Trial Outcomes & Findings for Tragus Stimulation to Prevent Atrial Fibrillation After Cardiac Surgery (NCT NCT03392649)
NCT ID: NCT03392649
Last Updated: 2022-08-04
Results Overview
Time to the first episode of atrial fibrillation (AF) that was greater than 30 seconds in patients who had AF. This was assessed on the review of patient chart and inpatient telemetry.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
81 participants
Primary outcome timeframe
From end of surgery to end of hospitalization, up to 1 month.
Results posted on
2022-08-04
Participant Flow
Subjects were recruited from the University of Chicago Medical Center
Participant milestones
| Measure |
Stimulation Group
At the end of cardiac surgery, the Parasym alligator clip was placed on the subject's tragus, and the subject received continuous stimulation for 48 hours. The clip was switched to the other ear every 4 hours.
Parasym: Tragus stimulation has been done using the Parasym device.
|
Sham Group
At the end of cardiac surgery, the Parasym alligator clip was placed on the subject's tragus, but the Parasym was not turned on and the subject did not receive any stimulation. The clip was switched to the other ear every 4 hours for a total of 48 hours.
|
|---|---|---|
|
Overall Study
STARTED
|
40
|
41
|
|
Overall Study
COMPLETED
|
40
|
41
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Tragus Stimulation to Prevent Atrial Fibrillation After Cardiac Surgery
Baseline characteristics by cohort
| Measure |
Stimulation Group
n=40 Participants
At the end of cardiac surgery, the Parasym alligator clip was placed on the subject's tragus, and the subject received continuous stimulation for 48 hours. The clip was switched to the other ear every 4 hours.
Parasym: Tragus stimulation was done using the Parasym device.
|
Sham Group
n=41 Participants
At the end of cardiac surgery, the Parasym alligator clip was placed on the subject's tragus, but the Parasym was not turned on, and the subject did not receive any stimulation. The clip was switched to the other ear every 4 hours for a total of 48 hours.
|
Total
n=81 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
67.0 years
n=5 Participants
|
65.0 years
n=7 Participants
|
66.0 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
28 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
62 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
27 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
59 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · African American
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Others
|
9 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Height(cm)
|
172.7 cm
n=5 Participants
|
177.8 cm
n=7 Participants
|
173 cm
n=5 Participants
|
|
Weight(kg)
|
79.4 kg
n=5 Participants
|
92.3 kg
n=7 Participants
|
83.5 kg
n=5 Participants
|
|
Body Mass Index
|
28.17 kg/m^2
n=5 Participants
|
28.75 kg/m^2
n=7 Participants
|
28.56 kg/m^2
n=5 Participants
|
|
NYHA Class
Class I
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
NYHA Class
Class II
|
10 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
NYHA Class
Class III
|
21 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
NYHA Class
No heart failure symptoms noted
|
9 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Diabetes Mellitus
|
14 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Hypertension
|
32 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
61 Participants
n=5 Participants
|
|
History of stroke or transient ischemic attack
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Peripheral arterial disease
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Creatinine
|
1.1 micromoles/L
n=5 Participants
|
0.9 micromoles/L
n=7 Participants
|
1.0 micromoles/L
n=5 Participants
|
|
Chronic kidney disease
|
12 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
End-stage renal disease
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Beta-blocker
|
26 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Calcium channel blocker
|
13 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Angiotensin converting enzyme inhibition or receptor blockade
|
22 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Aldosterone blockade
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Digoxin
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Totally-endoscopic coronary artery bypass (TECAB)
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Coronary artery bypass graft surgery (CABG)
|
25 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From end of surgery to end of hospitalization, up to 1 month.Time to the first episode of atrial fibrillation (AF) that was greater than 30 seconds in patients who had AF. This was assessed on the review of patient chart and inpatient telemetry.
Outcome measures
| Measure |
Stimulation Group
n=40 Participants
At the end of cardiac surgery, the Parasym alligator clip was placed on the subject's tragus, and the subject received continuous stimulation for 48 hours. The clip was switched to the other ear every 4 hours.
