NCT02091011

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,600 (actual)
• Sponsor: Boston Scientific Corporation · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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)

Conditions

• Implantable Cardioverter Defibrillators
• CRT-D Cardiac Resynchronization Therapy Defibrillator

Timeline

• Start date: 2014-01-27
• Primary completion: 2021-08-01
• Completion: 2021-08-01
• First posted: 2014-03-19
• Last updated: 2022-08-02

Locations

80 sites across 8 countries: United States, Canada, Germany, Japan, South Korea, Spain, Switzerland, United Kingdom