Trial Outcomes & Findings for Comparison of the Performance of ICM and CIED in Detecting AF (NCT NCT04940156)
NCT ID: NCT04940156
Last Updated: 2024-10-15
Results Overview
To assess the performance of the Confirm Rx™ ICM and Reveal LINQ™ ICM in detecting clinically significant AF episodes (episodes longer than 6 minutes) in comparison to CIED (gold standard). Confirm Rx and Reveal LINQ™ ICM sensitivity, specificity, positive predictive value and negative predictive value will be calculated for AF episodes longer than 6 minutes.
TERMINATED
NA
6 participants
During follow-up (6 months)
2024-10-15
Participant Flow
Participant milestones
| Measure |
Confirm Rx
Patient with cardiac implantable electronic devices with an atrial lead will have Confirm Rx Implantable Cardiac Monitor injected in the anterior chest wall.
Confirm Rx (Implantable Cardiac Monitor): Confirm Rx implanted in patients with atrial fibrillation detected on their cardiac implantable electronic device (CIED)
|
LINQ
Patient with cardiac implantable electronic devices with an atrial lead will have LINQ Implantable Cardiac Monitor injected in the anterior chest wall.
Reveal LINQ (Implantable Cardiac Monitor): Reveal LINQ implanted in patients with atrial fibrillation detected on their cardiac implantable electronic device (CIED)
|
|---|---|---|
|
Overall Study
STARTED
|
5
|
1
|
|
Overall Study
COMPLETED
|
5
|
1
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Comparison of the Performance of ICM and CIED in Detecting AF
Baseline characteristics by cohort
| Measure |
Confirm Rx
n=5 Participants
Patient with cardiac implantable electronic devices with an atrial lead will have Confirm Rx Implantable Cardiac Monitor injected in the anterior chest wall.
Confirm Rx (Implantable Cardiac Monitor): Confirm Rx implanted in patients with atrial fibrillation detected on their cardiac implantable electronic device (CIED)
|
LINQ
n=1 Participants
Patient with cardiac implantable electronic devices with an atrial lead will have LINQ Implantable Cardiac Monitor injected in the anterior chest wall.
Reveal LINQ (Implantable Cardiac Monitor): Reveal LINQ implanted in patients with atrial fibrillation detected on their cardiac implantable electronic device (CIED)
|
Total
n=6 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United Kingdom
|
5 participants
n=99 Participants
|
1 participants
n=107 Participants
|
6 participants
n=206 Participants
|
|
Count of participants
|
5 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: During follow-up (6 months)Population: Data were not collected.
To assess the performance of the Confirm Rx™ ICM and Reveal LINQ™ ICM in detecting clinically significant AF episodes (episodes longer than 6 minutes) in comparison to CIED (gold standard). Confirm Rx and Reveal LINQ™ ICM sensitivity, specificity, positive predictive value and negative predictive value will be calculated for AF episodes longer than 6 minutes.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: During follow-up (6 months)Population: Data were not collected.
A comparison will be made between the percentage of change in R-wave amplitudes between both ICMs.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: During follow-up (6 months)Population: Data were not collected.
The percentage of successful transmission in both ICMs will be calculated.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: During follow-up (6 months)Population: Data were not collected.
The percentage of patient-activated recordings with symptoms attributed to those episodes will be calculated.
Outcome measures
Outcome data not reported
Adverse Events
Confirm Rx
LINQ
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place