The PIVATAL Study -Study of Ventricular Arrhythmia (VTA) Ablation in Left Ventricular Assist Device (LVAD) Patients (PIVATAL)
Primary Purpose
Arrythmia, Cardiomyopathies
Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Intra-Op Prophylactic VT ablation
Conventional Management
Sponsored by
About this trial
This is an interventional treatment trial for Arrythmia
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
- 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
Sites / Locations
- University of RochesterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Intra-Op Prophylactic VT ablation
Conventional Management
Arm Description
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
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
Outcomes
Primary Outcome Measures
Recurrent VTA
Total VTA events, after accounting for the competing risk of death
Secondary Outcome Measures
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.
Mean duration of LVAD implant (and ablation) surgery
Mean duration of ablation
Mean rate of peri-procedural complication
Peri-procedural complications include bleeding, infection, and need for repeat operation.
Mean Length of stay in the intensive care unit after LVAD implant
Full Information
NCT ID
NCT05034432
First Posted
August 29, 2021
Last Updated
July 5, 2023
Sponsor
University of Rochester
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
1. Study Identification
Unique Protocol Identification Number
NCT05034432
Brief Title
The PIVATAL Study -Study of Ventricular Arrhythmia (VTA) Ablation in Left Ventricular Assist Device (LVAD) Patients
Acronym
PIVATAL
Official Title
Prophylactic Intra-Operative Ventricular Arrhythmia Ablation in High-Risk LVAD Candidates (PIVATAL)
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 27, 2022 (Actual)
Primary Completion Date
December 31, 2025 (Anticipated)
Study Completion Date
June 30, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Rochester
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arrythmia, Cardiomyopathies
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intra-Op Prophylactic VT ablation
Arm Type
Experimental
Arm Description
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
Arm Title
Conventional Management
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Procedure
Intervention Name(s)
Intra-Op Prophylactic VT ablation
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Conventional Management
Intervention Description
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 Information:
Title
Recurrent VTA
Description
Total VTA events, after accounting for the competing risk of death
Time Frame
Post LVAD implant until end of follow-up, through study completion, an average of 18 months (minimum 6 months)
Secondary Outcome Measure Information:
Title
Number of participants with treatment-related adverse events as assessed by medical records for hospitalization, stroke and heart failure.
Description
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.
Time Frame
Post LVAD implant until end of follow-up, approximately 18 months
Title
Mean duration of LVAD implant (and ablation) surgery
Time Frame
Admission for LVAD implant until hospital discharge (approximately 2-4 weeks)
Title
Mean duration of ablation
Time Frame
Admission for LVAD implant until hospital discharge (approximately 2-4 weeks)
Title
Mean rate of peri-procedural complication
Description
Peri-procedural complications include bleeding, infection, and need for repeat operation.
Time Frame
Admission for LVAD implant until hospital discharge (approximately 2-4 weeks)
Title
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)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ann Colasurdo
Phone
585-275-1054
Email
ann_colasurdo@urmc.rochester.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Mary Brown
Phone
5852735283
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Huang, MD
Organizational Affiliation
University of Rochester
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Rochester
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lori Caufield
First Name & Middle Initial & Last Name & Degree
Igor Gosev
12. IPD Sharing Statement
Learn more about this trial
The PIVATAL Study -Study of Ventricular Arrhythmia (VTA) Ablation in Left Ventricular Assist Device (LVAD) Patients
We'll reach out to this number within 24 hrs