Cryoballoon PVI With PWI Versus PVI Alone In Patients With PAF
NCT ID: NCT05296824
Last Updated: 2025-11-05
Study Results
Results available
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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Recruitment Status
COMPLETED
Total Enrollment
320 participants
Study Classification
OBSERVATIONAL
Study Start Date
2014-01-01
Study Completion Date
2021-12-31
Brief Summary
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Cryoballoon ablation has emerged as a safe and effective strategy for treatment of atrial fibrillation (AF) for which it has recently received a 'first-line' therapy indication by the FDA. Pulmonary vein (PV) isolation (PVI) has been the cornerstone of this procedure achieving freedom from recurrent AF in up to \~80% of patients at 12 months of follow-up. However, the success has been shown to be significantly lower, in the range of 50-60% at 3-5 years of follow-up. Other more recent cryoballoon ablation studies have demonstrated marked improvements in clinical outcomes associated with concomitant PVI and cryoballoon ablation/isolation of the 'PV component' (a region of the left atrial posterior \[back\] wall lying between the PVs that is anatomically and embryologically related to the PVs), versus PVI alone in patients with persistent AF.
PVI+PWI using cryoballoon ablation has been widely-practiced in patients with paroxysmal AF. However, the acute/long-term safety and efficacy of this approach has not been formally investigated in paroxysmal AF. Given the mechanistic similarities between persistent and paroxysmal AF, the investigators hypothesize that similar benefits associated with PVI+PWI may also be observed in those with paroxysmal AF. Yet, due to the relative infrequency of breakthrough/recurrent arrhythmias in patients with PAF, to detect a significant difference, large sample sizes and extended follow-up (\>24 months) are likely needed. Hence, the aim of this retrospective, observational study is to examine the acute and long-term efficacy and safety beyond 36 months of follow-up associated with PVI alone versus PVI+PWI using cryoballoon ablation in a large cohort of patients with PAF, performed by a single operator between 1/1/2014 and 8/31/2018 at Mercy General Hospital.
PVI+PWI using cryoballoon ablation has been widely-practiced in patients with paroxysmal AF. However, the acute/long-term safety and efficacy of this approach has not been formally investigated in paroxysmal AF. Given the mechanistic similarities between persistent and paroxysmal AF, the investigators hypothesize that similar benefits associated with PVI+PWI may also be observed in those with paroxysmal AF. Yet, due to the relative infrequency of breakthrough/recurrent arrhythmias in patients with PAF, to detect a significant difference, large sample sizes and extended follow-up (\>24 months) are likely needed. Hence, the aim of this retrospective, observational study is to examine the acute and long-term efficacy and safety beyond 36 months of follow-up associated with PVI alone versus PVI+PWI using cryoballoon ablation in a large cohort of patients with PAF, performed by a single operator between 1/1/2014 and 8/31/2018 at Mercy General Hospital.
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Detailed Description
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INTRODUCTION AND RATIONALE Cryoballoon ablation has emerged as a safe and effective strategy for the treatment of atrial fibrillation (AF), and based on growing evidence, it recently received an initial rhythm control strategy ('first-line' therapy) indication by the Food and Drug Administration. Pulmonary vein (PV) isolation (PVI) guided typically by cryoballoon PV occlusion remains the cornerstone of cryoballoon ablation. Although single-procedure freedom from recurrent AF following such an approach has been reported to be as high as 82% at 12 months, the success appears to be markedly diminished in the range of 50-60% during long-term follow-up. This in part may be related to the inherent limitations of cryoballoon ablation which often yields an ostial (distal) level PVI. Along these lines, prior investigations have found wide-area antral PVI encompassing the PV component (i.e., the region of the posterior wall lying between the PVs) to be superior to ostial PVI. Other more recent studies involving the cryoballoon have demonstrated marked improvements in clinical efficacy associated with concomitant PVI and posterior wall isolation (PWI) within the region of the PV component as compared to PVI alone, in patients with persistent AF. Though widely-practiced, this approach has not been formally investigated in patients with symptomatic paroxysmal AF (PAF). Given the mechanistic similarities between persistent and PAF, the investigators hypothesize that similar benefits may also be observed with PVI+PWI in the patients with PAF. Yet, given the relative infrequency of breakthrough/recurrent arrhythmias in patients with PAF, to detect a significant difference, large sample sizes and extended follow-up (\>24 months) are likely needed. Hence, the aim of this retrospective, observational study is to examine the clinical efficacy and safety of PVI alone versus PVI+PWI using cryoballoon ablation, in a large cohort of patients with symptomatic PAF beyond 36 months of follow-up.
