Atrial Fibrillation (AF)TRAP-AFNCT07824492
Transcutaneous Regulation for Atrial Prevention in Postoperative Atrial Fibrillation Following OPCAB
A study testing Transcutaneous Auricular Vagus Nerve Stimulation in people with Atrial Fibrillation (AF) and OPCABG, run by Ruijin Hospital.
Trial summary
Postoperative atrial fibrillation (POAF) is a common complication after coronary artery bypass surgery and may be associated with prolonged hospitalization and adverse cardiovascular outcomes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation (AF), OPCABG
- What is being tested?
- Transcutaneous Auricular Vagus Nerve Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 410 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2026to Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or older.
- Scheduled to undergo elective off-pump coronary artery bypass grafting (OPCAB) for coronary artery disease with multivessel coronary artery disease.
- Sinus rhythm on the preoperative baseline electrocardiogram, with no history of atrial fibrillation or other clinically significant arrhythmias.
- Able and willing to provide written informed consent and comply with the study intervention and follow-up procedures.
- Expected postoperative hospital stay of at least 7 days to allow postoperative atrial fibrillation monitoring.
Who cannot join
- History of atrial fibrillation or other arrhythmias requiring antiarrhythmic therapy.
- Emergency OPCAB surgery or intraoperative conversion to on-pump coronary artery bypass grafting.
- Concomitant cardiac surgery, such as valve surgery, or hybrid cardiac procedures.
- Vagus nerve-related disorders, epilepsy, active ear infection, or implanted electrical devices such as a pacemaker or implantable cardioverter-defibrillator.
- Severe comorbidities, including severe renal dysfunction (estimated glomerular filtration rate <30 mL/min/1.73 m²), active malignancy, current immunosuppressive therapy, or chronic inflammatory disease.
- Inability to tolerate auricular stimulation, including significant skin allergy or intolerance, or anticipated poor adherence to the study procedures.
- Expected survival of less than 12 months or inability to complete follow-up.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Single-Center, Randomized, Open-Label Study of Transcutaneous Regulation for Atrial Prevention in Postoperative Atrial Fibrillation Following OPCAB
Postoperative atrial fibrillation (POAF) is a common complication after coronary artery bypass surgery and may be associated with prolonged hospitalization and adverse cardiovascular outcomes. Transcutaneous auricular vagus nerve stimulation (taVNS) is a noninvasive neuromodulation technique that delivers mild electrical stimulation to the ear and may help regulate autonomic and inflammatory responses.
This randomized controlled trial will evaluate whether perioperative taVNS can reduce the incidence of POAF in adults undergoing elective off-pump coronary artery bypass grafting (OPCAB). Participants will be randomly assigned in a 1:1 ratio to receive either taVNS in addition to standard perioperative care or standard perioperative care alone. The primary outcome is the incidence of new-onset atrial fibrillation within 7 days after surgery. Secondary outcomes will include atrial fibrillation burden, inflammatory markers, heart rate variability, use of antiarrhythmic and anticoagulant medications, safety, length of hospital stay, and major adverse cardiovascular events during follow-up.
- Conditions
- Atrial Fibrillation (AF), OPCABG
- Being tested
- Transcutaneous Auricular Vagus Nerve 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.
Transcutaneous Auricular Vagus Nerve StimulationDevice
Transcutaneous auricular vagus nerve stimulation (taVNS) will be delivered using the taVNS device. Stimulation will be applied to the left auricular region targeting the auricular branch of the vagus nerve. The stimulation frequency will be 20 Hz with a pulse width of approximately 200 μs. Stimulation intensity will be gradually increased from zero to the highest level that is comfortably tolerated without pain. Participants will receive two stimulation sessions per day, separated by at least 4-6 hours, beginning 1 days before surgery and continuing through postoperative day 7. Each session will last 60 minutes. Standard perioperative care for off-pump coronary artery bypass grafting will be provided concurrently.
| Study group | Role | What they receive |
|---|---|---|
| taVNS Plus Standard Care | Experimental | Participants assigned to this arm will receive perioperative transcutaneous auricular vagus nerve stimulation (taVNS) in addition to standard perioperative care for off-pump coronary artery bypass grafting. Receives: Device: Transcutaneous Auricular Vagus Nerve Stimulation |
| Standard Care | No intervention | Participants assigned to this arm will receive standard perioperative care for off-pump coronary artery bypass grafting without taVNS. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of New-Onset Postoperative Atrial Fibrillation Within 7 Days After OPCAB
The proportion of participants who develop new-onset postoperative atrial fibrillation (POAF) after off-pump coronary artery bypass grafting. POAF is defined as an episode of atrial fibrillation lasting at least 30 seconds, detected by continuous electrocardiographic monitoring, Holter monitoring, or telemetry. Events will be adjudicated by outcome assessors blinded to treatment allocation.
Measured: From the end of surgery through postoperative day 7
Secondary outcomes (5)
Duration of Postoperative Atrial Fibrillation
Total duration of postoperative atrial fibrillation episodes detected by continuous electrocardiographic monitoring during the first 7 days after surgery.
Measured: From the end of surgery through postoperative day 7
Change in Circulating Inflammatory Markers
Changes in serum interleukin-6 (IL-6), tumor necrosis factor-alpha (TNF-α), and C-reactive protein (CRP) levels will be assessed to evaluate the perioperative inflammatory response.
Measured: Baseline and postoperative 24, 72 and 120 hours
Heart Rate Variability
Heart rate variability will be assessed using Holter monitoring, including SDNN and RMSSD as measures of autonomic function.
