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

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ClinicalTrials.gov Identifier: NCT01227785
Recruitment Status : Completed
First Posted : October 25, 2010
Results First Posted : April 8, 2014
Last Update Posted : April 25, 2014
Sponsor:
Collaborator:
University of Rochester
Information provided by (Responsible Party):
Guidant Corporation

Brief Summary:

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.


Condition or disease Intervention/treatment
Sudden Cardiac Death Heart Failure Device: INCEPTA ICD or CRT-D

Detailed Description:

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.


Study Type : Observational
Actual Enrollment : 120 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Next Generation INCEPTA ICD and CRT-D Field Following Study: Respiratory Rate Trend Evaluation in Heart Failure (HF) Patients
Study Start Date : October 2010
Actual Primary Completion Date : December 2011
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure
U.S. FDA Resources

Group/Cohort Intervention/treatment
INCEPTA ICD and CRT-D
ICD and CRT-D indicated patients were included in the study. Overall patient population, CRT-D or ICD populations, and patients experiencing or not experiencing a protocol-defined heart failure event were included (dependent on outcomes measured).
Device: INCEPTA ICD or CRT-D



Primary Outcome Measures :
  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 Outcome Measures :
  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).



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients should be selected from the investigator's general population and be indicated for an ICD or CRT-D implantation.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01227785


Locations
Germany
Deutsches Herzzentrum Berlin
Berlin, Germany
Sponsors and Collaborators
Guidant Corporation
University of Rochester

Responsible Party: Guidant Corporation
ClinicalTrials.gov Identifier: NCT01227785     History of Changes
Other Study ID Numbers: NOTICE-HF 0410
First Posted: October 25, 2010    Key Record Dates
Results First Posted: April 8, 2014
Last Update Posted: April 25, 2014
Last Verified: April 2014

Additional relevant MeSH terms:
Heart Failure
Death
Death, Sudden, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Heart Arrest
Death, Sudden