Atrial FibrillationTraP-AFNCT03392649
Tragus Stimulation to Prevent Atrial Fibrillation After Cardiac Surgery
A study testing Parasym in people with Atrial Fibrillation, run by University of Chicago at 1 site in United States.
Trial summary
Patients undergoing cardiac surgery, specifically a coronary artery bypass graft and/or heart valve replacement surgery, are at a higher risk for post-procedure atrial fibrillation (AF). AF is a condition in which the upper chambers of the heart do not contract normally and results in an irregular heartbeat. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Parasym
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Mar 2018to 31 Jul 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients ≥18 years of age, <90 years of age
- Estimated life expectancy of at least 1 year at the time of enrollment
- History of sinus rhythm or paroxysmal atrial fibrillation
Who cannot join
- Patients ≥90 years of age, <18 years
- Patients with known prior history of persistent or permanent AF
- Atrial Fibrillation occurrence within the last 24 hours of procedure
- Urgent or Emergency cases
- Pregnant patients
- Patients undergoing the following cardiac procedures: heart transplant, pulmonary thromboendarterectomy, isolated aortic arch procedures, congenital hear disease, ventricular assist device insertion, extracorporeal membrane oxygenation insertion, and surgical AF ablation
Show all 9Show fewer
- Antiarrhythmics prior to surgery (Class I and Class III)
- High degree atrioventricular block requiring temporary pacing
- Prior maze procedure for the treatment of AF
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Tragus Stimulation to Prevent Atrial Fibrillation After Cardiac Surgery: The TraP-AF Study
Patients undergoing cardiac surgery, specifically a coronary artery bypass graft and/or heart valve replacement surgery, are at a higher risk for post-procedure atrial fibrillation (AF). AF is a condition in which the upper chambers of the heart do not contract normally and results in an irregular heartbeat. Recent studies have shown that tragus stimulation decreases the likelihood of AF in animals and humans. It has also been shown to reduce inflammation which may be related to post-procedure AF. Tragus stimulation involves stimulating a part of the outer ear, called the tragus, by sending a microcurrent through a small alligator clip. It is believed that tragus stimulation can affect the nervous system, which may reduce heart rate and lead to prevention of AF. The purpose of this study is to determine whether tragus stimulation in subjects undergoing cardiac surgery will lead to shorter occurrences, or even prevention, of AF.
Read the detailed description
This was a single-blind study where patients were randomized tragus stimulation versus sham procedure and remained blinded to their treatment allocation. Both treatment options utilized similar equipment, namely the use of alligator clips which will be placed on the tragus and earlobe of the right ear for patients.
Prior to cardiac surgery, the discomfort threshold of both left and right tragus stimulation was determined for all participating patients. Intermittent electrode signals, or microcurrents, were delivered at 20 Hz with100 µsec pulse width with variable microampere (mA) output. The discomfort threshold was defined as the stimulation intensity in mA at which point patients experience discomfort. The stimulation intensity used in the study was set below the sensation and discomfort threshold. The clip was placed on the patient's ear at the end of surgery. Stimulation then continued, one ear alternating with the other, every 4 hours for a total of 48 hours. If the patient showed any sign of discomfort from stimulation, the intensity of stimulation was reduced to a level at which signs of discomfort disappears.
Follow-up was performed with a 14-day event monitor at the time of discharge, as clinically indicated. Echocardiography were assessed prior to study initiation and when clinically available in follow-up.
- Conditions
- Atrial Fibrillation
- Being tested
- Parasym
- Keywords
- Postoperative Atrial Fibrillation, Tragus Stimulation
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ParasymDevice
Tragus stimulation was done using the Parasym device.
| Study group | Role | What they receive |
|---|---|---|
| Sham Group | No intervention | 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. |
| Stimulation Group | Experimental | 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. Receives: Device: Parasym |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to the First Episode of Atrial Fibrillation (AF) >30 Seconds
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.
Measured: From end of surgery to end of hospitalization, up to 1 month.
Number of Participants Hospitalized for >5 Days
Number of participants with an overall length of hospitalization greater than five days.
Measured: From end of surgery to end of hospitalization, up to 1 month.
Secondary outcomes (6)
Overall Atrial Fibrillation (AF) Burden
The total number of hours of atrial fibrillation (AF) burden as an inpatient.
Measured: From end of surgery to end of hospitalization, up to 1 month.
Number of Participants With Rate Control Medications Used for AF
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.
Measured: From end of surgery to end of hospitalization, up to 1 month.
Number of Participants With Antiarrhythmic Used to Treat AF
Number of participants that antiarrhythmic was use to treat atrial fibrillation (i.e., use of amiodarone)
Measured: From end of surgery to end of hospitalization, up to 1 month.
Number of Participants With Inotropes Used for Blood Pressure Support During AF
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
Measured: From end of surgery to end of hospitalization, up to 1 month.
Number of Participants With Stroke or Transient Ischemic Attack (TIA)
The number of participants who suffered from a cerebral vascular accident (CVA) or transient ischemic attacks (TIA) for any cause during hospitalization was recorded.
Measured: From end of surgery to end of hospitalization, up to 1 month.
All-cause Mortality
Number of participants who suffered from mortality due to any cause during the inpatient period
Measured: From end of surgery to end of hospitalization, up to 1 month.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2018
- Study start9 Mar 2018
- Primary completion30 Jul 2021
- Study completion31 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- Parasym Ltd.
