NCT04076917

Assessment of the Utility of BIOMONITOR to Identify Atrial Fibrillation (AF) in Ablation Candidates Using Precise AF Detection

BIO-Precision Study

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 84 (actual)
• Sponsor: Biotronik, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the diagnostic utility of BIOTRONIK's subcutaneous cardiac rhythm monitor for the detection of AF prior to an ablation procedure.

Detailed description

BIO-Precision is a post-market study investigating the utility of atrial fibrillation (AF) detection using BIOTRONIK's subcutaneous cardiac rhythm monitor, BIOMONITOR. The purpose of this study is to evaluate the diagnostic utility of BIOTRONIK's BIOMONITOR for the detection and confirmation of AF prior to an ablation procedure. Study population includes patients with paroxysmal AF being evaluated for an AF ablation. Holter monitoring for 48 hours will be performed after insertion of the BIOMONITOR but prior to AF ablation. This study will enroll up to 100 subjects, to obtain 60 usable Holter recordings, at 5 study sites within the United States (U.S.). Study subjects will be followed for three months after the completion of a 48 hr Holter monitor.

Conditions

• Atrial Fibrillation

Timeline

• Start date: 2019-09-25
• Primary completion: 2021-02-24
• Completion: 2021-02-24
• First posted: 2019-09-04
• Last updated: 2022-04-05
• Results posted: 2022-04-05

Locations

5 sites across 1 country: United States