Design and characteristics of the prophylactic intra-operative ventricular arrhythmia ablation in high-risk LVAD candidates (PIVATAL) trial

David T. Huang*, Igor Gosev, Katherine L. Wood, Hima Vidula, William Stevenson, Frank Marchlinski, Gregory Supple, Sandip K. Zalawadiya, J. Peter Weiss, Roderick Tung, Wendy S. Tzou, Joshua D. Moss, Krishna Kancharla, Sunit Preet Chaudhry, Parin J. Patel, Arfaat M. Khan, Claudio Schuger, Guy Rozen, Michael S. Kiernan, Gregory S. CouperMarzia Leacche, Ezequiel J. Molina, Anand D. Shah, Michael Lloyd, Jakub Sroubek, Edward Soltesz, Kalyanam Shivkumar, Casey White, Sinan Tankut, Brent A. Johnson, Scott McNitt, Valentina Kutyifa, Wojciech Zareba, Ilan Goldenberg

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review


Background: The use of a Left Ventricular Assist Device (LVAD) in patients with advanced heart failure refractory to optimal medical management has progressed steadily over the past two decades. Data have demonstrated reduced LVAD efficacy, worse clinical outcome, and higher mortality for patients who experience significant ventricular tachyarrhythmia (VTA). We hypothesize that a novel prophylactic intra-operative VTA ablation protocol at the time of LVAD implantation may reduce the recurrent VTA and adverse events postimplant. Methods: We designed a prospective, multicenter, open-label, randomized-controlled clinical trial enrolling 100 patients who are LVAD candidates with a history of VTA in the previous 5 years. Enrolled patients will be randomized in a 1:1 fashion to intra-operative VTA ablation (n = 50) versus conventional medical management (n = 50) with LVAD implant. Arrhythmia outcomes data will be captured by an implantable cardioverter defibrillator (ICD) to monitor VTA events, with a uniform ICD programming protocol. Patients will be followed prospectively over a mean of 18 months (with a minimum of 9 months) after LVAD implantation to evaluate recurrent VTA, adverse events, and procedural outcomes. Secondary endpoints include right heart function/hemodynamics, healthcare utilization, and quality of life. Conclusion: The primary aim of this first-ever randomized trial is to assess the efficacy of intra-operative ablation during LVAD surgery in reducing VTA recurrence and improving clinical outcomes for patients with a history of VTA.

Original languageEnglish
Article numbere13073
JournalAnnals of Noninvasive Electrocardiology
Issue number5
StatePublished - Sep 2023
Externally publishedYes


  • ablation
  • left ventricular assist device
  • ventricular tachycardia


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