Trial Outcomes & Findings for Transcutaneous Electrical Vagus Nerve Stimulation to Suppress Atrial Fibrillation (NCT NCT02548754)
NCT ID: NCT02548754
Last Updated: 2022-02-16
Results Overview
Percent time spent in atrial fibrillation
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
53 participants
Primary outcome timeframe
6 months
Results posted on
2022-02-16
Participant Flow
Participant milestones
| Measure |
Active
Patients will receive 1 hour of active low level tragus stimulation daily for 6 months
Parasym device
|
Sham
Patients will receive 1 hour of sham low level tragus stimulation daily for 6 months
Parasym device
|
|---|---|---|
|
Overall Study
STARTED
|
26
|
27
|
|
Overall Study
COMPLETED
|
24
|
23
|
|
Overall Study
NOT COMPLETED
|
2
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Transcutaneous Electrical Vagus Nerve Stimulation to Suppress Atrial Fibrillation
Baseline characteristics by cohort
| Measure |
Active
n=26 Participants
Patients will receive 1 hour of active low level tragus stimulation daily for 6 months
Parasym device
|
Sham
n=27 Participants
Patients will receive 1 hour of sham low level tragus stimulation daily for 6 months
Parasym device
|
Total
n=53 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
65 years
STANDARD_DEVIATION 15 • n=5 Participants
|
68 years
STANDARD_DEVIATION 11 • n=7 Participants
|
67 years
STANDARD_DEVIATION 12 • n=5 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
25 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
AF burden
|
4.5 %
n=5 Participants
|
1 %
n=7 Participants
|
2.5 %
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPercent time spent in atrial fibrillation
Outcome measures
| Measure |
Active
n=26 Participants
Patients will receive 1 hour of active low level tragus stimulation daily for 6 months
Parasym device
|
Sham
n=27 Participants
Patients will receive 1 hour of sham low level tragus stimulation daily for 6 months
Parasym device
|
|---|---|---|
|
Atrial Fibrillation Burden
|
2 Percent time spent in atrial fibrillatio
Interval 0.0 to 11.0
|
8.5 Percent time spent in atrial fibrillatio
Interval 0.0 to 42.0
|
SECONDARY outcome
Timeframe: 6 monthsSerum levels of tumor necrosis factor-alpha
Outcome measures
| Measure |
Active
n=26 Participants
Patients will receive 1 hour of active low level tragus stimulation daily for 6 months
Parasym device
|
Sham
n=27 Participants
Patients will receive 1 hour of sham low level tragus stimulation daily for 6 months
Parasym device
|
|---|---|---|
|
Markers of Inflammation
|
5.5 pg/ml
Interval 3.9 to 8.3
|
5.4 pg/ml
Interval 4.4 to 8.3
|
SECONDARY outcome
Timeframe: 6 monthsSerum levels of inteleukin 6
Outcome measures
| Measure |
Active
n=26 Participants
Patients will receive 1 hour of active low level tragus stimulation daily for 6 months
Parasym device
|
Sham
n=27 Participants
Patients will receive 1 hour of sham low level tragus stimulation daily for 6 months
Parasym device
|
|---|---|---|
|
Markers of Inflammation
|
1.5 pg/ml
Interval 0.7 to 3.2
|
2.3 pg/ml
Interval 1.0 to 4.4
|
Adverse Events
Active
Serious events: 0 serious events
Other events: 0 other events
Deaths: 1 deaths
Sham
Serious events: 0 serious events
Other events: 0 other events
Deaths: 2 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Stavros Stavrakis
University of Oklahoma Health Sciences Center
Phone: 4052714742
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place