Clinical trial NCT04076917: Assessment of the Utility of BIOMONITOR to Identify Atrial Fibrillation (AF) in Ablation Candidates Using Precise AF Detection
Official title: BIO-Precision Study
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Atrial Fibrillation
Lead sponsor: Biotronik, Inc.
Sponsor class: INDUSTRY
First posted: 2019-09-04
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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

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

Primary outcomes:
measure: Diagnostic Sensitivity
timeFrame: 48 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Kissimmee
country: United States
facility: Cardiovascular Associates, Inc.
state: Florida
city: Winter Park
country: United States
facility: Florida Cardiology
state: Florida
city: Saint Louis
country: United States
facility: St. Louis Heart and Vascular
state: Missouri
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
city: Toledo
country: United States
facility: ProMedica Physicians Cardiology
state: Ohio
Study officials:
References: