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

Cardiomyopathies Clinical Trial

— PIVATAL  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05034432
• Other study ID #: STUDY00006159
• Secondary ID: R01HL159401
• Status: Recruiting
• Phase: Phase 4
• Start date: May 27, 2022
• Est. completion date: June 30, 2026

Study information

• Verified date: July 2023
• Source: University of Rochester
• Contact: Ann Colasurdo
• Phone: 585-275-1054
• Email: ann_colasurdo[@]urmc.rochester.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: June 30, 2026
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arrhythmias, Cardiac
• Arrythmia
• Cardiomyopathies

Intervention

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

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

Locations

Country	Name	City	State
United States	University of Rochester	Rochester	New York

Sponsors (2)

Lead Sponsor	Collaborator
University of Rochester	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number of participants with treatment-related adverse events as assessed by medical records for hospitalization, stroke and heart failure.	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
Secondary	Mean duration of LVAD implant (and ablation) surgery		Admission for LVAD implant until hospital discharge (approximately 2-4 weeks)
Secondary	Mean duration of ablation		Admission for LVAD implant until hospital discharge (approximately 2-4 weeks)
Secondary	Mean rate of peri-procedural complication	Peri-procedural complications include bleeding, infection, and need for repeat operation.	Admission for LVAD implant until hospital discharge (approximately 2-4 weeks)
Secondary	Mean Length of stay in the intensive care unit after LVAD implant		Admission for LVAD implant until hospital discharge (approximately 2-4 weeks)