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

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 t...

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Veröffentlicht in:Journal of interventional cardiac electrophysiology 2021-10, Vol.62 (1), p.187-198
Hauptverfasser: Aryana, Arash, Pujara, Deep K., Allen, Shelley L., Baker, James H., Espinosa, Martin A., Buch, Eric F., Srivatsa, Uma, Ellis, Ethan, Makati, Kevin, Kowalski, Marcin, Lee, Sung, Tadros, Thomas, Baykaner, Tina, Al-Ahmad, Amin, d’Avila, André, Di Biase, Luigi, Okishige, Kaoru, Natale, Andrea
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container_end_page 198
container_issue 1
container_start_page 187
container_title Journal of interventional cardiac electrophysiology
container_volume 62
creator Aryana, Arash
Pujara, Deep K.
Allen, Shelley L.
Baker, James H.
Espinosa, Martin A.
Buch, Eric F.
Srivatsa, Uma
Ellis, Ethan
Makati, Kevin
Kowalski, Marcin
Lee, Sung
Tadros, Thomas
Baykaner, Tina
Al-Ahmad, Amin
d’Avila, André
Di Biase, Luigi
Okishige, Kaoru
Natale, Andrea
description 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.
doi_str_mv 10.1007/s10840-020-00885-w
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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. 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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. 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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.</abstract><cop>New York</cop><pub>Springer US</pub><pmid>33009645</pmid><doi>10.1007/s10840-020-00885-w</doi><tpages>12</tpages><oa>free_for_read</oa></addata></record>
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subjects Ablation
Algorithms
Arrhythmia
Atrial Fibrillation - diagnostic imaging
Atrial Fibrillation - surgery
Blanking
Cardiac arrhythmia
Cardiology
Catheter Ablation
Catheters
Cryosurgery
Design
Electrocardiography
Evaluation
Fibrillation
Humans
Medical instruments
Medicine
Medicine & Public Health
Patients
Prospective Studies
Pulmonary Veins - diagnostic imaging
Pulmonary Veins - surgery
Randomization
Recurrence
Single-Blind Method
Treatment Outcome
title Left atrial posterior wall isolation in conjunction with pulmonary vein isolation using cryoballoon for treatment of persistent atrial fibrillation (PIVoTAL): study rationale and design
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