Hybrid Ablation Plus Medical Therapy for Persistent Atrial Fibrillation

Not Applicable

Completed

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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Biotronik ICM-guided AF management	Insertable Cardiac Monitor	ICM obtained data will be actively used to guide and monitor treatment .

Primary Outcome Measures

Name	Time	Method
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).	Between months 3 and 15 after the ablation procedure (to exclude the first 3 month blanking period)	In the present study AF burden will be assessed at 3-month intervals during the 12 months following the blanking period (3-months post-ablation), and the difference at the end of the follow-up period of one year will serve as the primary comparison outcome between the two treatment groups.

Secondary Outcome Measures

Name	Time	Method
Atrial Flutter or Tachycardia.	Between months 3 and 15 after the ablation procedure (to exclude the first 3 month blanking period)	Incidence of atrial flutter or tachycardia after the index ablation procedure
Incidence of repeat procedures.	Between months 3 and 15 after the ablation procedure (to exclude the first 3 month blanking period)
Major adverse events requiring rehospitalization during follow-up.	Between months 3 and 15 after the ablation procedure (to exclude the first 3 month blanking period)
Number of symptomatic AF recurrence (regardless of duration).	Between enrollment and 15 months.
Number of cardiac hospitalization.	Between enrollment and 15 months.
Healthcare utilization, defined as hospitalization for any cause, ED visits, and unplanned office visits.	Between enrollment and 15 months.
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.	Between enrollment and 15 months (excluding the initial 3-month blanking period) (assessed in a recurrent event analysis).
Number of repeat AF ablation.	Between enrollment and 15 months.
Quality of life (QOL) as assessed by Atrial Fibrillation Effect on QualiTy-of-life (AFEQT) questionnaire.	Between months 3 and 15 after the ablation procedure (to exclude the first 3 month blanking period)
Number of Deaths.	Between enrollment and 15 months.

Locations (4): 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