EMBRYOLOGIC EVIDENCE The PV component of the posterior left atrial wall shares a common primordial origin with the PVs. The embryologic origin of the four PVs and the PV component can be traced back to the mediastinal myocardium derived from a mid-pharyngeal strand at 6 weeks of gestation. Early on during development, a single primitive vein returns blood from the lungs to the common trabeculated atrium. As the interatrial septum forms, the single vein divides twice to give rise to the four PVs. As the PV ostia migrate away from one another, the smooth tissue of the posterior left atrial wall forms. Although this region is anatomically contiguous with the surrounding trabeculated tissue from the primitive left atrium, its embryologic origin results in electrophysiologic properties that are more similar to the muscular PV sleeves than the immediately adjacent atrial roof or floor ('true' posterior wall).
During embryogenesis, the single vein and its surrounding tissue (in addition to the Bachmann's bundle and sinus venosus-derived structures) demonstrate the expression of genes responsible for development of cardiac conduction system. Although expression of these genes decreases during embryogenesis, it is hypothesized that their continued low-level expression may explain why certain regions within the atria are more commonly the site of origin of focal ectopy. These embryologic characteristics would certainly explain the well-accepted clinical observation that AF is frequently initiated by ectopic beats arising from the PVs and the increasingly reported observation that ectopic beats from the left atrial posterior wall can similarly initiate AF.
ANATOMIC EVIDENCE A visual examination of the PV component and the orientation of its myofibrils suggests direct continuity between this region and the PV antra as does a gross anatomical assessment of certain left atrial morphologies. Meanwhile, underneath the smooth endocardial surface of the PV component, numerous subendocardial and subepicardial muscular bundles traverse with varying fiber orientation. Fibers immediately surrounding the PVs typically encircle the veins, whereas those in the subepicardial aspect of the posterior wall are comprised of the septo-pulmonary bundle and display a more vertical or oblique orientation. Immediately adjacent to the lateral aspect of the septo-pulmonary bundle are found transversely oriented fibers which extend to the left PV ostia. It is this change in orientation that is believed to promote anisotropic conduction and therefore reentry.
Prior investigators have found that in patients with PAF, this juxtaposition of fiber orientations was associated with isochronal crowding and functional block depending on the direction of wave front propagation during sinus or paced rhythm. Similarly, mapping of fibrillatory waves during cardiac surgery in patients with AF has revealed simultaneous propagation of longitudinally dissociated fibrillation waves which are separated by continuously changing lines of block. These lines of block are once again most densely packed in the PV component, leading to the highest degree of block and dissociation and the lowest incidence of wave front boundaries formed by collision.
ELECTROPHYSIOLOGIC EVIDENCE As discussed, the PV component is derived from tissues other than the primitive cardiac tube. Hence, the PV component is believed to be related more to PV versus atrial tissue. Some studies have suggested that these tissues share more in common with the sinoatrial nodal myocytes, displaying higher diastolic calcium contents and propensity to spontaneous depolarization. Furthermore, the PV component exhibits increased conduction abnormalities, a higher incidence of delayed after depolarizations and larger late sodium and intracellular and sarcoplasmic reticulum Ca++ contents, but a smaller inward rectifier potassium currents and a reduced resting membrane potential. The posterior wall and the PV myocytes are also characterized by shorter action potential durations and slower phase 0 upstroke velocities. As such, the PV component is believed to be the site of collision of activation wave fronts as they sweep across the left atrial dome. Along these lines, prior Investigators have found this region of the left atrium to be responsible for 80% of high-frequency rotors in an isolated sheep heart model. Similarly, mapping in humans often localizes stable rotors or focal sources as well as complex fractionated electrograms in the posterior wall and the left atrial roof. The PV component has in fact been shown to be a common source of triggers accounting for up to \~40% of non-PV triggers in patients with AF.
