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

Study Overview
=================
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.

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

Conditions
-----------------
Sudden Cardiac Death, Heart Failure

Intervention / Treatment
-----------------
* Device: INCEPTA ICD or CRT-D


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| INCEPTA ICD and CRT-D<br>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<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the Daily Median Respiratory Rate Trend in Patients Who Experience a HF-event Compared to Patients Who do Not Experience a HF-event. | 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). | Results were captured from implant time window to the first event for patients with HFE, up to an average of 9 months |