This is a prospective, multi-center, global, single-arm, pivotal investigational study designed to evaluate the safety and effectiveness of the CSP ICD Lead in a subject population indicated for ICD or CRT-D therapy. The clinical investigation will enroll up to 414 subjects at up to 70 participating centers from the United States, Canada, Europe, and Asia Pacific.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
414
Required electrical testing for pacing, sensing, impedance and defibrillation will be completed
Primary Safety Endpoint
Freedom from CSP ICD Lead-related Serious Adverse Device Effects (SADEs) through 3 months post-implant for subjects in which the CSP ICD Lead implant was attempted
Time frame: 3 months post-implant
Primary Effectiveness Endpoint 1
3-month composite success rate of acceptable pacing capture thresholds and R-wave sense amplitudes of the CSP ICD Leads in the subjects with the CSP ICD Lead implanted at the LBBA
Time frame: 3-months post-implant
Primary Effectiveness Endpoint 2
Success rate of the defibrillation testing at implant in the subjects who complete the defibrillation test with the CSP ICD Lead implanted at the LBBA
Time frame: at implant
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Heart Center Research LLC
Huntsville, Alabama, United States
Banner University Medical Center Phoenix
Phoenix, Arizona, United States
Arrhythmia Research Group
Jonesboro, Arkansas, United States
Premier Cardiology, Inc.
Newport Beach, California, United States
University of California at San Diego (UCSD) Medical Center
San Diego, California, United States
MedStar Washington Hospital Center
Washington D.C., District of Columbia, United States
AdventHealth Orlando
Orlando, Florida, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
New York Presbyterian Hospital/Cornell University
New York, New York, United States
The Cleveland Clinic Foundation
Cleveland, Ohio, United States
...and 27 more locations