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

Boston Scientific

Status: Completed

Conditions: Implantable Cardioverter Defibrillators; CRT-D Cardiac Resynchronization Therapy Defibrillator

Study type: Observational

Funder types: Industry

Identifiers

NCT02091011

PDM 90912475

Details and patient eligibility

About

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)

Enrollment: 1,600 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

1,600 participants in 1 patient group

Cohort group

Description:

Subjects who have been implanted within 30 days with a commercially available Boston Scientific ICD or a CRT-D device