Atrial FibrillationBIO-PrecisionNCT04076917
Assessment of the Utility of BIOMONITOR to Identify Atrial Fibrillation (AF) in Ablation Candidates Using Precise AF Detection
An observational study of Atrial Fibrillation, run by Biotronik, Inc. at 5 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- How many people
- 84 participants
- Where
- 5 sitesUnited States
- Study dates
- 25 Sep 2019to 24 Feb 2021
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
The Ohio State University
Columbus, Ohio, 43210
Cardiovascular Associates, Inc.
Kissimmee, Florida, 34741
St. Louis Heart and Vascular
St Louis, Missouri, 63136
ProMedica Physicians Cardiology
Toledo, Ohio, 43615
Florida Cardiology
Winter Park, Florida, 32792
About this study
Official title: 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.
Read the 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.
- Conditions
- Atrial Fibrillation
- Medical subject headings
- Atrial Fibrillation
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2019
- Study start25 Sep 2019
- Primary completion24 Feb 2021
- Study completion24 Feb 2021
Why it stopped: This study was terminated by the sponsor since study timelines were extended significantly due to slow enrollment, partly influenced by the COVID-19 pandemic.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biotronik, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04076917
- Sponsor's protocol ID
- BIO-Precision
- Acronym
- BIO-Precision
- Status last verified
- Feb 2022
- First submitted
- 30 Aug 2019
- Last updated
- 5 Apr 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in publications, after deidentification, may be shared.
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BIO-Precision Study
- ClinicalTrials.gov ID
- NCT04076917
- Acronym / sponsor ID
- BIO-Precision / BIO-Precision
- Conditions
- Atrial Fibrillation
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: This study was terminated by the sponsor since study timelines were extended significantly due to slow enrollment, partly influenced by the COVID-19 pandemic.
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Biotronik, Inc.Industry (pharma, biotech, devices)
- Study start
- 25 Sep 2019 (actual)
- Primary completion
- 24 Feb 2021 (actual)
- Study completion
- 24 Feb 2021 (actual)
- First posted
- 4 Sep 2019 (actual)
- Results
- Posted 5 Apr 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Diagnostic Sensitivity
Time frame: 48 hours
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in publications, after deidentification, may be shared.
Related trials for Atrial Fibrillation
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Paroxysmal AF
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
Concomitant Procedures, Atrial Fibrillation
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CONVERGE Post-Approval Study (PAS)
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Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
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RecruitingPhase 2
Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
Atrial Fibrillation (AF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation, run by Biotronik, Inc. at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 5 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Apr 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic Sensitivity (time frame: 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2022.