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The PIVATAL Study -Study of Ventricular Arrhythmia (VTA) Ablation in Left Ventricular Assist Device (LVAD) Patients
Sponsor: University of Rochester
Summary
To investigate the effect of VTA ablation at the time of LVAD implant to see if it can reduce the incidence of VTA after surgery
Official title: Prophylactic Intra-Operative Ventricular Arrhythmia Ablation in High-Risk LVAD Candidates (PIVATAL)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
100
Start Date
2022-05-27
Completion Date
2027-06-30
Last Updated
2026-03-23
Healthy Volunteers
No
Conditions
Interventions
Intra-Op Prophylactic VT ablation
For surgical intra-operative ablation, efforts will be made to identify scarred myocardium based on methods such as cardiac magnetic resonance imaging, nuclear scans, and/or echocardiogram. Electrophysiological mapping may be obtained either pre-surgery or intra-operation. Mapping and ablation will be performed with the currently approved and updated mapping and ablation systems available at each center. Voltage mapping of the ventricle(s) to delineate scars will be carried out through electroanatomic mapping
Conventional Management
To ensure uniformity in control arm, a standardized AAD regimen is recommended among subjects randomized to the medical management control arm. Subjects who are already on a stable AAD regimen, such as amiodarone, sotalol or dofetilide, these should be continued
Locations (19)
Banner University Medical Center
Phoenix, Arizona, United States
UCLA Cardiac Arrthmia Center
Los Angeles, California, United States
University of California San Francisco
San Francisco, California, United States
Medstar Washington Hospital Center
Washington D.C., District of Columbia, United States
Piedmont Heart Institute
Atlanta, Georgia, United States
Emory University
Atlanta, Georgia, United States
Ascension St. Vincent Indianapolis
Indianapolis, Indiana, United States
Univedrsity of Louisville
Louisville, Kentucky, United States
Johns Hopkins University
Baltimore, Maryland, United States
Tufts Medical Center
Boston, Massachusetts, United States
Henry Ford Health
Detroit, Michigan, United States
Columbia University Medical Center
New York, New York, United States
University of Rochester
Rochester, New York, United States
Cleveland Clinic
Cleveland, Ohio, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
UPMC
Pittsburgh, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Houston Methodist Hospital
Houston, Texas, United States