Lastly, the PV component is also the site of the main autonomic ganglionic plexi related to the left atrial dome (i.e., the superior left atrial ganglionated plexus) which is believed to modulate extrinsic cardiac innervation and facilitate the occurrence of AF in a hyperactive autonomic state. As such, it is believed that catheter ablation of the PV component also greatly attenuates the input of these plexi to the PVs, interrupting the vagosympathetic input to the ligament of Marshall and the inferior left ganglionated plexus which have been highly implicated in the pathogenesis of AF.
EMBRYOLOGIC EVIDENCE The PV component of the posterior left atrial wall shares a common primordial origin with the PVs. The embryologic origin of the four PVs and the PV component can be traced back to the mediastinal myocardium derived from a mid-pharyngeal strand at 6 weeks of gestation. Early on during development, a single primitive vein returns blood from the lungs to the common trabeculated atrium. As the interatrial septum forms, the single vein divides twice to give rise to the four PVs. As the PV ostia migrate away from one another, the smooth tissue of the posterior left atrial wall forms. Although this region is anatomically contiguous with the surrounding trabeculated tissue from the primitive left atrium, its embryologic origin results in electrophysiologic properties that are more similar to the muscular PV sleeves than the immediately adjacent atrial roof or floor ('true' posterior wall).
During embryogenesis, the single vein and its surrounding tissue (in addition to the Bachmann's bundle and sinus venosus-derived structures) demonstrate the expression of genes responsible for development of cardiac conduction system. Although expression of these genes decreases during embryogenesis, it is hypothesized that their continued low-level expression may explain why certain regions within the atria are more commonly the site of origin of focal ectopy. These embryologic characteristics would certainly explain the well-accepted clinical observation that AF is frequently initiated by ectopic beats arising from the PVs and the increasingly reported observation that ectopic beats from the left atrial posterior wall can similarly initiate AF.
ANATOMIC EVIDENCE A visual examination of the PV component and the orientation of its myofibrils suggests direct continuity between this region and the PV antra as does a gross anatomical assessment of certain left atrial morphologies. Meanwhile, underneath the smooth endocardial surface of the PV component, numerous subendocardial and subepicardial muscular bundles traverse with varying fiber orientation. Fibers immediately surrounding the PVs typically encircle the veins, whereas those in the subepicardial aspect of the posterior wall are comprised of the septo-pulmonary bundle and display a more vertical or oblique orientation. Immediately adjacent to the lateral aspect of the septo-pulmonary bundle are found transversely oriented fibers which extend to the left PV ostia. It is this change in orientation that is believed to promote anisotropic conduction and therefore reentry.
Prior investigators have found that in patients with PAF, this juxtaposition of fiber orientations was associated with isochronal crowding and functional block depending on the direction of wave front propagation during sinus or paced rhythm. Similarly, mapping of fibrillatory waves during cardiac surgery in patients with AF has revealed simultaneous propagation of longitudinally dissociated fibrillation waves which are separated by continuously changing lines of block. These lines of block are once again most densely packed in the PV component, leading to the highest degree of block and dissociation and the lowest incidence of wave front boundaries formed by collision.
ELECTROPHYSIOLOGIC EVIDENCE As discussed, the PV component is derived from tissues other than the primitive cardiac tube. Hence, the PV component is believed to be related more to PV versus atrial tissue. Some studies have suggested that these tissues share more in common with the sinoatrial nodal myocytes, displaying higher diastolic calcium contents and propensity to spontaneous depolarization. Furthermore, the PV component exhibits increased conduction abnormalities, a higher incidence of delayed after depolarizations and larger late sodium and intracellular and sarcoplasmic reticulum Ca++ contents, but a smaller inward rectifier potassium currents and a reduced resting membrane potential. The posterior wall and the PV myocytes are also characterized by shorter action potential durations and slower phase 0 upstroke velocities. As such, the PV component is believed to be the site of collision of activation wave fronts as they sweep across the left atrial dome. Along these lines, prior Investigators have found this region of the left atrium to be responsible for 80% of high-frequency rotors in an isolated sheep heart model. Similarly, mapping in humans often localizes stable rotors or focal sources as well as complex fractionated electrograms in the posterior wall and the left atrial roof. The PV component has in fact been shown to be a common source of triggers accounting for up to \~40% of non-PV triggers in patients with AF.
