Left atrial posterior wall isolation in conjunction with pulmonary vein isolation using cryoballoon for treatment of persistent atrial fibrillation (PIVoTAL): study rationale and design

Arash Aryana, Deep K. Pujara, Shelley L. Allen, James H. Baker, Martin A. Espinosa, Eric F. Buch, Uma Srivatsa, Ethan Ellis, Kevin Makati, Marcin Kowalski, Sung Lee, Thomas Tadros, Tina Baykaner, Amin Al-Ahmad, André d’Avila, Luigi Di Biase, Kaoru Okishige, Andrea Natale

Research output: Contribution to journalArticlepeer-review

Abstract

Background: There is growing evidence in support of pulmonary vein isolation (PVI) with concomitant posterior wall isolation (PWI) for the treatment of patients with symptomatic persistent atrial fibrillation (persAF). However, there is limited data on the safety and efficacy of this approach using the cryoballoon. Objective: The aim of this multicenter, investigational device exemption trial (G190171) is to prospectively evaluate the acute and long-term outcomes of PVI versus PVI+PWI using the cryoballoon in patients with symptomatic persAF. Methods: The PIVoTAL is a prospective, randomized controlled study (ClinicalTrials.gov: NCT04505163) in which patients with symptomatic persAF refractory/intolerant to ≥ 1 class I–IV antiarrhythmic drug, undergoing first-time catheter ablation, will be randomized to PVI (n = 183) versus PVI+PWI (n = 183) using the cryoballoon in a 1:1 fashion. The design will be double-blind until randomization immediately after PVI, beyond which the design will transform into a single-blind. PVI using cryoballoon will be standardized using a pre-specified dosing algorithm. Other empiric ablations aside from documented arrhythmias/arrhythmias spontaneously induced during the procedure will not be permitted. The primary efficacy endpoint is defined as AF recurrence at 12 months, after a single procedure and a 90-day blanking period. Arrhythmia outcomes will be assessed by routine electrocardiograms and 7–14 day ambulatory electrocardiographic monitoring at 3, 6, and 12 months post-ablation. Conclusion: The PIVoTAL is a prospective, randomized controlled trial designed to evaluate the outcomes of PVI alone versus PVI+PWI using the cryoballoon, in patients with symptomatic persAF. We hypothesize that PVI+PWI will prove to be superior to PVI alone for prevention of AF recurrence.

Original languageEnglish (US)
JournalJournal of Interventional Cardiac Electrophysiology
DOIs
StateAccepted/In press - 2020

Keywords

  • Catheter ablation
  • Cryoablation
  • Cryoballoon
  • Persistent atrial fibrillation
  • Posterior wall isolation

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine
  • Physiology (medical)

Fingerprint Dive into the research topics of 'Left atrial posterior wall isolation in conjunction with pulmonary vein isolation using cryoballoon for treatment of persistent atrial fibrillation (PIVoTAL): study rationale and design'. Together they form a unique fingerprint.

Cite this