Kantonsspital St.Gallen
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LONGEVITY Study

Peter Ammann & Irene Schneider

abstract

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.

Primary Objectives:
· 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.
   
type of project clinical studies
status completed
start of project 2015
end of project 2021
study design prospective, non-randomized, multi-center, single-arm, global clinical study
responsible person Prof. Dr. Peter Ammann