Lastly, the PV component is also the site of the main autonomic ganglionic plexi related to the left atrial dome (i.e., the superior left atrial ganglionated plexus) which is believed to modulate extrinsic cardiac innervation and facilitate the occurrence of AF in a hyperactive autonomic state. As such, it is believed that catheter ablation of the PV component also greatly attenuates the input of these plexi to the PVs, interrupting the vagosympathetic input to the ligament of Marshall and the inferior left ganglionated plexus which have been highly implicated in the pathogenesis of AF.
Conditions
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Paroxysmal Atrial Fibrillation
Study Design
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Observational Model Type
CASE_ONLY
Study Time Perspective
RETROSPECTIVE
Study Groups
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Pulmonary vein isolation (PVI) only
Patients with symptomatic paroxysmal atrial fibrillation who received cryoballoon pulmonary vein isolation (PVI) only
Cryoballoon ablation for the treatment of atrial fibrillation
Intervention Type
PROCEDURE
Cryoballoon ablation for the treatment of atrial fibrillation
Pulmonary vein isolation (PVI) with posterior wall isolation (PWI)
Patients with symptomatic paroxysmal atrial fibrillation who received cryoballoon pulmonary vein isolation (PVI) with posterior wall isolation (PWI)
Cryoballoon ablation for the treatment of atrial fibrillation
Intervention Type
PROCEDURE
Cryoballoon ablation for the treatment of atrial fibrillation
Interventions
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Cryoballoon ablation for the treatment of atrial fibrillation
Cryoballoon ablation for the treatment of atrial fibrillation
Intervention Type
PROCEDURE
Eligibility Criteria
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Inclusion Criteria
* Age 18 years or older
* Cryoballoon PVI+PWI
* Cryoballoon PVI alone
* Symptomatic paroxysmal atrial fibrillation
* Cryoballoon PVI+PWI
* Cryoballoon PVI alone
* Symptomatic paroxysmal atrial fibrillation
Exclusion Criteria
* None
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
Yes
Sponsors
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Mercy General Hospital and Dignity Health Heart and Vascular Institute
UNKNOWN
Sponsor Role
collaborator
UC Health Medical Center
UNKNOWN
Sponsor Role
collaborator
The University of Texas Health Science Center, Houston
OTHER
Sponsor Role
collaborator
Beth Israel Deaconess Medical Center
OTHER
Sponsor Role
collaborator
Sacramento EP Research
OTHER
Sponsor Role
lead
Responsible Party
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Arash Aryana, MD
Director, Greater Sacramento Cardiovascular Service Line
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Arash Aryana, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Mercy General Hospital and Dignity Health Heart and Vascular Institute
Locations
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Mercy General Hospital and Dignity Health Heart and Vascular Institute
Sacramento, California, United States
Site Status
UC Health Medical Center
Loveland, Colorado, United States
Site Status
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Site Status
University of Texas Health Science Center at Houston
Houston, Texas, United States
Site Status
Countries
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United States
References
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BACKGROUND
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BACKGROUND
Bisignani A, Overeinder I, Kazawa S, Iacopino S, Cecchini F, Miraglia V, Osorio TG, Boveda S, Bala G, Mugnai G, Monaco C, Stroker E, Brugada P, Sieira J, Galli A, de Asmundis C, Chierchia GB. Posterior box isolation as an adjunctive ablation strategy with the second-generation cryoballoon for paroxysmal atrial fibrillation: a comparison with standard cryoballoon pulmonary vein isolation. J Interv Card Electrophysiol. 2021 Aug;61(2):313-319. doi: 10.1007/s10840-020-00812-z. Epub 2020 Jul 6.
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BACKGROUND
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BACKGROUND
Elbatran AI, Anderson RH, Mori S, Saba MM. The rationale for isolation of the left atrial pulmonary venous component to control atrial fibrillation: A review article. Heart Rhythm. 2019 Sep;16(9):1392-1398. doi: 10.1016/j.hrthm.2019.03.012. Epub 2019 Mar 16.
Reference Type
BACKGROUND
Clarke JD, Piccini JP, Friedman DJ. The role of posterior wall isolation in catheter ablation of persistent atrial fibrillation. J Cardiovasc Electrophysiol. 2021 Sep;32(9):2567-2576. doi: 10.1111/jce.15164. Epub 2021 Jul 21.
