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

NCT05034432 | Recruiting Phase 4

• 2 other identifiers: STUDY00006159R01HL159401
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 19

Brief 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

Conditions

Arrythmia; Cardiomyopathies

Outcome Measures

Primary Outcomes (1)

• Recurrent VTA

  Total VTA events, after accounting for the competing risk of death

  Post LVAD implant until end of follow-up, through study completion, an average of 18 months (minimum 6 months)

Secondary Outcomes (5)

• Number of participants with treatment-related adverse events as assessed by medical records for hospitalization, stroke and heart failure.

  Post LVAD implant until end of follow-up, approximately 18 months

• Mean duration of LVAD implant (and ablation) surgery

  Admission for LVAD implant until hospital discharge (approximately 2-4 weeks)

• Mean duration of ablation

  Admission for LVAD implant until hospital discharge (approximately 2-4 weeks)

• Mean rate of peri-procedural complication

  Admission for LVAD implant until hospital discharge (approximately 2-4 weeks)

• Mean Length of stay in the intensive care unit after LVAD implant

  Admission for LVAD implant until hospital discharge (approximately 2-4 weeks)

Study Arms (2)

Intra-Op Prophylactic VT ablation

EXPERIMENTAL

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

Procedure: Intra-Op Prophylactic VT ablation

Conventional Management

ACTIVE COMPARATOR

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

Other: Conventional Management

Interventions

Intra-Op Prophylactic VT ablation PROCEDURE

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

Intra-Op Prophylactic VT ablation

Conventional Management OTHER

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• University of Rochester: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (19)

Banner University Medical Center

Phoenix, Arizona, 85006, United States

RECRUITING

UCLA Cardiac Arrthmia Center

Los Angeles, California, 90095, United States

RECRUITING

University of California San Francisco

San Francisco, California, 94143, United States

RECRUITING

Medstar Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

RECRUITING

Piedmont Heart Institute

Atlanta, Georgia, 30309, United States

RECRUITING

Emory University

Atlanta, Georgia, 30322, United States

RECRUITING

Ascension St. Vincent Indianapolis

Indianapolis, Indiana, 46260, United States

RECRUITING

Univedrsity of Louisville

Louisville, Kentucky, 40202, United States

RECRUITING

Johns Hopkins University

Baltimore, Maryland, 21287, United States

RECRUITING

Tufts Medical Center

Boston, Massachusetts, 02111, United States

RECRUITING

Henry Ford Health

Detroit, Michigan, 48202, United States

RECRUITING

Columbia University Medical Center

New York, New York, 10026, United States

RECRUITING

University of Rochester

Rochester, New York, 14642, United States

RECRUITING

Cleveland Clinic

Cleveland, Ohio, 44195, United States

RECRUITING

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

UPMC

Pittsburgh, Pennsylvania, 15213, United States

RECRUITING

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

RECRUITING

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

RECRUITING

Houston Methodist Hospital

Houston, Texas, 77030, United States

RECRUITING

MeSH Terms

Conditions

Arrhythmias, Cardiac; Cardiomyopathies

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• David Huang, MD

  University of Rochester

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ann Colasurdo

CONTACT

585-275-1054; ann_colasurdo@urmc.rochester.edu

Kathy Honsinger

CONTACT

585-273-1899

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 29, 2021
• First Posted: September 5, 2021
• Study Start: May 27, 2022
• Primary Completion: April 30, 2026
• Study Completion (Estimated): June 30, 2027
• Last Updated: March 23, 2026

Record last verified: 2026-03

Locations

US (19)