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

Stopped early

Conditions studied: Atrial Fibrillation

In brief

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.

Key facts

Study ID

NCT04076917

Run by

Biotronik, Inc.

People needed

84

Starts

2019-09-25

Expected to finish

2021-02-24

Last updated by the study team

2022-04-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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
• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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