Trial Outcomes & Findings for Assessment of the Utility of BIOMONITOR to Identify Atrial Fibrillation (AF) in Ablation Candidates Using Precise AF Detection (NCT NCT04076917)
NCT ID: NCT04076917
Last Updated: 2022-04-05
Results Overview
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.
TERMINATED
84 participants
48 hours
2022-04-05
Participant Flow
Participant milestones
| Measure |
BIOMONITOR III
Participants consented and inserted with a BIOMONITOR III
|
|---|---|
|
Overall Study
STARTED
|
84
|
|
Overall Study
COMPLETED
|
15
|
|
Overall Study
NOT COMPLETED
|
69
|
Reasons for withdrawal
| Measure |
BIOMONITOR III
Participants consented and inserted with a BIOMONITOR III
|
|---|---|
|
Overall Study
No AF episodes detected during Pre-Holter Observation period
|
49
|
|
Overall Study
Study closure
|
13
|
|
Overall Study
Physician Decision
|
3
|
|
Overall Study
Death
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Mean R-wave sensing is < 0.25 mV during Pre-Holter observation period
|
1
|
Baseline Characteristics
Assessment of the Utility of BIOMONITOR to Identify Atrial Fibrillation (AF) in Ablation Candidates Using Precise AF Detection
Baseline characteristics by cohort
| Measure |
BIOMONITOR III
n=84 Participants
Participants consented and inserted with a BIOMONITOR III
|
|---|---|
|
Age, Continuous
|
66.7 years
STANDARD_DEVIATION 10.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
32 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
52 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
75 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
64 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
8 Participants
n=5 Participants
|
|
Height
|
67.8 Inches
STANDARD_DEVIATION 4.8 • n=5 Participants
|
|
Weight
|
220.9 Pounds
STANDARD_DEVIATION 53.0 • n=5 Participants
|
PRIMARY outcome
Timeframe: 48 hoursPopulation: Participants with an evaluable Holter recording who have completed the 48 hr Holter monitor
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.
Outcome measures
| Measure |
BIOMONITOR III
n=25 Participants
Participants consented and inserted with a BIOMONITOR III
|
|---|---|
|
Diagnostic Sensitivity
|
90.9 percentage of participants
Interval 71.0 to 100.0
|
Adverse Events
BIOMONITOR III
Serious adverse events
| Measure |
BIOMONITOR III
n=84 participants at risk
Participants consented and inserted with a BIOMONITOR III
|
|---|---|
|
Infections and infestations
Surgical site infection
|
1.2%
1/84 • Number of events 1 • Insertion through study exit or study termination, an average of 1.7 months, and up to 5.7 months
Sites were required to report all insertion procedure-related and device-related adverse events. Additionally, sites were required to report all non-procedure non-system related adverse events if any of the following occur and require device removal: (1) Secondary infection, and (2) Other non-elective intervention
|
Other adverse events
| Measure |
BIOMONITOR III
n=84 participants at risk
Participants consented and inserted with a BIOMONITOR III
|
|---|---|
|
Infections and infestations
Cellulitis at implant site
|
1.2%
1/84 • Number of events 1 • Insertion through study exit or study termination, an average of 1.7 months, and up to 5.7 months
Sites were required to report all insertion procedure-related and device-related adverse events. Additionally, sites were required to report all non-procedure non-system related adverse events if any of the following occur and require device removal: (1) Secondary infection, and (2) Other non-elective intervention
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place