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

Completed

Conditions: Sudden Cardiac Death
Heart Failure

Interventions: Device: INCEPTA ICD or CRT-D

Registration Number: NCT01227785

Lead Sponsor: 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.

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 120

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

Study & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
INCEPTA ICD and CRT-D	INCEPTA ICD or 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).

Primary Outcome Measures

Name	Time	Method
Clinical Performance for Left Ventricular (LV) Sensing Amplitude at Implant for CRT-D Patients	implant	Left Ventricular (LV) Sensed Amplitude results were reported at implant for CRT-D patients.
Clinical Performance at Pre-discharge for LV Sensing Amplitude for CRT-D Patients	pre-discharge	Left Ventricular (LV) Sensed Amplitude results were reported pre-discharge for CRT-D patients.
Clinical Performance at1-month for Left Ventricular (LV) Sensing Amplitude for CRT-D Patients	1-month	LV Sensed Amplitude results were reported at 1-month post-implant for CRT-D patients.
Clinical Performance at Implant for Right Atrium (RA) Sensing Amplitude	implant	RA Sensed Amplitude results were reported for implant for CRT-D and ICD patients
Clinical Performance at Pre-discharge for RA Sensing Amplitude	pre-discharge	RA Sensed Amplitude results were reported at pre-discharge for CRT-D and ICD patients
Clinical Performance at1-month for RA Sensing Amplitude	1-month	RA Sensed Amplitude results were reported at 1-month post-implant for CRT-D and ICD patients
Clinical Performance at Implant for Right Ventricle (RV) Sensing Amplitude	implant	RV Sensed Amplitude results were reported at implant for CRT-D and ICD patients
Clinical Performance at Pre-discharge for Right Ventricle (RV) Sensing Amplitude	pre-discharge	RV Sensed Amplitude results were reported at pre-discharge for CRT-D and ICD patients
Clinical Performance at1-month for Right Ventricle (RV) Sensing Amplitude	1month	RV Sensed Amplitude results were reported at 1-month post-implant for CRT-D and ICD patients
Clinical Performance at Implant for LV Pacing Threshold	implant	LV pacing threshold results were reported for CRT-D patients at implant.
Clinical Performance at Pre-discharge for LV Pacing Threshold	pre-discharge	LV pacing threshold results were reported at pre-discharge for CRT-D patients.
Clinical Performance at1-month for LV Pacing Threshold	1-month	LV pacing threshold results were reported at 1-month post-implant for CRT-D patients.
Clinical Performance at Implant for RV Pacing Threshold	implant	RV pacing threshold results were reported at implant
Clinical Performance at Pre-discharge for RV Pacing Threshold	pre-discharge	RV pacing threshold results were reported at pre-discharge
Clinical Performance at 1-month for RV Pacing Threshold	1-month	RV pacing threshold results were reported at 1-month post-implant
Clinical Performance at Implant for RA Pacing Threshold	implant	RA pacing threshold results were reported for implant
Clinical Performance at Pre-discharge for RA Pacing Threshold	pre-discharge	RA pacing threshold results were reported at pre-discharge
Clinical Performance at 1-month for RA Pacing Threshold	1-month	RA pacing threshold results were reported at 1-month post-implant
Clinical Performance at Implant LV Pacing Impedance for CRT-D.	implant	LV pacing impedance results at implant were measured in CRT-D.
Clinical Performance at Pre-discharge for LV Pacing Impedance for CRT-D.	pre-discharge	LV pacing impedance results were reported for pre-discharge visit
Clinical Performance at 1-month for LV Pacing Impedance for CRT-D.	1-month	LV pacing impedance results were reported at 1-month post-implant
Clinical Performance at Implant for RV Pacing Impedance	implant	RV pacing impedance results were reported at implant
Clinical Performance at Pre-discharge for RV Pacing Impedance	pre-discharge	RV pacing impedance results were reported for pre-discharge
Clinical Performance at 1-month for RV Pacing Impedance	1-month	RV pacing impedance results were reported at 1-month post-implant
Clinical Performance at Implant for RA Pacing Impedance	implant	RA pacing impedance results were reported at implant
Clinical Performance at Pre-discharge for RA Pacing Impedance	pre-discharge	RA pacing impedance results were reported at pre-discharge
Clinical Performance at 1-month for RA Pacing Impedance	1-month	RA pacing impedance results were reported at 1-month post-implant
Product Experiences Reported by the Site for All Patients for Study Duration	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.
Induced Ventricular Tachycardia / Ventricular Fibrillation (VT/VF) Episode Successful Conversion Rates at Implant	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.
Induced VT/VF Episode Successful Conversion Rates at 1-month	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.
Induced VT/VF Episode Successful Conversion Rates at 3-months	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.
Induced Episode Detection Times at Implant	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.
Induced Episode Detection Times at 1-month	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.
Induced Episode Detection Times at 3 Months	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.
Spontaneous Episode Conversion Success Rate at 3 Months	3-month	Of the total patients that experienced a spontaneous episode, the % of patients with a spontaneous rhythm conversion that was successful was determined.
Wanded Telemetry Issues at Pre-discharge Follow-up	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

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