Parasym: Tragus stimulation has been done using the Parasym device.
|
Sham Group
n=41 Participants
At the end of cardiac surgery, the Parasym alligator clip was placed on the subject's tragus, but the Parasym was not turned on and the subject did not receive any stimulation. The clip has been switched to the other ear every 4 hours for a total of 48 hours.
|
|---|---|---|
|
Time to the First Episode of Atrial Fibrillation (AF) >30 Seconds
|
53.1 hours
Interval 39.8 to 77.3
|
52.2 hours
Interval 28.7 to 62.3
|
PRIMARY outcome
Timeframe: From end of surgery to end of hospitalization, up to 1 month.Number of participants with an overall length of hospitalization greater than five days.
Outcome measures
| Measure |
Stimulation Group
n=40 Participants
At the end of cardiac surgery, the Parasym alligator clip was placed on the subject's tragus, and the subject received continuous stimulation for 48 hours. The clip was switched to the other ear every 4 hours.
Parasym: Tragus stimulation has been done using the Parasym device.
|
Sham Group
n=41 Participants
At the end of cardiac surgery, the Parasym alligator clip was placed on the subject's tragus, but the Parasym was not turned on and the subject did not receive any stimulation. The clip has been switched to the other ear every 4 hours for a total of 48 hours.
|
|---|---|---|
|
Number of Participants Hospitalized for >5 Days
|
25 Participants
|
22 Participants
|
SECONDARY outcome
Timeframe: From end of surgery to end of hospitalization, up to 1 month.The total number of hours of atrial fibrillation (AF) burden as an inpatient.
Outcome measures
| Measure |
Stimulation Group
n=40 Participants
At the end of cardiac surgery, the Parasym alligator clip was placed on the subject's tragus, and the subject received continuous stimulation for 48 hours. The clip was switched to the other ear every 4 hours.
Parasym: Tragus stimulation has been done using the Parasym device.
|
Sham Group
n=41 Participants
At the end of cardiac surgery, the Parasym alligator clip was placed on the subject's tragus, but the Parasym was not turned on and the subject did not receive any stimulation. The clip has been switched to the other ear every 4 hours for a total of 48 hours.
|
|---|---|---|
|
Overall Atrial Fibrillation (AF) Burden
|
24.7 hours
Interval 7.6 to 50.6
|
27.3 hours
Interval 12.0 to 89.3
|
SECONDARY outcome
Timeframe: From end of surgery to end of hospitalization, up to 1 month.Number of participants that the management of their postoperative atrial fibrillation (AF) utilized the use of rate-controlling medications such as beta-blockers, calcium-channel blockers, or the use of digoxin.
Outcome measures
| Measure |
Stimulation Group
n=40 Participants
At the end of cardiac surgery, the Parasym alligator clip was placed on the subject's tragus, and the subject received continuous stimulation for 48 hours. The clip was switched to the other ear every 4 hours.
Parasym: Tragus stimulation has been done using the Parasym device.
|
Sham Group
n=41 Participants
At the end of cardiac surgery, the Parasym alligator clip was placed on the subject's tragus, but the Parasym was not turned on and the subject did not receive any stimulation. The clip has been switched to the other ear every 4 hours for a total of 48 hours.
|
|---|---|---|
|
Number of Participants With Rate Control Medications Used for AF
|
17 Participants
|
12 Participants
|
SECONDARY outcome
Timeframe: From end of surgery to end of hospitalization, up to 1 month.Number of participants that antiarrhythmic was use to treat atrial fibrillation (i.e., use of amiodarone)
Outcome measures
| Measure |
Stimulation Group
n=40 Participants
At the end of cardiac surgery, the Parasym alligator clip was placed on the subject's tragus, and the subject received continuous stimulation for 48 hours. The clip was switched to the other ear every 4 hours.
Parasym: Tragus stimulation has been done using the Parasym device.
|
Sham Group
n=41 Participants
At the end of cardiac surgery, the Parasym alligator clip was placed on the subject's tragus, but the Parasym was not turned on and the subject did not receive any stimulation. The clip has been switched to the other ear every 4 hours for a total of 48 hours.
|
|---|---|---|
|
Number of Participants With Antiarrhythmic Used to Treat AF
|
16 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: From end of surgery to end of hospitalization, up to 1 month.The number of participants who management of their postoperative atrial fibrillation (AF) required the use of inotropic vasoactive or pressor medications for blood pressure (BP) support
Outcome measures
| Measure |
Stimulation Group
n=40 Participants
At the end of cardiac surgery, the Parasym alligator clip was placed on the subject's tragus, and the subject received continuous stimulation for 48 hours. The clip was switched to the other ear every 4 hours.
