Atrial Fibrillation Clinical Trial
— BIO-PrecisionOfficial title:
BIO-Precision Study
Verified date | February 2022 |
Source | Biotronik, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Terminated |
Enrollment | 84 |
Est. completion date | February 24, 2021 |
Est. primary completion date | February 24, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | The Ohio State University | Columbus | Ohio |
United States | Cardiovascular Associates, Inc. | Kissimmee | Florida |
United States | St. Louis Heart and Vascular | Saint Louis | Missouri |
United States | ProMedica Physicians Cardiology | Toledo | Ohio |
United States | Florida Cardiology | Winter Park | Florida |
Lead Sponsor | Collaborator |
---|---|
Biotronik, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 |
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