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Insufficient enrollment related to ILR coverage barriers and the resulting inability to meet timelines with the available funding.
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| Name | Class |
|---|---|
| Boston Scientific Corporation | INDUSTRY |
| Databean | INDUSTRY |
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The purpose of this study is to compare the efficacy and safety between pulmonary vein isolation (PVI) alone versus PVI with left atrial (LA) posterior wall isolation (PWI) using pulsed-field ablation (PFA) in the treatment of patients with paroxysmal atrial fibrillation (PAF).
This is an investigator-initiated, prospective, randomized, multi-center, Investigational Device Exemption (IDE) study. Subjects undergoing first-time ablation for paroxysmal atrial fibrillation will be randomized to receive either pulmonary vein isolation (PVI) alone or PVI combined with posterior wall isolation (PWI) using pulsed field ablation (PFA) with the FARAWAVE PFA catheter.
Following the index procedure, all participants will enter a 3-month blanking period, during which they will be closely monitored. After this period, anti-arrhythmic drug (AAD) therapy will be discontinued for all patients. Throughout the entire study, patients will be monitored using an implantable loop recorder (ILR) to assess the primary outcome of efficacy.
The study includes a 12-month follow-up period, and the primary objective is to assess and compare the efficacy, defined as an improvement in freedom from all-atrial arrhythmias, and safety, defined as the occurrence of all procedure-related complications.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pulmonary Vein Isolation (PVI) only | Active Comparator | Pulsed field ablation of the pulmonary veins only. |
|
| Pulmonary Vein Isolation and Posterior Wall Isolation ( PVI+PWI) | Active Comparator | Pulsed field ablation of the pulmonary veins and the posterior wall of the left atrium. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Farapulse PFA, Pulmonary Vein Isolation alone | Device | Ablation of the pulmonary veins for the treatment of Paroxysmal Atrial Fibrillation using pulsed field ablation. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Procedural success, defined as freedom from of all documented atrial arrhythmias episodes after the 3-month blanking period. | will be assessed by:
| 12 months |
| The primary safety endpoint is a composite of acute procedure-related complications and any other major adverse events within the 12 months following the ablation procedure. | All number of acute procedure-related complications will be reported and assessed including: atrio-esophageal fistula, cardiac perforation, pulmonary vein (PV) stenosis, acute kidney injury, phrenic nerve paralysis, thromboembolic events, stroke, or transient ischemic attacks (TIA), and other major adverse events within the 12 months following the ablation procedure: pericarditis cardiac tamponade pericardial effusion, coronary artery spasm, Vascular access complication/major bleeding, local hematoma, ecchymosis left atrium or vascular laceration | 12 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Freedom from atrial arrhythmias medication | Time and dose of anti arrhythmic medications use will be compared between the two groups. | 12 Months |
| Procedural time | procedural time will be compared among groups. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jorge E Romero, MD | Massachusetts General Hospital | Principal Investigator |
| William H Sauer, MD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Grandview Medical Center | Birmingham | Alabama | 35243 | United States | ||
| MedStar Washington Hospital Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24345399 | Background | Chugh SS, Havmoeller R, Narayanan K, Singh D, Rienstra M, Benjamin EJ, Gillum RF, Kim YH, McAnulty JH Jr, Zheng ZJ, Forouzanfar MH, Naghavi M, Mensah GA, Ezzati M, Murray CJ. Worldwide epidemiology of atrial fibrillation: a Global Burden of Disease 2010 Study. Circulation. 2014 Feb 25;129(8):837-47. doi: 10.1161/CIRCULATIONAHA.113.005119. Epub 2013 Dec 17. | |
| 27411521 |
