Comparison of Pulmonary Vein Ablation With or Without Left Atrial Posterior Wall Ablation for Persistent AF (PIVoTAL)
NCT ID: NCT03057548
Last Updated: 2025-11-05
Study Results
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View full resultsBasic Information
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COMPLETED
NA
110 participants
INTERVENTIONAL
2017-02-24
2020-05-31
Brief Summary
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The investigator hypothesizes that the combination of PVI plus PLAW isolation will result in a reduction in recurrence of atrial arrhythmias at one year after ablation.
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Detailed Description
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All study patients have the same follow-up after their ablation procedure: clinic visits at 3, 6, and 13 months; a heart event monitor is worn for 7-14 days before these visits. An echocardiogram is done at 4-6 months after the ablation procedure. Blood thinners are usually recommended for three months after the ablation procedure and then the need for continued use of blood thinners will be based on individual patient's medical history, stroke risk and the judgement of their study doctor. Information about patient's medical history, heart arrhythmias, and atrial fibrillation will be collected during the study. This information will be analyzed as part of the study.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Pulmonary Vein Isolation (PVI)
Cryoablation only of Pulmonary Veins
or
Radiofrequency ablation only of Pulmonary Veins
Pulmonary Vein Isolation (PVI) alone.
Cryo or Radiofrequency (RF) Ablation only of Pulmonary Veins
Artic Front Advance Cardiac Cryoablation System used to ablate the Pulmonary Veins
OR
FDA Approved RF Ablation Catheter used to ablate the Pulmonary Veins.
Ablation of the Pulmonary Veins alone
PVI & Posterior Left Atrial Ablation
Cryoablation of Pulmonary Veins plus RF ablation of Posterior Left Atrial Wall
or
Radiofrequency ablation of Pulmonary Veins plus RF ablation of Posterior Left Atrial Wall
PVI ablation plus ablation of the Posterior Left Atrial Wall (PLAW)
Cryo or RF Ablation of Pulmonary Veins plus Ablation of the PLAW
Cryoablation of the Pulmonary Veins plus RF Ablation of the PLAW
OR
RF Ablation of the Pulmonary Veins plus RF Ablation of the PLAW
Ablation of the Pulmonary Veins plus RF ablation of the Posterior Left Atrial Wall (PLAW)
Interventions
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Cryo or RF Ablation of Pulmonary Veins plus Ablation of the PLAW
Cryoablation of the Pulmonary Veins plus RF Ablation of the PLAW
OR
RF Ablation of the Pulmonary Veins plus RF Ablation of the PLAW
Ablation of the Pulmonary Veins plus RF ablation of the Posterior Left Atrial Wall (PLAW)
Cryo or Radiofrequency (RF) Ablation only of Pulmonary Veins
Artic Front Advance Cardiac Cryoablation System used to ablate the Pulmonary Veins
OR
FDA Approved RF Ablation Catheter used to ablate the Pulmonary Veins.
Ablation of the Pulmonary Veins alone
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* All patients must understand the requirements of the study and be willing to comply with the post-study follow-up requirements
* Patients must be in AF on the day of the procedure
Exclusion Criteria
* Patients with cerebral ischemic events (stroke or transient ischemic attack), myocardial infarction or unstable angina in the previous 2 months
* Patients with any corrected or uncorrected congenital heart disease
* Patients with a history of hypertrophic cardiomyopathy
* Patients with cardiomyopathy and a left ventricular ejection fraction \<35%
* Congestive heart failure, class IV
* Women who are known to be pregnant or have had a positive β-Human Chorionic Gonadotropin (β-HCG) test 7 days prior to procedure
* Patients whose life expectancy is \<1 year
* History of left-sided left atrial ablation (catheter or surgically-based)
* Mental impairment precluding the patient from providing informed consent or completing appropriate follow-up
18 Years
ALL
No
Sponsors
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Arash Aryana, MD
OTHER
Responsible Party
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Arash Aryana, MD
Cardiac Electrophysiologist / Principal Investigator
Principal Investigators
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Arash Aryana, MD
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
Heart Center, Japan Red Cross Yokohama-city Bay Hospital
Yokohama, , Japan
Countries
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References
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Brooks AG, Stiles MK, Laborderie J, Lau DH, Kuklik P, Shipp NJ, Hsu LF, Sanders P. Outcomes of long-standing persistent atrial fibrillation ablation: a systematic review. Heart Rhythm. 2010 Jun;7(6):835-46. doi: 10.1016/j.hrthm.2010.01.017. Epub 2010 Jan 22.
Haissaguerre M, Jais P, Shah DC, Takahashi A, Hocini M, Quiniou G, Garrigue S, Le Mouroux A, Le Metayer P, Clementy J. Spontaneous initiation of atrial fibrillation by ectopic beats originating in the pulmonary veins. N Engl J Med. 1998 Sep 3;339(10):659-66. doi: 10.1056/NEJM199809033391003.
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.
Segerson NM, Daccarett M, Badger TJ, Shabaan A, Akoum N, Fish EN, Rao S, Burgon NS, Adjei-Poku Y, Kholmovski E, Vijayakumar S, DiBella EV, MacLeod RS, Marrouche NF. Magnetic resonance imaging-confirmed ablative debulking of the left atrial posterior wall and septum for treatment of persistent atrial fibrillation: rationale and initial experience. J Cardiovasc Electrophysiol. 2010 Feb;21(2):126-32. doi: 10.1111/j.1540-8167.2009.01611.x. Epub 2009 Oct 5.
Cutler MJ, Johnson J, Abozguia K, Rowan S, Lewis W, Costantini O, Natale A, Ziv O. Impact of Voltage Mapping to Guide Whether to Perform Ablation of the Posterior Wall in Patients With Persistent Atrial Fibrillation. J Cardiovasc Electrophysiol. 2016 Jan;27(1):13-21. doi: 10.1111/jce.12830. Epub 2015 Oct 30.
Corradi D, Callegari S, Maestri R, Ferrara D, Mangieri D, Alinovi R, Mozzoni P, Pinelli S, Goldoni M, Privitera YA, Bartoli V, Astorri E, Macchi E, Vaglio A, Benussi S, Alfieri O. Differential structural remodeling of the left-atrial posterior wall in patients affected by mitral regurgitation with or without persistent atrial fibrillation: a morphological and molecular study. J Cardiovasc Electrophysiol. 2012 Mar;23(3):271-9. doi: 10.1111/j.1540-8167.2011.02187.x. Epub 2011 Sep 28.
Nagashima K, Okumura Y, Watanabe I, Nakahara S, Hori Y, Iso K, Watanabe R, Arai M, Wakamatsu Y, Kurokawa S, Mano H, Nakai T, Ohkubo K, Hirayama A. Hot Balloon Versus Cryoballoon Ablation for Atrial Fibrillation: Lesion Characteristics and Middle-Term Outcomes. Circ Arrhythm Electrophysiol. 2018 May;11(5):e005861. doi: 10.1161/CIRCEP.117.005861.
Okumura Y, Watanabe I, Iso K, Takahashi K, Nagashima K, Sonoda K, Mano H, Yamaguchi N, Kogawa R, Watanabe R, Arai M, Ohkubo K, Kurokawa S, Nakai T, Hirayama A. Mechanistic Insights Into Durable Pulmonary Vein Isolation Achieved by Second-Generation Cryoballoon Ablation. J Atr Fibrillation. 2017 Apr 30;9(6):1538. doi: 10.4022/jafib.1538. eCollection 2017 Apr-May.
Reddy VY, Sediva L, Petru J, Skoda J, Chovanec M, Chitovova Z, Di Stefano P, Rubin E, Dukkipati S, Neuzil P. Durability of Pulmonary Vein Isolation with Cryoballoon Ablation: Results from the Sustained PV Isolation with Arctic Front Advance (SUPIR) Study. J Cardiovasc Electrophysiol. 2015 May;26(5):493-500. doi: 10.1111/jce.12626. Epub 2015 Apr 15.
Aryana A, Baker JH, Espinosa Ginic MA, Pujara DK, Bowers MR, O'Neill PG, Ellenbogen KA, Di Biase L, d'Avila A, Natale A. Posterior wall isolation using the cryoballoon in conjunction with pulmonary vein ablation is superior to pulmonary vein isolation alone in patients with persistent atrial fibrillation: A multicenter experience. Heart Rhythm. 2018 Aug;15(8):1121-1129. doi: 10.1016/j.hrthm.2018.05.014.
Nishimura T, Yamauchi Y, Aoyagi H, Tsuchiya Y, Shigeta T, Nakamura R, Yamashita M, Asano M, Nakamura T, Suzuki H, Shimura T, Kurabayashi M, Keida T, Sasano T, Hirao K, Okishige K. The clinical impact of the left atrial posterior wall lesion formation by the cryoballoon application for persistent atrial fibrillation: Feasibility and clinical implications. J Cardiovasc Electrophysiol. 2019 Jun;30(6):805-814. doi: 10.1111/jce.13879. Epub 2019 Feb 23.
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.
Markides V, Schilling RJ, Ho SY, Chow AW, Davies DW, Peters NS. Characterization of left atrial activation in the intact human heart. Circulation. 2003 Feb 11;107(5):733-9. doi: 10.1161/01.cir.0000048140.31785.02.
Provided Documents
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Document Type: Study Protocol
Document Type: Informed Consent Form
Other Identifiers
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PIVotal-01
Identifier Type: -
Identifier Source: org_study_id
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