Recruiting

VTA Ablation

Sponsor:

University of Rochester

Code:

NCT05034432

Conditions

Arrythmia

Cardiomyopathies

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Intra-Op Prophylactic VT ablation

Conventional Management

Study Details

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

Study ID

NCT05034432

Start date

May 27, 2022

Status verified date

Mar, 2026

Completion date

Jun 30, 2027

Anticipated

Primary completion date

Apr 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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

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

Interventions

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

Primary outcome measure

  • Recurrent VTA [ Time Frame: Post LVAD implant until end of follow-up, through study completion, an average of 18 months (minimum 6 months) ]

Central Contacts and Locations

Central contacts

Ann Colasurdo

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

Kathy Honsinger

585-273-1899

Locations

Banner University Medical Center

Recruiting

Phoenix, Arizona, United States, 85006

Contacts

Matt Freeman

623-293-3945mathew.freeman@bannerhealth.com

Principal Investigator:

Roderick Tung

UCLA Cardiac Arrthmia Center

Recruiting

Los Angeles, California, United States, 90095

Contacts

Julie Sorg

310-259-7327jsorg@mednet.ucla.edu

Principal Investigator:

Kalyanam Shivkumar

University of California San Francisco

Recruiting

San Francisco, California, United States, 94143

Contacts

Maria Eleni Varympopioti

415-910-5046mariaeleni.varympopioti@ucsf.edu

Principal Investigator:

Joshua Moss

Medstar Washington Hospital Center

Recruiting

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

Contacts

Jamie Guillergan

202-877-5902jamie.s.guillergan@medstar.net

Principal Investigator:

Keki Balsara

Piedmont Heart Institute

Recruiting

Atlanta, Georgia, United States, 30309

Contacts

Megan Kopp

404-605-5003megan.kopp@piedmont.org

Principal Investigator:

Ahmadreza Karimianpour

Emory University

Recruiting

Atlanta, Georgia, United States, 30322

Contacts

Jovita Brevard

404-712-5992jovita.johnson@emory.edu

Principal Investigator:

Anand Shah

Ascension St. Vincent Indianapolis

Recruiting

Indianapolis, Indiana, United States, 46260

Contacts

Regina Margiotti

317-338-6151regina.margiotti@ascension.org

Principal Investigator:

Sunit-Preet Chaudhry

Univedrsity of Louisville

Recruiting

Louisville, Kentucky, United States, 40202

Contacts

Julie Caswell

502-587-4177julie.caswell@louisville.edu

Principal Investigator:

Auras Ravi Atreya

Johns Hopkins University

Recruiting

Baltimore, Maryland, United States, 21287

Contacts

Zyriah Robinson

443-927-3983zyriah.robinson@jhmi.edu

Principal Investigator:

Chetan Pasrija

Tufts Medical Center

Recruiting

Boston, Massachusetts, United States, 02111

Contacts

Juan Carlos Collado Falcon

617-636-7433juan.carlos.collado.falcon@tuftsmedicine.org

Principal Investigator:

Guy Rozen

Henry Ford Health

Recruiting

Detroit, Michigan, United States, 48202

Contacts

Briita Wanhala

313-916-9575bwanhal1@hfhs.org

Principal Investigator:

Arfaat Khan

Columbia University Medical Center

Recruiting

New York, New York, United States, 10026

Contacts

Jessica Idumonyi

212-305-1429joi2102@cumc.columbia.edu

Principal Investigator:

Nir Uriel

University of Rochester

Recruiting

Rochester, New York, United States, 14642

Principal Investigator:

Sabu Thomas

Cleveland Clinic

Recruiting

Cleveland, Ohio, United States, 44195

Contacts

Raquel Rozich

216-444-4959

Principal Investigator:

Jakub Sroubek

University of Pennsylvania

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Mary Gnap

215-349-8446mary.gnap@pennmedicine.upenn.edu

Principal Investigator:

Greg Supple

UPMC

Recruiting

Pittsburgh, Pennsylvania, United States, 15213

Contacts

Rachel Mcgargle

412-864-0788mcgarglerd@upmc.edu

Principal Investigator:

Krishna Kancharla

Medical University of South Carolina

Recruiting

Charleston, South Carolina, United States, 29425

Contacts

Hannah Culpepper

843-792-7244culpepph@musc.edu

Principal Investigator:

Arman Kilic

Vanderbilt University Medical Center

Recruiting

Nashville, Tennessee, United States, 37232

Contacts

Lisa Slinger

615-385-2602lisa.slinger@vumc.org

Principal Investigator:

Sandip Zalawadiya

Houston Methodist Hospital

Recruiting

Houston, Texas, United States, 77030

Contacts

Chinwe Ngumezi

346-238-0290ccngumezi@houstonmethodist.org

Principal Investigator:

Nilesh Mathuria

More Information

Sponsor

University of Rochester

Last update posted

Jul 14, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by University of Rochester on 2026-07-14.