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

ClinicalTrials.gov ID

NCT05034432

Lead Sponsor

University of RochesterOTHER

Overall Status

Recruiting

Study Type

Interventional

Phase

Phase 4

Enrollment

100Estimated

Last Update Posted

Jul 14, 2026Actual

Start Date

May 27, 2022Actual

Primary Completion Date

Apr 30, 2027Estimated

Completion Date

Jun 30, 2027Estimated

Official Title

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

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

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.

• Arrythmia
• Cardiomyopathies

• Intra-Op Prophylactic VT ablation
• Conventional Management

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

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

Primary Purpose

Treatment

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

Single

Lead Sponsor

University of RochesterOTHER

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)NIH

megan.kopp@piedmont.org404-605-5003

jovita.johnson@emory.edu404-712-5992

bwanhal1@hfhs.org313-916-9575

216-444-4959

mcgarglerd@upmc.edu412-864-0788

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