Clinical trial NCT04190186: Hybrid Ablation Plus Medical Therapy for Persistent Atrial Fibrillation
Official title: Hybrid Ablation Plus Medical Therapy for Persistent Atrial Fibrillation (HYBRID AF)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Persistent Atrial Fibrillation
Keywords: Biotronik BioMonitor
ICM
AF Ablation
Atrial arrhythmia
Lead sponsor: University of Rochester
Sponsor class: OTHER
Collaborators: name: Biotronik, Inc.
First posted: 2019-12-09
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This clinical trial is designed to compare two management strategies for the treatment of asymptomatic/subclinical atrial fibrillation after ablation based on data from the Biotronik ICM (BioMonitor3® or future generation of Biotronik ICM).

Detailed description: In this study, subjects will be randomized (1:1) to conventional AF management vs. Biotronik ICM-guided AF management following ablation for persistent AF. Subjects will be followed for 15 months including a 3 month blanking period following AF ablation. The study subject population will include subjects with persistent atrial fibrillation (sustained AF episode lasting more than 7 days, but less than 1 year), according to current guideline indications for persistent AF ablation and ICM (Biotronik ICM) implantation.

Eligibility criteria: Inclusion Criteria:

* 18 years of age or older
* 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:

* Paroxysmal atrial fibrillation
* 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

Primary outcomes:
measure: Atrial fibrillation (AF) burden defined as the mean amount of time spent in AF over a pre-specified period of time (excluding short AF episodes of ≤30 seconds) by the Biotronik ICM (BioMonitor3® or future generation of Biotronik ICM).
timeFrame: Between months 3 and 15 after the ablation procedure (to exclude the first 3 month blanking period)
Secondary outcomes:
measure: Number of clinically significant (>30 min) atrial arrhythmia (atrial fibrillation, atrial flutter or atrial tachycardia) as detected and documented by Biotronik ICM after the performance of the index AF ablation procedure.
timeFrame: Between enrollment and 15 months (excluding the initial 3-month blanking period) (assessed in a recurrent event analysis).
measure: Number of symptomatic AF recurrence (regardless of duration).
timeFrame: Between enrollment and 15 months.
measure: Number of repeat AF ablation.
timeFrame: Between enrollment and 15 months.
measure: Number of cardiac hospitalization.
timeFrame: Between enrollment and 15 months.
measure: Number of Deaths.
timeFrame: Between enrollment and 15 months.
measure: Healthcare utilization, defined as hospitalization for any cause, ED visits, and unplanned office visits.
timeFrame: Between enrollment and 15 months.
measure: Atrial Flutter or Tachycardia.
timeFrame: Between months 3 and 15 after the ablation procedure (to exclude the first 3 month blanking period)
measure: Incidence of repeat procedures.
timeFrame: Between months 3 and 15 after the ablation procedure (to exclude the first 3 month blanking period)
measure: Major adverse events requiring rehospitalization during follow-up.
timeFrame: Between months 3 and 15 after the ablation procedure (to exclude the first 3 month blanking period)
measure: Quality of life (QOL) as assessed by Atrial Fibrillation Effect on QualiTy-of-life (AFEQT) questionnaire.
timeFrame: Between months 3 and 15 after the ablation procedure (to exclude the first 3 month blanking period)
Other outcomes:
Locations:
city: Ypsilanti
country: United States
facility: Michigan Heart, PC
state: Michigan
city: Tupelo
country: United States
facility: Cardiology Associates Research, LLC
state: Mississippi
city: Rochester
country: United States
facility: Rochester Regional Health
state: New York
city: Rochester
country: United States
facility: University of Rochester
state: New York
Study officials:
affiliation: University of Rochester
name: David Huang, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.