Atrial Fibrillation
Conditions
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.
Interventions
None listed
Sponsors
Biotronik, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic Sensitivity | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| BIOMONITOR III Participants consented and inserted with a BIOMONITOR III | 84 |
| Total | 84 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 1 |
| Overall Study | Lost to Follow-up | 1 |
| Overall Study | Mean R-wave sensing is < 0.25 mV during Pre-Holter observation period | 1 |
| Overall Study | No AF episodes detected during Pre-Holter Observation period | 49 |
| Overall Study | Physician Decision | 3 |
| Overall Study | Study closure | 13 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | BIOMONITOR III |
|---|---|
| Age, Continuous | 66.7 years STANDARD_DEVIATION 10.4 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 7 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 75 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Height | 67.8 Inches STANDARD_DEVIATION 4.8 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 11 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 8 Participants |
| Race (NIH/OMB) White | 64 Participants |
| Sex: Female, Male Female | 32 Participants |
| Sex: Female, Male Male | 52 Participants |
| Weight | 220.9 Pounds STANDARD_DEVIATION 53 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 84 |
| other Total, other adverse events | 1 / 84 |
| serious Total, serious adverse events | 1 / 84 |
Outcome results
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.
Time frame: 48 hours
Population: Participants with an evaluable Holter recording who have completed the 48 hr Holter monitor
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| BIOMONITOR III | Diagnostic Sensitivity | 90.9 percentage of participants |