Hybrid Ablation Plus Medical Therapy for Persistent Atrial Fibrillation

Study Overview
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Brief Summary
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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
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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.

Official Title
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Hybrid Ablation Plus Medical Therapy for Persistent Atrial Fibrillation (HYBRID AF)

Conditions
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Persistent Atrial Fibrillation

Intervention / Treatment
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* Device: Insertable Cardiac Monitor


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Biotronik ICM-guided AF management<br>ICM obtained data will be actively used to guide and monitor treatment . | Device: Insertable Cardiac Monitor<br>* Implantable device that provides accurate daily transmission of cardiac electrical data for arrhythmia detection.<br>* Other names: BioMonitor3® or future generation of Biotronik ICM;|
| No Intervention: Conventional AF Management<br>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). | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 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. | Between months 3 and 15 after the ablation procedure (to exclude the first 3 month blanking period) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 symptomatic AF recurrence (regardless of duration). |  | Between enrollment and 15 months. | 
| Number of repeat AF ablation. |  | Between enrollment and 15 months. | 
| Number of cardiac hospitalization. |  | Between enrollment and 15 months. | 
| Number of Deaths. |  | Between enrollment and 15 months. | 
| Healthcare utilization, defined as hospitalization for any cause, ED visits, and unplanned office visits. |  | Between enrollment and 15 months. | 
| Atrial Flutter or Tachycardia. | Incidence of atrial flutter or tachycardia after the index ablation procedure | Between months 3 and 15 after the ablation procedure (to exclude the first 3 month blanking period) | 
| 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) | 
| 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Biotronik BioMonitor, ICM, AF Ablation, Atrial arrhythmia