Phase
Condition
Chest Pain
Arrhythmia
Dysrhythmia
Treatment
FlexAbility SE Ablation Catheter
Clinical Study ID
Ages > 7 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Patient or legally acceptable representative or parent/guardian (as applicable) mustprovide written informed consent prior to any clinical investigation-relatedprocedure
Subjects who have recurrent, drug-refractory, sustained MMVT with non-ischemicstructural heart disease and a clinical decision has been made to use FlexAbility SEfor an ablation procedure prior to enrollment in the research study
Refractory (i.e. not effective, not tolerated or not desired) to at least one ClassI/III anti-arrhythmic medication for treatment of MMVT
Implanted with a market released ICD or CRT-D prior to the Index Ablation Procedure
Able and willing to comply with all study requirements
Exclusion
Exclusion Criteria:
Documented or known intracardiac thrombus or myxoma
Active systemic infection
History of atriotomy or ventriculotomy within 4 weeks prior to the Index AblationProcedure
Patients with prosthetic valves as the catheter may damage the prosthesis
Unable to receive heparin or an acceptable alternative to achieve adequateanticoagulation
Study Design
Connect with a study center
Aurora Denver Cardiology Associates
Aurora, Colorado 80012
United StatesSite Not Available
NCH Healthcare System
Naples, Florida 34102
United StatesActive - Recruiting
Sarasota Memorial Hospital
Sarasota, Florida 34239
United StatesActive - Recruiting
St. Vincent Hospital
Indianapolis, Indiana 46240-0970
United StatesActive - Recruiting
Kansas City Cardiac Arrhythmia Research Foundation
Overland Park, Kansas 66211
United StatesActive - Recruiting
Massachusetts General Hospital
Boston, Massachusetts 02114
United StatesActive - Recruiting
VA Medical Center Minneapolis
Minneapolis, Minnesota 55417
United StatesActive - Recruiting
Carolinas Medical Center
Charlotte, North Carolina 28203
United StatesActive - Recruiting
Integris Baptist Medical Center
Oklahoma City, Oklahoma 73112
United StatesActive - Recruiting
Medical University of South Carolina
Charleston, South Carolina 29425
United StatesActive - Recruiting
Vanderbilt Heart & Vascular Institute
Nashville, Tennessee 37232
United StatesActive - Recruiting
Baylor Scott & White Heart & Vascular Hospital
Dallas, Texas 75226
United StatesActive - Recruiting
Memorial Hermann Hospital
Houston, Texas 77030
United StatesActive - Recruiting
University of Utah Hospital
Salt Lake City, Utah 84132
United StatesActive - Recruiting
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