Abgeschlossen · 2015 bis 2021
Ammann Peter, Schneider Irene
The objective of this non-mandated, prospective, multicenter, global post-market study is to assess the battery and device longevity of Boston Scientific’s (BSC) market-released Implantable Cardioverter Defibrillators (ICD) and CRT-D devices. The study is also designed to validate the device survival information presented in BSC’s Product Performance Report by comparing the pulse generator (PG) survival probability experienced in the study to that of presented in the Product Performance Reports (PPR).
Subjects will be followed for 5 years (approximately 60 months) following implant that may be Extended.
· Determine the rate and cause of all-cause device replacements of BSC’s market-released ICD and CRT-D devices at 5 years post-implantation.
· Evaluate the battery survival of BSC’s market-released ICD and CRT-D devices at 5 years postimplantation. Battery survival is defined as freedom from surgical replacement of the device due to battery depletion.