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

NCT04076917 | Terminated Results

• 1 other identifier: BIO-Precision
• Study Type: observational
• Target: 84
• Locations: 1 country
• Sites: 5

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.

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

• 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Biotronik, Inc.: lead

Study Sites (5)

Cardiovascular Associates, Inc.

Kissimmee, Florida, 34741, United States

Location

Florida Cardiology

Winter Park, Florida, 32792, United States

Location

St. Louis Heart and Vascular

St Louis, Missouri, 63136, United States

Location

The Ohio State University

Columbus, Ohio, 43210, United States

Location

ProMedica Physicians Cardiology

Toledo, Ohio, 43615, United States

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Senior Manager, Scientific Affairs
• Organization: BIOTRONIK, Inc.

crystal.miller@biotronik.com

800-547-0394

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 30, 2019
• First Posted: September 4, 2019
• Study Start: September 25, 2019
• Primary Completion: February 24, 2021
• Study Completion: February 24, 2021
• Last Updated: April 5, 2022
• Results First Posted: April 5, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning no later than 12 months and ending no earlier than 3 years following publication.
• 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.

Locations

US (5)