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

Sponsor
University of Rochester (Other)
Overall Status
Recruiting
CT.gov ID
NCT05034432
Collaborator
National Heart, Lung, and Blood Institute (NHLBI) (NIH)
100
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2
49.1
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Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Procedure: Intra-Op Prophylactic VT ablation
  • Other: Conventional Management
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Prophylactic Intra-Operative Ventricular Arrhythmia Ablation in High-Risk LVAD Candidates (PIVATAL)
Actual Study Start Date :
May 27, 2022
Anticipated Primary Completion Date :
Dec 31, 2025
Anticipated Study Completion Date :
Jun 30, 2026

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Recurrent VTA [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

Secondary Outcome Measures

  1. 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]

    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.

  2. Mean duration of LVAD implant (and ablation) surgery [Admission for LVAD implant until hospital discharge (approximately 2-4 weeks)]

  3. Mean duration of ablation [Admission for LVAD implant until hospital discharge (approximately 2-4 weeks)]

  4. Mean rate of peri-procedural complication [Admission for LVAD implant until hospital discharge (approximately 2-4 weeks)]

    Peri-procedural complications include bleeding, infection, and need for repeat operation.

  5. Mean Length of stay in the intensive care unit after LVAD implant [Admission for LVAD implant until hospital discharge (approximately 2-4 weeks)]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

  • 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Rochester Rochester New York United States 14642

Sponsors and Collaborators

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

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
David Huang, Professor, University of Rochester
ClinicalTrials.gov Identifier:
NCT05034432
Other Study ID Numbers:
  • STUDY00006159
  • R01HL159401
First Posted:
Sep 5, 2021
Last Update Posted:
Jul 5, 2022
Last Verified:
May 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 5, 2022