Reference Type
BACKGROUND
Aryana A, Su W, Kuniss M, Okishige K, de Asmundis C, Tondo C, Chierchia GB. Segmental nonocclusive cryoballoon ablation of pulmonary veins and extrapulmonary vein structures: Best practices III. Heart Rhythm. 2021 Aug;18(8):1435-1444. doi: 10.1016/j.hrthm.2021.04.020. Epub 2021 Apr 24.
Reference Type
BACKGROUND
Aryana A, Kenigsberg DN, Kowalski M, Koo CH, Lim HW, O'Neill PG, Bowers MR, Hokanson RB, Ellenbogen KA; Cryo-DOSING Investigators. Verification of a novel atrial fibrillation cryoablation dosing algorithm guided by time-to-pulmonary vein isolation: Results from the Cryo-DOSING Study (Cryoballoon-ablation DOSING Based on the Assessment of Time-to-Effect and Pulmonary Vein Isolation Guidance). Heart Rhythm. 2017 Sep;14(9):1319-1325. doi: 10.1016/j.hrthm.2017.06.020. Epub 2017 Jun 15.
Reference Type
BACKGROUND
Kis Z, Muka T, Franco OH, Bramer WM, De Vries LJ, Kardos A, Szili-Torok T. The Short and Long-Term Efficacy of Pulmonary Vein Isolation as a Sole Treatment Strategy for Paroxysmal Atrial Fibrillation: A Systematic Review and Meta-Analysis. Curr Cardiol Rev. 2017;13(3):199-208. doi: 10.2174/1573403X13666170117125124.
Reference Type
BACKGROUND
Reddy VY, Neuzil P, d'Avila A, Laragy M, Malchano ZJ, Kralovec S, Kim SJ, Ruskin JN. Balloon catheter ablation to treat paroxysmal atrial fibrillation: what is the level of pulmonary venous isolation? Heart Rhythm. 2008 Mar;5(3):353-60. doi: 10.1016/j.hrthm.2007.11.006. Epub 2007 Nov 7.
Reference Type
BACKGROUND
Mesquita J, Cavaco D, Ferreira AM, Costa FM, Carmo P, Morgado F, Mendes M, Adragao P. Very long-term outcomes after a single catheter ablation procedure for the treatment of atrial fibrillation-the protective role of antiarrhythmic drug therapy. J Interv Card Electrophysiol. 2018 Jun;52(1):39-45. doi: 10.1007/s10840-018-0340-4. Epub 2018 Mar 6.
Reference Type
BACKGROUND
McLellan AJ, Ling LH, Azzopardi S, Lee GA, Lee G, Kumar S, Wong MC, Walters TE, Lee JM, Looi KL, Halloran K, Stiles MK, Lever NA, Fynn SP, Heck PM, Sanders P, Morton JB, Kalman JM, Kistler PM. A minimal or maximal ablation strategy to achieve pulmonary vein isolation for paroxysmal atrial fibrillation: a prospective multi-centre randomized controlled trial (the Minimax study). Eur Heart J. 2015 Jul 21;36(28):1812-21. doi: 10.1093/eurheartj/ehv139. Epub 2015 Apr 28.
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BACKGROUND
Reissmann B, Budelmann T, Wissner E, Schluter M, Heeger CH, Mathew S, Maurer T, Lemes C, Fink T, Rillig A, Santoro F, Riedl J, Ouyang F, Kuck KH, Metzner A. Five-year clinical outcomes of visually guided laser balloon pulmonary vein isolation for the treatment of paroxysmal atrial fibrillation. Clin Res Cardiol. 2018 May;107(5):405-412. doi: 10.1007/s00392-017-1199-6. Epub 2017 Dec 28.
Reference Type
BACKGROUND
Mun HS, Joung B, Shim J, Hwang HJ, Kim JY, Lee MH, Pak HN. Does additional linear ablation after circumferential pulmonary vein isolation improve clinical outcome in patients with paroxysmal atrial fibrillation? Prospective randomised study. Heart. 2012 Mar;98(6):480-4. doi: 10.1136/heartjnl-2011-301107. Epub 2012 Jan 27.
