NCT04190186

Hybrid Ablation Plus Medical Therapy for Persistent Atrial Fibrillation

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 55 (actual)
• Sponsor: University of Rochester · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Persistent Atrial Fibrillation

Interventions

Type	Name	Description
DEVICE	Insertable Cardiac Monitor	Implantable device that provides accurate daily transmission of cardiac electrical data for arrhythmia detection.

Timeline

• Start date: 2020-06-25
• Primary completion: 2024-02-15
• Completion: 2024-02-15
• First posted: 2019-12-09
• Last updated: 2025-07-29
• Results posted: 2025-07-29

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated device study