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

BIO-Precision Study

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.

Study Overview

• Status: Terminated
• Conditions: Atrial Fibrillation

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.

• Study Type: Observational
• Enrollment (Actual): 84

Contacts and Locations

Study Locations

• United States
  • Florida
    • Kissimmee, Florida, United States, 34741
      • Cardiovascular Associates, Inc.
    • Winter Park, Florida, United States, 32792
      • Florida Cardiology
  • Missouri
    • Saint Louis, Missouri, United States, 63136
      • St. Louis Heart and Vascular
  • Ohio
    • Columbus, Ohio, United States, 43210
      • The Ohio State University
    • Toledo, Ohio, United States, 43615
      • ProMedica Physicians Cardiology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The investigator is responsible for screening all potential subjects and selecting those who are appropriate for study inclusion. Potential subjects will be evaluated to determine if they meet the inclusion and exclusion criteria. The subjects selected for participation should be from the investigator's general patient population according to the inclusion and exclusion criteria. Patients who require a legally authorized representative will not be allowed in the study.

Description

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

After the pre-Holter observation period but prior to 48 hr Holter monitoring initiation, confirm the absence of the following exclusion criteria based on the remote interrogation collected at the end of the observation period:

• 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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diagnostic Sensitivity	The diagnostic sensitivity of the BIOMONITOR will be determined by comparing AF events detected by the BIOMONITOR and 48 hr Holter monitor for each subject. Diagnostic sensitivity is the ability of the BIOMONITOR to correctly identify subjects who have true AF as determined by the Holter monitor. It is calculated as the number of participants with a true BIOMONITOR AF detection divided by the sum of the number of participants with a true BIOMONITOR AF detection and the number of participants with a false negative BIOMONITOR AF detection.	48 hours

Collaborators and Investigators

• Sponsor: Biotronik, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): September 25, 2019
• Primary Completion (Actual): February 24, 2021
• Study Completion (Actual): February 24, 2021

Study Registration Dates

• First Submitted: August 30, 2019
• First Submitted That Met QC Criteria: August 30, 2019
• First Posted (Actual): September 4, 2019

Study Record Updates

• Last Update Posted (Actual): April 5, 2022
• Last Update Submitted That Met QC Criteria: February 7, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: BIO-Precision

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Individual participant data that underlie the results reported in publications, after deidentification, may be shared.
• IPD Sharing Time Frame: Beginning no later than 12 months and ending no earlier than 3 years following publication.
• IPD Sharing Access Criteria: Researchers who propose a methodologically sound proposal for analysis that is not pre-planned or already approved with another researcher and achieves aims in approved proposal, including but not limited sub-analysis or meta-analysis, will be considered. Proposals should be directed to BIOTRONIK Clinical Studies (BIOTRONIK Inc., Attn: Clinical Studies, 6024 Jean Road, Lake Oswego, OR; 1-800-547-0394). To gain access, data requestors will need to sign a data use/access agreement.
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No