Phase
Condition
Heart Disease
Fast Heart Rate (Tachycardia)
Chest Pain
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 StatesSite Not Available
Sarasota Memorial Hospital
Sarasota, Florida 34239
United StatesSite Not Available
NCH Healthcare System
Naples 4165565, Florida 4155751 34102
United StatesSite Not Available
St. Vincent Hospital
Indianapolis, Indiana 46240-0970
United StatesSite Not Available
St. Vincent Hospital
Indianapolis 4259418, Indiana 4921868 46240-0970
United StatesSite Not Available
Kansas City Cardiac Arrhythmia Research Foundation
Overland Park, Kansas 66211
United StatesSite Not Available
Kansas City Cardiac Arrhythmia Research Foundation
Overland Park 4276873, Kansas 4273857 66211
United StatesSite Not Available
Massachusetts General Hospital
Boston, Massachusetts 02114
United StatesSite Not Available
Massachusetts General Hospital
Boston 4930956, Massachusetts 6254926 02114
United StatesSite Not Available
VA Medical Center Minneapolis
Minneapolis, Minnesota 55417
United StatesSite Not Available
VA Medical Center Minneapolis
Minneapolis 5037649, Minnesota 5037779 55417
United StatesSite Not Available
Carolinas Medical Center
Charlotte, North Carolina 28203
United StatesSite Not Available
Carolinas Medical Center
Charlotte 4460243, North Carolina 4482348 28203
United StatesSite Not Available
Integris Baptist Medical Center
Oklahoma City, Oklahoma 73112
United StatesSite Not Available
Integris Baptist Medical Center
Oklahoma City 4544349, Oklahoma 4544379 73112
United StatesSite Not Available
Medical University of South Carolina
Charleston, South Carolina 29425
United StatesSite Not Available
Medical University of South Carolina
Charleston 4574324, South Carolina 4597040 29425
United StatesSite Not Available
Vanderbilt Heart & Vascular Institute
Nashville, Tennessee 37232
United StatesSite Not Available
Vanderbilt Heart & Vascular Institute
Nashville 4644585, Tennessee 4662168 37232
United StatesSite Not Available
Baylor Scott & White Heart & Vascular Hospital
Dallas, Texas 75226
United StatesSite Not Available
Memorial Hermann Hospital
Houston, Texas 77030
United StatesSite Not Available
Baylor Scott & White Heart & Vascular Hospital
Dallas 4684888, Texas 4736286 75226
United StatesSite Not Available
University of Utah Hospital
Salt Lake City, Utah 84132
United StatesSite Not Available
University of Utah Hospital
Salt Lake City 5780993, Utah 5549030 84132
United StatesSite Not Available

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