CRT-D Cardiac Resynchronization Therapy Defibrillator, Implantable Cardioverter Defibrillators
Conditions
Keywords
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.
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)
Interventions
None listed
Sponsors
Boston Scientific Corporation
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 5 years | Battery survival is defined as freedom from surgical replacement of the device due to battery depletion. |
Secondary
| Measure | 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 |
Countries
Canada, Germany, Japan, South Korea, Spain, Switzerland, United Kingdom, United States
Outcome results
None listed