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

March 19, 2026 updated by: David Huang, University of Rochester

Prophylactic Intra-Operative Ventricular Arrhythmia Ablation in High-Risk LVAD Candidates (PIVATAL)

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This study is a prospective, multicenter, open-label, randomized-controlled clinical trial enrolling 100 patients who are LVAD candidates with a history of VTA who will be randomized in a 1:1 ratio to intra-operative VTA ablation vs. conventional medical management. Comprehensive data on arrhythmia history, medication history will be collected in all randomized subjects. Antiarrhythmic medical therapy will be handled in a uniform pattern between the two arms. Randomized subjects will then be followed per routine schedules for post LVAD implant. Arrhythmia data, ICD therapy, additional procedures including repeat surgery, ramp echocardiographic tests, right heart catheterization and catheter-based VTA ablation will be collected. In addition, adverse events such as unplanned hospitalizations, emergency department visits, clinic visits, and all other aspects of health care utilization will be gathered. The planned average follow-up period will be 18 months.

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Kathy Honsinger
  • Phone Number: 585-273-1899

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85006
        • Recruiting
        • Banner University Medical Center
        • Principal Investigator:
          • Roderick Tung
        • Contact:
    • California
      • Los Angeles, California, United States, 90095
        • Recruiting
        • UCLA Cardiac Arrthmia Center
        • Contact:
        • Principal Investigator:
          • Kalyanam Shivkumar
      • San Francisco, California, United States, 94143
        • Recruiting
        • University of California San Francisco
        • Contact:
        • Principal Investigator:
          • Joshua Moss
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20010
        • Recruiting
        • Medstar Washington Hospital Center
        • Contact:
        • Principal Investigator:
          • Keki Balsara
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Recruiting
        • Emory University
        • Contact:
        • Principal Investigator:
          • Anand Shah
      • Atlanta, Georgia, United States, 30309
        • Recruiting
        • Piedmont Heart Institute
        • Contact:
        • Principal Investigator:
          • Ahmadreza Karimianpour
    • Indiana
      • Indianapolis, Indiana, United States, 46260
        • Recruiting
        • Ascension St. Vincent Indianapolis
        • Contact:
        • Principal Investigator:
          • Sunit-Preet Chaudhry
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • Recruiting
        • Univedrsity of Louisville
        • Contact:
        • Principal Investigator:
          • Auras Ravi Atreya
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Recruiting
        • Johns Hopkins University
        • Contact:
        • Principal Investigator:
          • Chetan Pasrija
    • Massachusetts
      • Boston, Massachusetts, United States, 02111
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Recruiting
        • Henry Ford Health
        • Contact:
        • Principal Investigator:
          • Arfaat Khan
    • New York
      • New York, New York, United States, 10026
        • Recruiting
        • Columbia University Medical Center
        • Contact:
        • Principal Investigator:
          • Nir Uriel
      • Rochester, New York, United States, 14642
        • Recruiting
        • University of Rochester
        • Contact:
          • Lori Caufield
        • Principal Investigator:
          • Sabu Thomas
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Recruiting
        • Cleveland Clinic
        • Contact:
          • Raquel Rozich
          • Phone Number: 216-444-4959
        • Principal Investigator:
          • Jakub Sroubek
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Recruiting
        • University of Pennsylvania
        • Contact:
        • Principal Investigator:
          • Greg Supple
      • Pittsburgh, Pennsylvania, United States, 15213
        • Recruiting
        • UPMC
        • Contact:
        • Principal Investigator:
          • Krishna Kancharla
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Recruiting
        • Medical University of South Carolina
        • Contact:
        • Principal Investigator:
          • Arman Kilic
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Recruiting
        • Vanderbilt University Medical Center
        • Contact:
        • Principal Investigator:
          • Sandip Zalawadiya
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • Houston Methodist Hospital
        • Contact:
        • Principal Investigator:
          • Nilesh Mathuria

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
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
Active Comparator: 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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recurrent VTA
Time Frame: Post LVAD implant until end of follow-up, through study completion, an average of 18 months (minimum 6 months)
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with treatment-related adverse events as assessed by medical records for hospitalization, stroke and heart failure.
Time Frame: Post LVAD implant until end of follow-up, approximately 18 months
Number of participants with any of the following: hospitalization, stroke or right heart failure. Right heart failure assessed by Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) criteria.
Post LVAD implant until end of follow-up, approximately 18 months
Mean duration of LVAD implant (and ablation) surgery
Time Frame: Admission for LVAD implant until hospital discharge (approximately 2-4 weeks)
Admission for LVAD implant until hospital discharge (approximately 2-4 weeks)
Mean duration of ablation
Time Frame: Admission for LVAD implant until hospital discharge (approximately 2-4 weeks)
Admission for LVAD implant until hospital discharge (approximately 2-4 weeks)
Mean rate of peri-procedural complication
Time Frame: Admission for LVAD implant until hospital discharge (approximately 2-4 weeks)
Peri-procedural complications include bleeding, infection, and need for repeat operation.
Admission for LVAD implant until hospital discharge (approximately 2-4 weeks)
Mean Length of stay in the intensive care unit after LVAD implant
Time Frame: Admission for LVAD implant until hospital discharge (approximately 2-4 weeks)
Admission for LVAD implant until hospital discharge (approximately 2-4 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Rochester

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

  • Principal Investigator: David Huang, MD, University of Rochester

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 27, 2022

Primary Completion (Estimated)

April 30, 2026

Study Completion (Estimated)

June 30, 2027

Study Registration Dates

First Submitted

August 29, 2021

First Submitted That Met QC Criteria

August 29, 2021

First Posted (Actual)

September 5, 2021

Study Record Updates

Last Update Posted (Actual)

March 23, 2026

Last Update Submitted That Met QC Criteria

March 19, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00006159
  • R01HL159401 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cardiomyopathies

Clinical Trials on Intra-Op Prophylactic VT ablation

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Benin

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe