Left atrial posterior wall isolation in conjunction with pulmonary vein isolation using cryoballoon for treatment of per
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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 1 & Deep K. Pujara 2 & Shelley L. Allen 1 & James H. Baker 3 & Martin A. Espinosa 3 & Eric F. Buch 4 & Uma Srivatsa 5 & Ethan Ellis 6 & Kevin Makati 7 & Marcin Kowalski 8 & Sung Lee 9 & Thomas Tadros 10 & Tina Baykaner 11 & Amin Al-Ahmad 12 & André d’Avila 13 & Luigi Di Biase 14 & Kaoru Okishige 15 & Andrea Natale 12 Received: 15 August 2020 / Accepted: 21 September 2020 # Springer Science+Business Media, LLC, part of Springer Nature 2020
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 doubleblind 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 postablation. 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. Keywords Catheter ablation . Cryoablation . Cryoballoon . Persistent atrial fibrillation . Posterior wall isolation
* Arash Aryana [email protected] 1
Cardiovascular Services, Mercy General Hospital and Dignity Health Heart and Vascular Institute, 3941 J Street, Suite #350, Sacramento, CA 95819, USA
8
Staten Island University Hospital, Staten Island, NY, USA
9
MedStar Georgetown University Hospital and Medical Center, Washington, DC, USA
10
Brigham and Women’s Hospital, Boston, MA, USA
11
Stanford University Medical Center, Stanford, CA, USA
12
Texas Cardiac Arrhythmia Inst
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