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).
· 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|
|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|