Hybrid Ablation Plus Medical Therapy for Persistent Atrial Fibrillation
NCT ID: NCT04190186
Last Updated: 2025-07-29
Study Results
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View full resultsBasic Information
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COMPLETED
NA
55 participants
INTERVENTIONAL
2020-06-25
2024-02-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Biotronik ICM-guided AF management
ICM obtained data will be actively used to guide and monitor treatment .
Insertable Cardiac Monitor
Implantable device that provides accurate daily transmission of cardiac electrical data for arrhythmia detection.
Conventional AF Management
Treating physicians/nurses will be blinded to the AF episodes data from the monitor, but will be provided information on asystole, or ventricular arrhythmia events (for safety).
No interventions assigned to this group
Interventions
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Insertable Cardiac Monitor
Implantable device that provides accurate daily transmission of cardiac electrical data for arrhythmia detection.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* History of persistent atrial fibrillation (sustained AF episode lasting more than 7 days, but less than a year)
* Planned to undergo first AF ablation with successful Biotronik ICM implant before or at time of ablation
Exclusion Criteria
* Long persistent atrial fibrillation (continuous atrial fibrillation that lasts more than 1 year)
* Permanent atrial fibrillation
* Left atrial diameter of 60 mm or greater
* Patients with CHF status prohibiting EP study and ablation, but may be re-considered for enrollment later after effective treatment
* Patients with metabolic derangements (e.g. renal/hepatic failure, electrolyte disturbance, etc.), prohibiting EP study and ablation or antiarrhythmic medical therapy (e.g. dofetilide, sotalol or amiodarone, etc.)
* Patients with an intra-cardiac thrombus, but may be re-considered for enrollment later after effective treatment
* Serious known concomitant disease with a life expectancy of \< 1 year
* Pregnancy or nursing
* Unwilling or unable to give informed consent
* Existing CIED such as pacemaker or ICD
18 Years
ALL
No
Sponsors
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Biotronik, Inc.
INDUSTRY
University of Rochester
OTHER
Responsible Party
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David Huang
Professor Medicine M&D-Cardiology Div
Principal Investigators
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David Huang, MD
Role: PRINCIPAL_INVESTIGATOR
University of Rochester
Locations
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Michigan Heart, PC
Ypsilanti, Michigan, United States
Cardiology Associates Research, LLC
Tupelo, Mississippi, United States
Rochester Regional Health
Rochester, New York, United States
University of Rochester
Rochester, New York, United States
Countries
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References
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Verma A, Jiang CY, Betts TR, Chen J, Deisenhofer I, Mantovan R, Macle L, Morillo CA, Haverkamp W, Weerasooriya R, Albenque JP, Nardi S, Menardi E, Novak P, Sanders P; STAR AF II Investigators. Approaches to catheter ablation for persistent atrial fibrillation. N Engl J Med. 2015 May 7;372(19):1812-22. doi: 10.1056/NEJMoa1408288.
Huang DT, Monahan KM, Zimetbaum P, Papageorgiou P, Epstein LM, Josephson ME. Hybrid pharmacologic and ablative therapy: a novel and effective approach for the management of atrial fibrillation. J Cardiovasc Electrophysiol. 1998 May;9(5):462-9. doi: 10.1111/j.1540-8167.1998.tb01837.x.
Kirchhof P, Calkins H. Catheter ablation in patients with persistent atrial fibrillation. Eur Heart J. 2017 Jan 1;38(1):20-26. doi: 10.1093/eurheartj/ehw260. Epub 2016 Jul 7.
Willems S, Khairy P, Andrade JG, Hoffmann BA, Levesque S, Verma A, Weerasooriya R, Novak P, Arentz T, Deisenhofer I, Rostock T, Steven D, Rivard L, Guerra PG, Dyrda K, Mondesert B, Dubuc M, Thibault B, Talajic M, Roy D, Nattel S, Macle L; ADVICE Trial Investigators*. Redefining the Blanking Period After Catheter Ablation for Paroxysmal Atrial Fibrillation: Insights From the ADVICE (Adenosine Following Pulmonary Vein Isolation to Target Dormant Conduction Elimination) Trial. Circ Arrhythm Electrophysiol. 2016 Aug;9(8):e003909. doi: 10.1161/CIRCEP.115.003909.
Schreiber D, Rostock T, Frohlich M, Sultan A, Servatius H, Hoffmann BA, Luker J, Berner I, Schaffer B, Wegscheider K, Lezius S, Willems S, Steven D. Five-year follow-up after catheter ablation of persistent atrial fibrillation using the stepwise approach and prognostic factors for success. Circ Arrhythm Electrophysiol. 2015 Apr;8(2):308-17. doi: 10.1161/CIRCEP.114.001672. Epub 2015 Mar 5.
Reiffel JA, Camm AJ, Belardinelli L, Zeng D, Karwatowska-Prokopczuk E, Olmsted A, Zareba W, Rosero S, Kowey P; HARMONY Investigators. The HARMONY Trial: Combined Ranolazine and Dronedarone in the Management of Paroxysmal Atrial Fibrillation: Mechanistic and Therapeutic Synergism. Circ Arrhythm Electrophysiol. 2015 Oct;8(5):1048-56. doi: 10.1161/CIRCEP.115.002856. Epub 2015 Jul 30.
Tondo C, Iacopino S, Pieragnoli P, Molon G, Verlato R, Curnis A, Landolina M, Allocca G, Arena G, Fassini G, Sciarra L, Luzi M, Manfrin M, Padeletti L; ClinicalService 1STOP Project Investigators. Pulmonary vein isolation cryoablation for patients with persistent and long-standing persistent atrial fibrillation: Clinical outcomes from the real-world multicenter observational project. Heart Rhythm. 2018 Mar;15(3):363-368. doi: 10.1016/j.hrthm.2017.10.038. Epub 2017 Oct 26.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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00004318
Identifier Type: -
Identifier Source: org_study_id
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