Subcutaneous Implantable Cardioverter Defibrillator (S-ICD®) System Post Approval Study
Subcutaneous Implantable Cardioverter Defibrillator (S-ICD®) System Post Approval Study
The purpose of the S-ICD Post Approval Study is to document long term safety and effectiveness outcomes associated with the implantation of the SQ-RX pulse generator and Q-TRAK electrode in a commercial clinical setting.
The S-ICD Post Approval Study is a non-randomized registry that will retrospectively enroll subjects who participated in the S-ICD Clinical Investigation (IDE G090013) and prospectively enroll new candidates for the S-ICD System. The target enrollment sample size is 1,616 subjects at up to 150 investigational sites to achieve 1,025 subjects in the analysis cohort at 60 months.
Additional objectives include characterization of long term safety and effectiveness in subjects of varied body habitus and in traditionally underrepresented populations.
Subjects must meet the following criteria to be eligible for inclusion in the study:
Subjects who meet the following criteria must be excluded from the study:
1. Remaining life expectancy of less than 360 days
Enrolled subjects will be followed at the implant procedure, pre-discharge and annual (±60 days) follow-up visits. Subjects are followed according to the standard of care at their participating investigational center.
The primary and secondary safety and effectiveness endpoints will include a compilation of S-ICD IDE study and S-ICD PAS study subject data
Inclusion Criteria:
AND
Exclusion Criteria:
Tampa, Florida 34655, United States
Lombard, Illinois 60181, United States