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

Recruiting now · Phase 4

Conditions studied: Arrythmia, Cardiomyopathies

In brief

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

Key facts

Study ID

NCT05034432

Run by

University of Rochester

People needed

100

Starts

2022-05-27

Expected to finish

2027-06-30

Last updated by the study team

2026-07-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age > 18 years
• 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.

You may not qualify if…

• Past successful VTA ablation without recurrent VTA prior to LVAD implant (Patients who continue to experience VTA post ablation and pre LVAD implant qualify to be enrolled)
• Participation in other clinical trials (observational registries are allowed with approval)
• Unable or unwilling to provide informed consent

Where it is running

• Banner University Medical Center — Phoenix, Arizona, United States (enrolling)
• UCLA Cardiac Arrthmia Center — Los Angeles, California, United States (enrolling)
• University of California San Francisco — San Francisco, California, United States (enrolling)
• Medstar Washington Hospital Center — Washington D.C., District of Columbia, United States (enrolling)
• Piedmont Heart Institute — Atlanta, Georgia, United States (enrolling)
• Emory University — Atlanta, Georgia, United States (enrolling)
• Ascension St. Vincent Indianapolis — Indianapolis, Indiana, United States (enrolling)
• Univedrsity of Louisville — Louisville, Kentucky, United States (enrolling)
• Johns Hopkins University — Baltimore, Maryland, United States (enrolling)
• Tufts Medical Center — Boston, Massachusetts, United States (enrolling)
• Henry Ford Health — Detroit, Michigan, United States (enrolling)
• Columbia University Medical Center — New York, New York, United States (enrolling)
• University of Rochester — Rochester, New York, United States (enrolling)
• Cleveland Clinic — Cleveland, Ohio, United States (enrolling)
• University of Pennsylvania — Philadelphia, Pennsylvania, United States (enrolling)
• UPMC — Pittsburgh, Pennsylvania, United States (enrolling)
• Medical University of South Carolina — Charleston, South Carolina, United States (enrolling)
• Vanderbilt University Medical Center — Nashville, Tennessee, United States (enrolling)
• Houston Methodist Hospital — Houston, Texas, United States (enrolling)

Full record on ClinicalTrials.gov

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