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

NCT ID: NCT04076917

Last Updated: 2022-04-05

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 84 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-09-25
• Study Completion Date: 2021-02-24

Brief 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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• Meet the indications for subcutaneous cardiac rhythm monitor insertion according to local regulations
• Patient is able to understand the nature of the study and provide written informed consent
• Inserted within the prior 30 days, or scheduled for insertion within 14 days, with BIOTRONIK's most current subcutaneous cardiac rhythm monitor
• Diagnosed with paroxysmal atrial fibrillation and being evaluated for an AF ablation
• Agree to wearing a 48 hr Holter monitor
• Able and willing to complete all study visits at the study site for the study duration
• Able and willing to use a CardioMessenger® and accepts Home Monitoring concept
• Age greater than or equal to 18 years

Exclusion Criteria

• Patient meets none of the indications for a BIOMONITOR
• Patient is planned to have an ablation prior to BIOMONITOR insertion or 48 hr Holter monitoring visit
• Patient is currently diagnosed with long-standing persistent or permanent AF
• Patient is enrolled in another study that may change or alter the cardiac rhythm that occurs prior to the completion of the Holter
• Currently indicated for or implanted with a pacemaker, ICD device, or hemodynamic monitoring system
• Life expectancy less than 6 months
• Patients reporting pregnancy at the time of enrollment

For patients enrolled after BIOMONITOR insertion:

• R-wave sensing <0.25 mV according to the most recent remote or in-person device interrogation available prior to enrollment

• No AF episodes observed or transmitted during pre-Holter observation period
• R-wave sensing <0.25 mV during pre-Holter observation period as reported by the 24 hr mean or mean value since last follow-up

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Biotronik, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Cardiovascular Associates, Inc.

Kissimmee, Florida, United States

Florida Cardiology

Winter Park, Florida, United States

St. Louis Heart and Vascular

St Louis, Missouri, United States

The Ohio State University

Columbus, Ohio, United States

ProMedica Physicians Cardiology

Toledo, Ohio, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

BIO-Precision

Identifier Type: -

Identifier Source: org_study_id