LONGEVITY Study. Evaluation of the Device and Battery Longevity of Boston Scientific Market-released ICD and CRT-D Devices

Study Overview
=================
Brief Summary
-----------------
The study is to determine the rate and cause of device replacements at 5 years post-implantation. It will assess the battery and device longevity of the Implantable Cardioverter Defibrillators (ICD) and CRT-D Cardiac Resynchronization Therapy Defibrillator (CRT-D) devices. It will also validate the device survival information given in Boston Scientific's Product Performance Report by comparing the pulse generator (PG) survival probability in the study to that presented in the Product Performance Reports (PPR)

Official Title
-----------------
LONGEVITY Study. Evaluation of the Device and Battery Longevity of Boston Scientific Market-released ICD and CRT-D Devices.

Conditions
-----------------
Implantable Cardioverter Defibrillators, CRT-D Cardiac Resynchronization Therapy Defibrillator

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject has been implanted within 30 days with a commercially available Boston Scientific ICD or a CRT-D device according to current guidelines and/or center's current practice Subject is willing and capable (or appropriate legal representative is willing and capable) of authorizing access to and use of health information as required by an Institution's Institutional Review Board (IRB), Research Ethics Board (REB) or Ethics Committee (EC) Is willing and capable (or appropriate legal representative is willing and capable) of providing authorization/consent for participation in the study. Exclusion Criteria: Subject is unable or unwilling to comply with the study protocol requirements Subject is under the legal age for signing study consent in accordance with state or national law Subject has a life expectancy of less than twelve months Women of childbearing potential who are or might be pregnant at the time of study enrollment (method of assessment upon physician's discretion) Subject on active heart transplant list Subject with any prior pulse generator infection or lead infection which is either systemic or localized Subject received a commercially available Boston Scientific ICD or CRT-D device with a battery capacity of 1.5 amp/hour or less Subject implanted with Boston Scientific's subcutaneous implantable defibrillator system (s-ICD) or has a lead that is under recall/advisory at the time of enrollment
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cohort group<br>Subjects who have been implanted within 30 days with a commercially available Boston Scientific ICD or a CRT-D device | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine the rate and cause of all-cause device replacements of Boston Scientific's market-released ICD and CRT-D devices at 5 years post-implantation. |  | 5 years | 
| Evaluate the battery survival of Boston Scientific's market-released ICD and CRT-D devices at 5 years post-implantation. | Battery survival is defined as freedom from surgical replacement of the device due to battery depletion. | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine the rate and cause of all-cause device replacement of Boston Scientific's market-released ICD and CRT-D devices 1, 2, 3 and 4 years post-implantation. |  | 1, 2, 3, and 4 years | 
| Evaluate battery survival of Boston Scientific's market-released ICD and CRT-D devices at 1, 2, 3 and 4 years post-implantation. |  | 1, 2, 3, and 4 years | 
| Evaluate the device survival of Boston Scientific's market released ICD and CRT-D pulse generators at 5 years post-implantation; and compare it to the survival probability presented in the Product Performance Report (PPR). |  | 5 years | 
| Evaluate potential predictors of device battery longevity at 5 years post-implantation. |  | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
This study is designed to efficiently provide device and battery longevity data on market released, Boston Scientific ICD and CRT-D (Cardiac Resynchronization Therapy Defibrillator) devices. In addition, the data collected will allow for, comparisons of device survival probability estimated in the Product Performance Report versus, those collected in the study. The data collected will also provide a better understanding on the, potential predictors of pulse generator battery longevity.