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| Farapulse PFA, Pulmonary Vein Isolation and Left atrial Posterior Wall Isolation | Device | Ablation of the pulmonary veins and the left atrium posterior wall for the treatment of Paroxysmal Atrial Fibrillation using pulsed field ablation. |
|
| 12 Months |
| Procedure-related Recurrencies | Rate of PV and PW reconnection in patients undergoing repeat ablation procedures for recurrence of AF. | 12 Months |
| Atrial Fibrillation Effect on Quality-of-life Questionnaire (AFEQT). | It reports scores from 0 to 100. A score of 0 corresponds to complete disability, while a score of 100 describes the highest level of QoL | 12 Months |
| Use of amiodarone | Number of patients using amiodarone, and duration of using it will be compared among groups. | 12 months |
| Complications. | Incidence of acute procedure-related complications and long-term procedure-related complication. | 12 Months. |
| fluoroscopy time. | fluoroscopy time will be asses between the two groups. | during 1-2 hours procedure. |
| Pulsed field ablation (PFA) applications during procedure. | The PFA count will be compared by the two groups. | During 1-2 hours procedure. |
| first-pass pulmonary vein isolation (PVI). | the rates of first pass PVI will be compared between the two groups. | During 1-2 hours procedure. |
| Washington D.C. |
| District of Columbia |
| 20010 |
| United States |
| St. Vincent's Health System, Inc. d/b/a Ascension St. Vincent's | Jacksonville | Florida | 32204 | United States |
| HCA Florida Mercy Hospital | Miami | Florida | 33133 | United States |
| St. Luke's Boise Medical Center | Boise | Idaho | 83712 | United States |
| Maine Medical Center | Portland | Maine | 04102 | United States |
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | United States |
| Lahey Hospital and Medical Center | Burlington | Massachusetts | 01805 | United States |
| Corewell Health William Beaumont Hospital | Royal Oak | Michigan | 48073 | United States |
| The Valley Hospital | Paramus | New Jersey | 07652 | United States |
| North Shore University Hospital, Northwell Health | Manhasset | New York | 11030 | United States |
| Doylestown Hospital | Doylestown | Pennsylvania | 18901 | United States |
| Trident Medical Center | Charleston | South Carolina | 29406 | United States |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| Orion Medical | Houston | Texas | 77034 | United States |
| Methodist Hospital-San Antonio | San Antonio | Texas | 78229 | United States |
| University of Texas Health Science Center at San Antonio | San Antonio | Texas | 78229 | United States |
| University of Washington Medical Center | Seattle | Washington | 98195 | United States |
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| 35647644 | Background | Ekanem E, Reddy VY, Schmidt B, Reichlin T, Neven K, Metzner A, Hansen J, Blaauw Y, Maury P, Arentz T, Sommer P, Anic A, Anselme F, Boveda S, Deneke T, Willems S, van der Voort P, Tilz R, Funasako M, Scherr D, Wakili R, Steven D, Kautzner J, Vijgen J, Jais P, Petru J, Chun J, Roten L, Futing A, Rillig A, Mulder BA, Johannessen A, Rollin A, Lehrmann H, Sohns C, Jurisic Z, Savoure A, Combes S, Nentwich K, Gunawardene M, Ouss A, Kirstein B, Manninger M, Bohnen JE, Sultan A, Peichl P, Koopman P, Derval N, Turagam MK, Neuzil P; MANIFEST-PF Cooperative. Multi-national survey on the methods, efficacy, and safety on the post-approval clinical use of pulsed field ablation (MANIFEST-PF). Europace. 2022 Sep 1;24(8):1256-1266. doi: 10.1093/europace/euac050. |
| 38310489 | Background | Mohanty S, Casella M, Compagnucci P, Torlapati PG, Della Rocca DG, La Fazia VM, Gianni C, Chierchia GB, MacDonald B, Mayedo A, Khan UN, Allison J, Bassiouny M, Gallinghouse GJ, Burkhardt JD, Horton R, Al-Ahmad A, Di Biase L, de Asmundis C, Russo AD, Natale A. Acute Kidney Injury Resulting From Hemoglobinuria After Pulsed-Field Ablation in Atrial Fibrillation: Is it Preventable? JACC Clin Electrophysiol. 2024 Apr;10(4):709-715. doi: 10.1016/j.jacep.2023.12.008. Epub 2024 Feb 1. |
| 38175788 | Background | Venier S, Vaxelaire N, Jacon P, Carabelli A, Desbiolles A, Garban F, Defaye P. Severe acute kidney injury related to haemolysis after pulsed field ablation for atrial fibrillation. Europace. 2023 Dec 28;26(1):euad371. doi: 10.1093/europace/euad371. |
| 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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