This post-approval study (PAS) is designed to provide continued clinical evidence to confirm the long-term safety and effectiveness of the FlexAbilityTM Ablation Catheter, Sensor EnabledTM (FlexAbility SE) for the treatment of ventricular tachycardia in a post-market environment. This is a prospective, single arm, open-label, multi-center, observational study.
Study Type
OBSERVATIONAL
Enrollment
62
Subjects receive ablation treatment.
NCH Healthcare System
Naples, Florida, United States
St. Vincent Hospital
Indianapolis, Indiana, United States
Kansas City Cardiac Arrhythmia Research Foundation
Overland Park, Kansas, United States
Rate of study device- and/or Study Ablation Procedure-related SAEs through 12 months post Index Ablation Procedure.
Time frame: 12 Month
Composite of 12-month freedom from VT recurrence, death, and cardiac transplantation
Time frame: 12 Month
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Massachusetts General Hospital
Boston, Massachusetts, United States
VA Medical Center Minneapolis
Minneapolis, Minnesota, United States
Carolinas Medical Center
Charlotte, North Carolina, United States
Integris Baptist Medical Center
Oklahoma City, Oklahoma, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Vanderbilt Heart & Vascular Institute
Nashville, Tennessee, United States
Baylor Scott & White Heart & Vascular Hospital
Dallas, Texas, United States
...and 1 more locations