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

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ClinicalTrials.gov Identifier: NCT05034432
Recruitment Status : Recruiting
First Posted : September 5, 2021
Last Update Posted : July 5, 2022
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
David Huang, University of Rochester

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
Arrythmia Cardiomyopathies Procedure: Intra-Op Prophylactic VT ablation Other: Conventional Management Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Primary Completion Date : December 31, 2025
Estimated Study Completion Date : June 30, 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Arrhythmia

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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.

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

  5. 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) ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05034432


Contacts
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Contact: Ann Colasurdo 585-275-1054 ann_colasurdo@urmc.rochester.edu
Contact: Mary Brown 5852735283

Locations
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United States, New York
University of Rochester Recruiting
Rochester, New York, United States, 14642
Contact: Lori Caufield         
Principal Investigator: Igor Gosev         
Sponsors and Collaborators
University of Rochester
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
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Principal Investigator: David Huang, MD University of Rochester
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Responsible Party: David Huang, Professor, University of Rochester
ClinicalTrials.gov Identifier: NCT05034432    
Other Study ID Numbers: STUDY00006159
R01HL159401 ( U.S. NIH Grant/Contract )
First Posted: September 5, 2021    Key Record Dates
Last Update Posted: July 5, 2022
Last Verified: May 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cardiomyopathies
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes