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The purpose of this study it to learn whether pulmonary vein isolation (PVI) along with ablation of the posterior left atrial wall (PLAW) will reduce the likelihood of atrial fibrillation (AF) recurrence in patients with persistent or long-standing persistent AF one year after an ablation procedure in comparison to a PVI ablation procedure, alone.
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.
Patients with persistent or long-standing persistent atrial fibrillation will be enrolled in this multi-center, randomized, prospective, single-blinded study. All patients are required to be in atrial fibrillation (AF) on the day of the ablation procedure. After ablation (isolation) of the pulmonary veins (PVI) is complete, and while still in the electrophysiology lab, all patients are randomized to either PVI, alone [Group 1] or the combination of PVI plus ablation of the posterior left atrial wall (PLAW) [Group 2]. For those patients randomized to PVI, their ablation procedure is complete at this time. For those patients randomized to PVI plus PLAW, they will have the additional ablation to the posterior left atrial wall performed.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pulmonary Vein Isolation (PVI) | Active Comparator | Cryoablation only of Pulmonary Veins or Radiofrequency ablation only of Pulmonary Veins Pulmonary Vein Isolation (PVI) alone. |
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| PVI & Posterior Left Atrial Ablation | Experimental | 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cryo or Radiofrequency (RF) Ablation only of Pulmonary Veins | Procedure | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 1-year Freedom From Recurrent Atrial Arrhythmias | The results of 7-14 day ambulatory ECG monitoring and ECGs performed at 3, 6 and 12 months will be used to document freedom from recurrent atrial fibrillation at one year post-ablation. | One year |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Complication Rate | The type and frequency of complications following catheter ablation | During follow-up, assessed for an estimated total of one year. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Arash Aryana, MD | Mercy General Hospital and Dignity Health Heart and Vascular Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mercy General Hospital and Dignity Health Heart and Vascular Institute | Sacramento | California | 95819 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 9725923 | Background | 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. | |
| 20206320 | Background |
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| ID | Title | Description |
|---|---|---|
| FG000 | Pulmonary Vein Isolation (PVI) | Cryoablation only of Pulmonary Veins or Radiofrequency (RF) ablation only of Pulmonary Veins Pulmonary Vein Isolation (PVI) alone. Cryo or 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 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 12, 2016 | Jun 7, 2025 |
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| Cryo or RF Ablation of Pulmonary Veins plus Ablation of the PLAW | Procedure | 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) |
|
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| Heart Center, Japan Red Cross Yokohama-city Bay Hospital |
| Yokohama |
| Japan |
| 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. |
| 19804549 | Background | 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. |
| 26515166 | Background | 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. |
| 30885736 | 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. |
| 21954878 | Background | 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. |
| 29700055 | Background | 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. |
| 29250289 | Background | 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. |
| 25644659 | Background | 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. |
| 30060879 | Background | 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. |
| 30767365 | Background | 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. |
| 28625929 | 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. |
| 12578877 | Background | 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. |
| FG001 | 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) |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Pulmonary Vein Isolation (PVI) | Cryoablation only of Pulmonary Veins or Radiofrequency ablation only of Pulmonary Veins Pulmonary Vein Isolation (PVI) alone. Cryo or 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 |
| BG001 | 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) |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Long-standing persistent atrial fibrillation | Count of Participants | Participants |
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| Persistent atrial fibrillation | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 1-year Freedom From Recurrent Atrial Arrhythmias | The results of 7-14 day ambulatory ECG monitoring and ECGs performed at 3, 6 and 12 months will be used to document freedom from recurrent atrial fibrillation at one year post-ablation. | Study cohort consisted of patients undergoing first-time cryoballoon ablation for symptomatic persistent/long-standing persistent atrial ablation (55 subjects in the PVI isolation arm and 55 subjects in the PVI+PWI arm) were analyzed for freedom from recurrence of atrial fibrillation and all atrial arrhythmias at one-year post-study ablation. | Posted | Count of Participants | Participants | One year |
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| Secondary | Overall Complication Rate | The type and frequency of complications following catheter ablation | Posted | Count of Participants | Participants | During follow-up, assessed for an estimated total of one year. |
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1 year following the study ablation procedure.
All study subjects were queried regarding any adverse or serious adverse events at each study visit (3, 6 and 12 months post-study ablation procedure). Additionally, the investigator and research coordinator reviewed each subject's electronic medical record at the time of all study visits to assess for any adverse events not reported by the subjects.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | PVI Only | The incidence of adverse events was 5.5% in PVI only group. | 0 | 55 | 3 | 55 | 0 | 55 |
| EG001 | PVI+PWI | The incidence of adverse events was 5.5% in PVI+PWI group. | 0 | 55 | 3 | 55 | 0 | 55 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac Failure | Cardiac disorders | MedRA (12.0) | Systematic Assessment | Congestive Heart Failure Exacerbation |
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| Pericarditis | Cardiac disorders | MedDRA (12.0) | Systematic Assessment |
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| Pericardial Effusion | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
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| Persistent Phrenic Nerve Palsy | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
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| Bradycardia | Cardiac disorders | MedDRA 12.0 | Systematic Assessment | Symptomatic bradycardia requiring implantation of a permanent pacemaker |
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| Groin Vascular Complication | Vascular disorders | MedDRA 12.0 | Systematic Assessment |
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Slight variations in ablation strategy/periprocedural management may have existed among operators. Baseline Left Atrial Posterior Wall low-voltage data were collected in AF at procedure start, which could have implications. Subclinical manifestations of complications (ex. esophageal ulcerations or asymptomatic PV stenosis) could not be excluded as diagnostic studies weren't performed in follow-up. Recurrent asymptomatic atrial arrhythmias could have occurred without detection during follow-up.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Arash Aryana, MD, PhD | SacEP Research | 916-453-2684 | a_aryana@outlook.com |
| Prot_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 5, 2019 | Jun 10, 2025 | ICF_001.pdf |
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Between 18 and 65 years |
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| >=65 years |
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| Japan |
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| Participants |
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