Hybrid Ablation Plus Medical Therapy for Persistent Atrial Fibrillation

University of Rochester

Status: Completed

Conditions: Persistent Atrial Fibrillation

Treatments: Device: Insertable Cardiac Monitor

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04190186

00004318

Details and patient eligibility

About

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).

Full 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.

Enrollment: 55 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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55 participants in 2 patient groups

Biotronik ICM-guided AF management

Active Comparator group

Description:

ICM obtained data will be actively used to guide and monitor treatment .

Treatment:

Device: Insertable Cardiac Monitor

Conventional AF Management

No Intervention group

Description:

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).