The PIVATAL Study -Study of Ventricular Arrhythmia (VTA) Ablation in Left Ventricular Assist Device (LVAD) Patients
NCT ID: NCT05034432
Last Updated: 2025-09-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
100 participants
INTERVENTIONAL
2022-05-27
2026-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Intra-Op Prophylactic VT ablation
Subjects will get ablation procedure as needed if they were determined to be refractory to medical antiarrhythmic control should undergo catheter-based electrophysiology study and ablation on LVAD support
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
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* Presence of advanced cardiomyopathy (of all INTERMACS classification) and eligible for LVAD implant per the decision of the Heart Failure clinical team
* Implanted cardioverter defibrillator (ICD) any time in past with remote monitoring or planned to undergo ICD (or ICM as an alternative, if an ICD cannot be implanted for a clinical reason) implant within the index hospitalization for LVAD implant
* History of treated or monitored sustained (i.e., \>30 seconds in duration ) VT or VF episode within the past 5 years.
Exclusion Criteria
* Participation in other clinical trials (observational registries are allowed with approval)
* Unable or unwilling to provide informed consent
18 Years
ALL
No
Sponsors
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National Heart, Lung, and Blood Institute (NHLBI)
NIH
University of Rochester
OTHER
Responsible Party
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David Huang
Professor
Principal Investigators
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David Huang, MD
Role: PRINCIPAL_INVESTIGATOR
University of Rochester
Locations
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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
Countries
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Central Contacts
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Kathy Honsinger
Role: CONTACT
Facility Contacts
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Lori Caufield
Role: primary
Raquel Rozich
Role: primary
Other Identifiers
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STUDY00006159
Identifier Type: -
Identifier Source: org_study_id
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