Hybrid Ablation Plus Medical Therapy for Persistent Atrial Fibrillation

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

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).

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.

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