LONGEVITY Study
Research type
Research Study
Full title
LONGEVITY Study
IRAS ID
174221
Contact name
Mark Earley
Contact email
Sponsor organisation
Boston Scientific, CRM
Duration of Study in the UK
10 years, 2 months, 31 days
Research summary
Research Summary
This LONGEVITY study is being conducted to test the battery and life of specified cardiac devices (Implantable Cardiovascular Defibrillators and CRT-D) that are already approved for use and available on the market. Patients who have already been implanted with one of the specified devices within 30 days, are able and willing to comply with the study requirements, are above the legal age for signing consent, are not on a heart transplant list, who are not expected to live longer than 12 months, have had a previous infection of the lead or device, have not received an available Boston Scientifics device with a battery capacity of 1.5 amp per hour or less and who have not been implanted with a implantable defibrillator system or lead that is under recall at time of enrolment are eligible. The study will be conducted as part of the patient's yearly in-clinic follow-up appointment and will last for 5 years but may continue up to 10 years.Summary of Results
The objective of the post-market LONGEVITY study to collect data on the longevity of a commercially-available Boston Scientific implantable cardioverter defibrillator (ICD) or a cardiac resynchronisation therapy (CRT) device to treat a heart condition. It is estimated that approximately 70% of device recipients will need a generator replacement due to battery depletion over time. The study was to collect information on how long the battery and device lasts and if it matches the sponsors predictions.The conclusion was “Overall model family PG survival probabilities for the cause-specific failure mode of Battery Depletion – ERI, were greater than 98% at 5 years across all device types in the LONGEVITY Study and within 1.5% of the reported 2021 Product Performance rates for these devices.
REC name
London - Surrey Borders Research Ethics Committee
REC reference
15/LO/0634
Date of REC Opinion
22 Apr 2015
REC opinion
Favourable Opinion