Investigating VTA Ablation in Patients with Left Ventricular Assist Devices
Prophylactic Intra-Operative Ventricular Arrhythmia Ablation in High-Risk LVAD Candidates (PIVATAL)
This study is testing if a procedure to stop fast heartbeats during surgery for a heart pump can help patients with a history of those fast heartbeats feel better after the surgery.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Rochester Academic / other |
| Locations | 19 sites (Phoenix, Arizona and 18 other locations) |
| Trial ID | NCT05034432 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of ventricular tachycardia (VTA) ablation performed during the implantation of left ventricular assist devices (LVAD) in patients with a history of VTA. It is a multicenter, open-label, randomized-controlled trial enrolling 100 LVAD candidates who will be divided into two groups: one receiving intra-operative VTA ablation and the other receiving standard medical management. Comprehensive data on arrhythmia history and healthcare utilization will be collected, with participants followed for an average of 18 months post-surgery to assess outcomes related to arrhythmia and overall health. The study seeks to determine if VTA ablation can reduce the incidence of VTA after LVAD surgery.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with advanced cardiomyopathy eligible for LVAD and a history of sustained ventricular tachycardia or fibrillation.
Not a fit: Patients who have previously undergone successful VTA ablation without recurrent arrhythmias prior to LVAD implantation may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the occurrence of ventricular arrhythmias in patients undergoing LVAD implantation.
How similar studies have performed: While this specific approach is novel, similar studies have shown promise in managing arrhythmias in patients with advanced heart failure.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Phoenix, Arizona and 18 other locations
- Banner University Medical Center — Phoenix, Arizona, United States (Recruiting)
- UCLA Cardiac Arrthmia Center — Los Angeles, California, United States (Recruiting)
- University of California San Francisco — San Francisco, California, United States (Recruiting)
- Medstar Washington Hospital Center — Washington D.C., District of Columbia, United States (Recruiting)
- Piedmont Heart Institute — Atlanta, Georgia, United States (Recruiting)
- Emory University — Atlanta, Georgia, United States (Recruiting)
- Ascension St. Vincent Indianapolis — Indianapolis, Indiana, United States (Recruiting)
- Univedrsity of Louisville — Louisville, Kentucky, United States (Recruiting)
- Johns Hopkins University — Baltimore, Maryland, United States (Recruiting)
- Tufts Medical Center — Boston, Massachusetts, United States (Recruiting)
- Henry Ford Health — Detroit, Michigan, United States (Recruiting)
- Columbia University Medical Center — New York, New York, United States (Recruiting)
- University of Rochester — Rochester, New York, United States (Recruiting)
- Cleveland Clinic — Cleveland, Ohio, United States (Recruiting)
- University of Pennsylvania — Philadelphia, Pennsylvania, United States (Recruiting)
- Upmc — Pittsburgh, Pennsylvania, United States (Recruiting)
- Medical University of South Carolina — Charleston, South Carolina, United States (Recruiting)
- Vanderbilt University Medical Center — Nashville, Tennessee, United States (Recruiting)
- Houston Methodist Hospital — Houston, Texas, United States (Recruiting)
Study contacts
- Principal investigator: David Huang, MD — University of Rochester
- Study coordinator: Ann Colasurdo
- Email: ann_colasurdo@urmc.rochester.edu
- Phone: 585-275-1054
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.