The PIVATAL Study -Study of Ventricular Arrhythmia (VTA) Ablation in Left Ventricular Assist Device (LVAD) Patients

PHASE4RecruitingINTERVENTIONAL
Enrollment

100

Participants

Timeline

Start Date

May 27, 2022

Primary Completion Date

December 31, 2025

Study Completion Date

June 30, 2026

Conditions
ArrythmiaCardiomyopathies
Interventions
PROCEDURE

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

OTHER

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

Trial Locations (19)

10026

RECRUITING

Columbia University Medical Center, New York

14642

RECRUITING

University of Rochester, Rochester

15213

RECRUITING

UPMC, Pittsburgh

19104

RECRUITING

University of Pennsylvania, Philadelphia

20010

RECRUITING

Medstar Washington Hospital Center, Washington D.C.

21287

RECRUITING

Johns Hopkins University, Baltimore

29425

RECRUITING

Medical University of South Carolina, Charleston

30309

RECRUITING

Piedmont Heart Institute, Atlanta

30322

RECRUITING

Emory University, Atlanta

37232

RECRUITING

Vanderbilt University Medical Center, Nashville

40202

RECRUITING

Univedrsity of Louisville, Louisville

44195

RECRUITING

Cleveland Clinic, Cleveland

46260

RECRUITING

Ascension St. Vincent Indianapolis, Indianapolis

48202

RECRUITING

Henry Ford Health, Detroit

77030

RECRUITING

Houston Methodist Hospital, Houston

85006

RECRUITING

Banner University Medical Center, Phoenix

90095

RECRUITING

UCLA Cardiac Arrthmia Center, Los Angeles

94143

RECRUITING

University of California San Francisco, San Francisco

02111

RECRUITING

Tufts Medical Center, Boston

All Listed Sponsors
collaborator

National Heart, Lung, and Blood Institute (NHLBI)

NIH

lead

University of Rochester

OTHER