Prophylactic Intra-Operative Ventricular Arrhythmia Ablation in High-Risk LVAD Candidates (PIVATAL)
Status: Recruiting
Location: See all (19) locations...
Intervention Type: Other, Procedure
Study Type: Interventional
Study Phase: Phase 4
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
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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.
Locations
United States
Arizona
Banner University Medical Center
RECRUITING
Phoenix
California
UCLA Cardiac Arrthmia Center
RECRUITING
Los Angeles
University of California San Francisco
RECRUITING
San Francisco
Washington, D.c.
Medstar Washington Hospital Center
RECRUITING
Washington D.c.
Georgia
Emory University
RECRUITING
Atlanta
Piedmont Heart Institute
RECRUITING
Atlanta
Indiana
Ascension St. Vincent Indianapolis
RECRUITING
Indianapolis
Kentucky
Univedrsity of Louisville
RECRUITING
Louisville
Massachusetts
Tufts Medical Center
RECRUITING
Boston
Maryland
Johns Hopkins University
RECRUITING
Baltimore
Michigan
Henry Ford Health
RECRUITING
Detroit
New York
Columbia University Medical Center
RECRUITING
New York
University of Rochester
RECRUITING
Rochester
Ohio
Cleveland Clinic
RECRUITING
Cleveland
Pennsylvania
University of Pennsylvania
RECRUITING
Philadelphia
UPMC
RECRUITING
Pittsburgh
South Carolina
Medical University of South Carolina
RECRUITING
Charleston
Tennessee
Vanderbilt University Medical Center
RECRUITING
Nashville
Texas
Houston Methodist Hospital
RECRUITING
Houston
Contact Information
Primary
Ann Colasurdo
ann_colasurdo@urmc.rochester.edu
585-275-1054
Backup
Kathy Honsinger
585-273-1899
Time Frame
Start Date: 2022-05-27
Estimated Completion Date: 2027-06-30
Participants
Target number of participants: 100
Treatments
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
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
Authors
Mehmet W Aktas, Igor Gosev
Related Therapeutic Areas
Sponsors
Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
Leads: University of Rochester