The main objective of this study is to prospectively evaluate the effect of prophylactic intra-operative ventricular tachyarrhythmia ablation (VTA) at the time of left ventricular assist device (LVAD) implantation on post-implant total recurrent VTA events, after accounting for the competing risk of death, from discharge to an average follow-up of 18 months (with a minimum of 9 months) after LVAD implantation.
PIVATAL
Prophylactic Intra-Operative Ventricular Arrhythmia Ablation in High-Risk LVAD Candidates
Atrial fibrillation, Heart failure
All genders
18+
Recruiting now
Overview
Principal Investigator: Guy Rozen, MD
Contact Us
Nadia Bokhari
Study details
Inclusion Criteria
- Presence of advanced cardiomyopathy (of all INTERMACS classification) and eligible for LVAD implant per the decision of the Heart Failure clinical team
- ICD any time in the past with remote monitoring
- History of treated or monitored sustained (i.e. >30 seconds in duration) ventricular tachyarrhythmia or ventricular fibrillation episode eithin the past 5 years
Exclusion Criteria
- Past successful ventricular tachyarrhythmia ablation without recurrent ventricular tacchyarrhythmai prior to LVAD implant
- Participation in other clinical trials (observational registries are allowed with approval)
- Unable or unwilling to provide informed consent
Study Requirements
Subject participation may last up to about 24 months. When enrolled in the study, participants will be randomized to one of two groups, intervention arm or control arm. All participants will have a baseline visit consisting of medical history and ICD interrogation data collection. During the first visit, potential eligible subjects for LVAD implantation will be consented and a baseline QoL assessment will be performed before the LVAD procedure. All subjects will follow standard of care 3 month visits, during which data on VTA events, ICD therapy, medication lists, and adverse events will be collected. Ramp testing with an echocardiogram will be performed at 6 months per standard of care. ICD data will be collected with every subject report of ICD therapy, clinic visit, adverse events, emergency room visits, and hospitalizations. For the control group, a standardized antiarrhythmic therapy is recommended. For the intervention group, subjects will undergo a prophylactic VTA ablation. Subjects who undergo an intra-operative VTA ablation should continue on their stable regime of antiarrhythmic medical therapy.