- Responsible party
- Sponsor
- Investigators
- Gaurav A. Upadhyay, MD, Principal investigator, University of ChicagoRoderick Tung, MD, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03392649
- Sponsor's protocol ID
- IRB17-1365
- Acronym
- TraP-AF
- Status last verified
- Jul 2022
- First submitted
- 2 Jan 2018
- Last updated
- 4 Aug 2022
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tragus Stimulation to Prevent Atrial Fibrillation After Cardiac Surgery: The TraP-AF Study
- ClinicalTrials.gov ID
- NCT03392649
- Acronym / sponsor ID
- TraP-AF / IRB17-1365
- Conditions
- Atrial Fibrillation
- Keywords
- Postoperative Atrial Fibrillation, Tragus Stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Collaborators
- Parasym Ltd.
- Study start
- 9 Mar 2018 (actual)
- Primary completion
- 30 Jul 2021 (actual)
- Study completion
- 31 Jul 2021 (actual)
- First posted
- 8 Jan 2018 (actual)
- Results
- Posted 4 Aug 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients undergoing cardiac surgery, specifically a coronary artery bypass graft and/or heart valve replacement surgery, are at a higher risk for post-procedure atrial fibrillation (AF). AF is a condition in which the upper chambers of the heart do not contract normally and results in an irregular heartbeat. Recent studies have shown that tragus stimulation decreases the likelihood of AF in animals and humans. It has also been shown to reduce inflammation which may be related to post-procedure AF. Tragus stimulation involves stimulating a part of the outer ear, called the tragus, by sending a microcurrent through a small alligator clip. It is believed that tragus stimulation can affect the nervous system, which may reduce heart rate and lead to prevention of AF. The purpose of this study is to determine whether tragus stimulation in subjects undergoing cardiac surgery will lead to shorter occurrences, or even prevention, of AF.
Detailed description
This was a single-blind study where patients were randomized tragus stimulation versus sham procedure and remained blinded to their treatment allocation. Both treatment options utilized similar equipment, namely the use of alligator clips which will be placed on the tragus and earlobe of the right ear for patients.
Prior to cardiac surgery, the discomfort threshold of both left and right tragus stimulation was determined for all participating patients. Intermittent electrode signals, or microcurrents, were delivered at 20 Hz with100 µsec pulse width with variable microampere (mA) output. The discomfort threshold was defined as the stimulation intensity in mA at which point patients experience discomfort. The stimulation intensity used in the study was set below the sensation and discomfort threshold. The clip was placed on the patient's ear at the end of surgery. Stimulation then continued, one ear alternating with the other, every 4 hours for a total of 48 hours. If the patient showed any sign of discomfort from stimulation, the intensity of stimulation was reduced to a level at which signs of discomfort disappears.
Follow-up was performed with a 14-day event monitor at the time of discharge, as clinically indicated. Echocardiography were assessed prior to study initiation and when clinically available in follow-up.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sham Group | No intervention | –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. |
| Stimulation Group | Experimental | Device: ParasymAt 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. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients ≥18 years of age, <90 years of age
- Estimated life expectancy of at least 1 year at the time of enrollment
- History of sinus rhythm or paroxysmal atrial fibrillation
Key exclusion criteria (9 listed)
- Patients ≥90 years of age, <18 years
- Patients with known prior history of persistent or permanent AF
- Atrial Fibrillation occurrence within the last 24 hours of procedure
- Urgent or Emergency cases
- Pregnant patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ParasymTragus stimulation was done using the Parasym device. | Device | Stimulation Group |
Primary outcome
Time to the First Episode of Atrial Fibrillation (AF) >30 Seconds
Time frame: 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.
Number of Participants Hospitalized for >5 Days
Time frame: 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.
6 secondary outcomes
Overall Atrial Fibrillation (AF) Burden
Time frame: From end of surgery to end of hospitalization, up to 1 month.
Number of Participants With Rate Control Medications Used for AF
Time frame: From end of surgery to end of hospitalization, up to 1 month.
Number of Participants With Antiarrhythmic Used to Treat AF
Time frame: From end of surgery to end of hospitalization, up to 1 month.
Number of Participants With Inotropes Used for Blood Pressure Support During AF
Time frame: From end of surgery to end of hospitalization, up to 1 month.
Number of Participants With Stroke or Transient Ischemic Attack (TIA)
Time frame: From end of surgery to end of hospitalization, up to 1 month.
All-cause Mortality
Time frame: From end of surgery to end of hospitalization, up to 1 month.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Atrial Fibrillation
Active, not recruiting
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
Concomitant Procedures, Atrial Fibrillation
Active, not recruiting
CONVERGE Post-Approval Study (PAS)
Chronic Atrial Fibrillation
Recruiting
Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
Ischemic Stroke, Atrial Fibrillation
RecruitingPhase 2
Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
Atrial Fibrillation (AF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gaurav A. Upadhyay, MD principal investigator
University of Chicago
Roderick Tung, MD principal investigator
University of Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Parasym in people with Atrial Fibrillation, run by University of Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Aug 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to the First Episode of Atrial Fibrillation (AF) >30 Seconds (time frame: From end of surgery to end of hospitalization, up to 1 month.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2022.