To demonstrate that scar-based ventricular tachycardia (VT) ablation using the FlexAbility™ ablation catheter system results in a superior clinical outcome compared to routine drug therapy in subjects with documented Monomorphic Ventricular Tachycardia \[MMVT\] (both ischemic and non-ischemic) while maintaining an acceptable safety profile.
Approximately 50 centers in the United States (US) will participate in the study. Additional centers outside the US may be considered, as necessary. The anticipated enrollment duration is 48-60 months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
64
Cardiac ablation catheter system
Number of Subjects Who Experienced an ICD Shock Event.
Primary Effectiveness endpoint: Number reported is number of subjects who experienced an ICD shock event (including both appropriate and inappropriate) through 12 month follow up
Time frame: 12 months
Number of Subjects Who Experienced a Select Serious Adverse Event
Primary Safety Endpoint: Number of subjects who experience a select serious adverse events within the 30 day follow up. Those events are anticipated, associated with catheter ablation, and are cardiovascular, pulmonary, or peripheral vascular in nature, as listed in the Primary Safety Events List.
Time frame: 30 days
Number of Subjects That Had a Cardiovascular (CV) Hospitalizations or CV-related ER Visit
Number of subjects that had a CV hospitalization or CV-related ER visit through 12 month follow up.
Time frame: 12 months
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University of Alabama at Birmingham
Birmingham, Alabama, United States
USC University Hospital
Los Angeles, California, United States
Ronald Reagan UCLA Medical Center
Los Angeles, California, United States
University of California at San Diego (UCSD) Medical Center
San Diego, California, United States
University of California at San Francisco
San Francisco, California, United States
Washington Hospital Center
Washington D.C., District of Columbia, United States
Emory University Hospital
Atlanta, Georgia, United States
Loyola University Medical Center
Maywood, Illinois, United States
Mid-America Cardiology Associates
Kansas City, Kansas, United States
University of Maryland Medical Center
Baltimore, Maryland, United States
...and 28 more locations