Hybrid Ablation Plus Medical Therapy for Persistent Atrial Fibrillation

Completed · Not applicable

Conditions studied: Persistent Atrial Fibrillation

In brief

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).

Key facts

Study ID

NCT04190186

Run by

University of Rochester

People needed

55

Starts

2020-06-25

Expected to finish

2024-02-15

Last updated by the study team

2025-07-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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