Reference Type
BACKGROUND
Mohanty S, Trivedi C, Horton P, Della Rocca DG, Gianni C, MacDonald B, Mayedo A, Sanchez J, Gallinghouse GJ, Al-Ahmad A, Horton RP, Burkhardt JD, Dello Russo A, Casella M, Tondo C, Themistoclakis S, Forleo G, Di Biase L, Natale A. Natural History of Arrhythmia After Successful Isolation of Pulmonary Veins, Left Atrial Posterior Wall, and Superior Vena Cava in Patients With Paroxysmal Atrial Fibrillation: A Multi-Center Experience. J Am Heart Assoc. 2021 Jun;10(11):e020563. doi: 10.1161/JAHA.120.020563. Epub 2021 May 17.
Reference Type
BACKGROUND
Kim TH, Park J, Park JK, Uhm JS, Joung B, Hwang C, Lee MH, Pak HN. Linear ablation in addition to circumferential pulmonary vein isolation (Dallas lesion set) does not improve clinical outcome in patients with paroxysmal atrial fibrillation: a prospective randomized study. Europace. 2015 Mar;17(3):388-95. doi: 10.1093/europace/euu245. Epub 2014 Oct 21.
Reference Type
BACKGROUND
Hindricks G, Piorkowski C, Tanner H, Kobza R, Gerds-Li JH, Carbucicchio C, Kottkamp H. Perception of atrial fibrillation before and after radiofrequency catheter ablation: relevance of asymptomatic arrhythmia recurrence. Circulation. 2005 Jul 19;112(3):307-13. doi: 10.1161/CIRCULATIONAHA.104.518837. Epub 2005 Jul 11.
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BACKGROUND
Jalife J, Kaur K. Atrial remodeling, fibrosis, and atrial fibrillation. Trends Cardiovasc Med. 2015 Aug;25(6):475-84. doi: 10.1016/j.tcm.2014.12.015. Epub 2014 Dec 31.
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BACKGROUND
Atienza F, Almendral J, Moreno J, Vaidyanathan R, Talkachou A, Kalifa J, Arenal A, Villacastin JP, Torrecilla EG, Sanchez A, Ploutz-Snyder R, Jalife J, Berenfeld O. Activation of inward rectifier potassium channels accelerates atrial fibrillation in humans: evidence for a reentrant mechanism. Circulation. 2006 Dec 5;114(23):2434-42. doi: 10.1161/CIRCULATIONAHA.106.633735. Epub 2006 Nov 13.
Reference Type
BACKGROUND
Aryana A, Allen SL, Pujara DK, Bowers MR, O'Neill PG, Yamauchi Y, Shigeta T, Vierra EC, Okishige K, Natale A. Concomitant Pulmonary Vein and Posterior Wall Isolation Using Cryoballoon With Adjunct Radiofrequency in Persistent Atrial Fibrillation. JACC Clin Electrophysiol. 2021 Feb;7(2):187-196. doi: 10.1016/j.jacep.2020.08.016. Epub 2020 Oct 28.
Reference Type
BACKGROUND
Aryana A, Thiemann AM, Pujara DK, Cossette LL, Allen SL, Bowers MR, Gandhavadi M, Heath R, Trivedi AD, O'Neill PG, Ellis ER, d'Avila A. Pulmonary Vein Isolation With and Without Posterior Wall Isolation in Paroxysmal Atrial Fibrillation: IMPPROVE-PAF Trial. JACC Clin Electrophysiol. 2023 May;9(5):628-637. doi: 10.1016/j.jacep.2023.01.014. Epub 2023 Mar 22.
Reference Type
DERIVED
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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IMPPROVE-PAF
Identifier Type: -
Identifier Source: org_study_id
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Comparison of Pulmonary Vein Ablation With or Without Left Atrial Posterior Wall Ablation for Persistent AF (PIVoTAL)
NCT03057548
COMPLETED
NA
Posterior Wall Substrate Modification Using Irreversible Electroporation for Paroxysmal Atrial Fibrillation
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TERMINATED
NA
Pulmonary Vein Isolation in Typical Atrial Flutter and Heart Failure
NCT06817447
NOT_YET_RECRUITING
NA
Cryoballoon Ablation in Patients With Longstanding Persistent Atrial Fibrillation
NCT02294929
UNKNOWN
NA
A Prospective Randomized Study Comparing Radiofrequency Energy With Cryoenergy
NCT00773539
UNKNOWN
PHASE4