Parasym: Tragus stimulation has been done using the Parasym device.
|
Sham Group
n=41 Participants
At the end of cardiac surgery, the Parasym alligator clip was placed on the subject's tragus, but the Parasym was not turned on and the subject did not receive any stimulation. The clip has been switched to the other ear every 4 hours for a total of 48 hours.
|
|---|---|---|
|
Number of Participants With Inotropes Used for Blood Pressure Support During AF
|
4 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: From end of surgery to end of hospitalization, up to 1 month.The number of participants who suffered from a cerebral vascular accident (CVA) or transient ischemic attacks (TIA) for any cause during hospitalization was recorded.
Outcome measures
| Measure |
Stimulation Group
n=40 Participants
At the end of cardiac surgery, the Parasym alligator clip was placed on the subject's tragus, and the subject received continuous stimulation for 48 hours. The clip was switched to the other ear every 4 hours.
Parasym: Tragus stimulation has been done using the Parasym device.
|
Sham Group
n=41 Participants
At the end of cardiac surgery, the Parasym alligator clip was placed on the subject's tragus, but the Parasym was not turned on and the subject did not receive any stimulation. The clip has been switched to the other ear every 4 hours for a total of 48 hours.
|
|---|---|---|
|
Number of Participants With Stroke or Transient Ischemic Attack (TIA)
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: From end of surgery to end of hospitalization, up to 1 month.Number of participants who suffered from mortality due to any cause during the inpatient period
Outcome measures
| Measure |
Stimulation Group
n=40 Participants
At the end of cardiac surgery, the Parasym alligator clip was placed on the subject's tragus, and the subject received continuous stimulation for 48 hours. The clip was switched to the other ear every 4 hours.
Parasym: Tragus stimulation has been done using the Parasym device.
|
Sham Group
n=41 Participants
At the end of cardiac surgery, the Parasym alligator clip was placed on the subject's tragus, but the Parasym was not turned on and the subject did not receive any stimulation. The clip has been switched to the other ear every 4 hours for a total of 48 hours.
|
|---|---|---|
|
All-cause Mortality
|
3 Participants
|
0 Participants
|
Adverse Events
Stimulation Group
Serious events: 1 serious events
Other events: 0 other events
Deaths: 3 deaths
Sham Group
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Stimulation Group
n=40 participants at risk
At the end of cardiac surgery, the Parasym alligator clip was placed on the subject's tragus, and the subject received continuous stimulation for 48 hours. The clip was switched to the other ear every 4 hours.
Parasym: Tragus stimulation was done using the Parasym device.
|
Sham Group
n=41 participants at risk
At the end of cardiac surgery, the Parasym alligator clip was placed on the subject's tragus, but the Parasym was not turned on and the subject did not receive any stimulation. The clip has been switched to the other ear every 4 hours for a total of 48 hours.
|
|---|---|---|
|
Vascular disorders
Stroke or Transient Ischemic Attack (TIA)
|
2.5%
1/40 • From the end of the surgery to the end of hospitalization, up to 1 month.
|
2.4%
1/41 • From the end of the surgery to the end of hospitalization, up to 1 month.
|
Other adverse events
| Measure |
Stimulation Group
n=40 participants at risk
At the end of cardiac surgery, the Parasym alligator clip was placed on the subject's tragus, and the subject received continuous stimulation for 48 hours. The clip was switched to the other ear every 4 hours.
Parasym: Tragus stimulation was done using the Parasym device.
|
Sham Group
n=41 participants at risk
At the end of cardiac surgery, the Parasym alligator clip was placed on the subject's tragus, but the Parasym was not turned on and the subject did not receive any stimulation. The clip has been switched to the other ear every 4 hours for a total of 48 hours.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Skin abrasion
|
0.00%
0/40 • From the end of the surgery to the end of hospitalization, up to 1 month.
|
2.4%
1/41 • Number of events 1 • From the end of the surgery to the end of hospitalization, up to 1 month.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place