant

  25. Clinical Performance at Implant for RA Pacing Impedance

    Time frame: implant

    RA pacing impedance results were reported at implant

  26. Clinical Performance at Pre-discharge for RA Pacing Impedance

    Time frame: pre-discharge

    RA pacing impedance results were reported at pre-discharge

  27. Clinical Performance at 1-month for RA Pacing Impedance

    Time frame: 1-month

    RA pacing impedance results were reported at 1-month post-implant

  28. Product Experiences Reported by the Site for All Patients for Study Duration

    Time frame: Overall study results

    Product experiences reported may include the shock impedance noise display, problems encountered with the universal serial bus (USB), a program parameter mismatch, reverse mode switches, electrogram (EGM) noise without oversensing, lead connection issues, or customer device feedback.

  29. Induced Ventricular Tachycardia / Ventricular Fibrillation (VT/VF) Episode Successful Conversion Rates at Implant

    Time frame: implant

    The % of successful conversions after inducing a VT/VF episode was analyzed for available data from CRT and ICD group patients. All episodes of induced VT/VF that resolved with successful conversion were counted from the total attempted conversions and reported as the % of successful conversions from those attempted.

  30. Induced VT/VF Episode Successful Conversion Rates at 1-month

    Time frame: 1-month

    The % of successful conversions after inducing a VT/VF episode was analyzed for available data from CRT and ICD group patients. All episodes of induced VT/VF that resolved with successful conversion were counted from the total attempted conversions and reported as the % of successful conversions from those attempted.

  31. Induced VT/VF Episode Successful Conversion Rates at 3-months

    Time frame: 3-month

    The % of successful conversions after inducing a VT/VF episode was analyzed for available data from CRT and ICD group patients. All episodes of induced VT/VF that resolved with successful conversion were counted from the total attempted conversions and reported as the % of successful conversions from those attempted.

  32. Induced Episode Detection Times at Implant

    Time frame: implant

    The mean time it took to complete a successful conversion after inducing a VT/VF episode was analyzed for available data from CRT and ICD group patients. The time was recorded (in seconds) for the time duration that was required to successfully convert the patient after inducing VT/VF.

  33. Induced Episode Detection Times at 1-month

    Time frame: 1-month

    The mean time it took to complete a successful conversion after inducing a VT/VF episode was analyzed for available data from CRT and ICD group patients. The time was recorded (in seconds) for the time duration that was required to successfully convert the patient after inducing VT/VF.

  34. Induced Episode Detection Times at 3 Months

    Time frame: 3-month

    The mean time it took to complete a successful conversion after inducing a VT/VF episode was analyzed for available data from CRT and ICD group patients. The time was recorded (in seconds) for the time duration that was required to successfully convert the patient after inducing VT/VF.

  35. Spontaneous Episode Conversion Success Rate at 3 Months

    Time frame: 3-month

    Of the total patients that experienced a spontaneous episode, the % of patients with a spontaneous rhythm conversion that was successful was determined.

  36. Wanded Telemetry Issues at Pre-discharge Follow-up

    Time frame: Pre-Discharge visit occurred after implant but prior to 1 month follow-up visit

    The Investigators completed a questionnaire based on the performance of the wanded telemetry during device interrogations at pre-discharge follow-up. The number of problems reported were counted from the entire study cohort.

Secondary outcomes

  1. Evaluate the Daily Median Respiratory Rate Trend in Patients Who Experience a HF-event Compared to Patients Who do Not Experience a HF-event.

    Time frame: Results were captured from implant time window to the first event for patients with HFE, up to an average of 9 months

    A comparison of the change in respiratory rate trend over time was made between patients who experienced a protocol-defined HF event (HFE) (Group1: Patients with a HFE) and patients who did not experience a protocol-defined heart failure event (Group 2: Patients without a HFE). Only patients with at least 3 valid daily respiratory rate values (60%) out of each 5-day window were evaluated. The objective was to show that daily median respiratory rate increases more in patients who experience a HFE (Group 1) than in patients who do not experience an HFE (Group 2). A comparison between patients who experience a HFE (Group 1) and patients who do not experience a HFE (Group 2). Two average daily median respiratory rates were done per patient: 60 to 56 days before an index time and 11 to 7 days before the same index time; the difference between these two averaged daily median respiratory rates was done. Index time=day of the first HFE (Group 1) and day of 6-month visit (Group 2).

Sponsors and collaborators

Lead sponsor

Guidant Corporation

Industry

Collaborators

  • University of Rochester

Registry information

Official study title

Next Generation INCEPTA ICD and CRT-D Field Following Study: Respiratory Rate Trend Evaluation in Heart Failure (HF) Patients

Acronym: NOTICE-HF

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Oct 25, 2010
Registry last updated
Apr 25, 2014

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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