Measured: From the end of surgery through postoperative day 7
Use of Antiarrhythmic Medication for Postoperative Atrial Fibrillation
Proportion of participants requiring antiarrhythmic medication for treatment of postoperative atrial fibrillation, including drugs such as amiodarone.
Measured: Through postoperative day 7
Initiation of Anticoagulation for Postoperative Atrial Fibrillation
Proportion of participants in whom anticoagulant therapy is initiated because of postoperative atrial fibrillation.
Measured: Through postoperative day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2026
- Study start1 Oct 2026 (estimated)
- Primary completionOct 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial Fibrillation (AF)Studies of the same condition, open and under way.
- More trials run by Ruijin HospitalThe 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
- None (open label)
- Enrolment
- 410 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07824492
- Sponsor's protocol ID
- 2025575
- Acronym
- TRAP-AF
- Status last verified
- Sep 2026
- First submitted
- 11 Sep 2026
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified individual participant data that underlie the results reported in the primary publication may be shared with qualified researchers upon reasonable request. Requests will be reviewed by the study investigators and will require a methodologically sound proposal and appropriate data-use agreements. Data sharing will be subject to applicable ethical, institutional, and privacy requirements.
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Center, Randomized, Open-Label Study of Transcutaneous Regulation for Atrial Prevention in Postoperative Atrial Fibrillation Following OPCAB
- ClinicalTrials.gov ID
- NCT07824492
- Acronym / sponsor ID
- TRAP-AF / 2025575
- Conditions
- Atrial Fibrillation (AF), OPCABG
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 410 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 17 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Postoperative atrial fibrillation (POAF) is a common complication after coronary artery bypass surgery and may be associated with prolonged hospitalization and adverse cardiovascular outcomes. Transcutaneous auricular vagus nerve stimulation (taVNS) is a noninvasive neuromodulation technique that delivers mild electrical stimulation to the ear and may help regulate autonomic and inflammatory responses.
This randomized controlled trial will evaluate whether perioperative taVNS can reduce the incidence of POAF in adults undergoing elective off-pump coronary artery bypass grafting (OPCAB). Participants will be randomly assigned in a 1:1 ratio to receive either taVNS in addition to standard perioperative care or standard perioperative care alone. The primary outcome is the incidence of new-onset atrial fibrillation within 7 days after surgery. Secondary outcomes will include atrial fibrillation burden, inflammatory markers, heart rate variability, use of antiarrhythmic and anticoagulant medications, safety, length of hospital stay, and major adverse cardiovascular events during follow-up.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| taVNS Plus Standard Care | Experimental | Device: Transcutaneous Auricular Vagus Nerve StimulationParticipants assigned to this arm will receive perioperative transcutaneous auricular vagus nerve stimulation (taVNS) in addition to standard perioperative care for off-pump coronary artery bypass grafting. |
| Standard Care | No intervention | –Participants assigned to this arm will receive standard perioperative care for off-pump coronary artery bypass grafting without taVNS. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18 years or older.
- Scheduled to undergo elective off-pump coronary artery bypass grafting (OPCAB) for coronary artery disease with multivessel coronary artery disease.
- Sinus rhythm on the preoperative baseline electrocardiogram, with no history of atrial fibrillation or other clinically significant arrhythmias.
- Able and willing to provide written informed consent and comply with the study intervention and follow-up procedures.
- Expected postoperative hospital stay of at least 7 days to allow postoperative atrial fibrillation monitoring.
Key exclusion criteria (7 listed)
- History of atrial fibrillation or other arrhythmias requiring antiarrhythmic therapy.
- Emergency OPCAB surgery or intraoperative conversion to on-pump coronary artery bypass grafting.
- Concomitant cardiac surgery, such as valve surgery, or hybrid cardiac procedures.
- Vagus nerve-related disorders, epilepsy, active ear infection, or implanted electrical devices such as a pacemaker or implantable cardioverter-defibrillator.
- Severe comorbidities, including severe renal dysfunction (estimated glomerular filtration rate <30 mL/min/1.73 m²), active malignancy, current immunosuppressive therapy, or chronic inflammatory disease.
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 |
|---|---|---|
| Transcutaneous Auricular Vagus Nerve StimulationTranscutaneous auricular vagus nerve stimulation (taVNS) will be delivered using the taVNS device. Stimulation will be applied to the left auricular region targeting the auricular branch of the vagus nerve. The stimulation frequency will be 20 Hz with a pulse width of approximately 200 μs. Stimulation intensity will be gradually increased from zero to the highest level that is comfortably tolerated without pain. Participants will receive two stimulation sessions per day, separated by at least 4-6 hours, beginning 1 days before surgery and continuing through postoperative day 7. Each session will last 60 minutes. Standard perioperative care for off-pump coronary artery bypass grafting will be provided concurrently. | Device | taVNS Plus Standard Care |
Primary outcome
Incidence of New-Onset Postoperative Atrial Fibrillation Within 7 Days After OPCAB
Time frame: From the end of surgery through postoperative day 7
The proportion of participants who develop new-onset postoperative atrial fibrillation (POAF) after off-pump coronary artery bypass grafting. POAF is defined as an episode of atrial fibrillation lasting at least 30 seconds, detected by continuous electrocardiographic monitoring, Holter monitoring, or telemetry. Events will be adjudicated by outcome assessors blinded to treatment allocation.
5 secondary outcomes
Duration of Postoperative Atrial Fibrillation
Time frame: From the end of surgery through postoperative day 7
Change in Circulating Inflammatory Markers
Time frame: Baseline and postoperative 24, 72 and 120 hours
Heart Rate Variability
Time frame: From the end of surgery through postoperative day 7
Use of Antiarrhythmic Medication for Postoperative Atrial Fibrillation
Time frame: Through postoperative day 7
Initiation of Anticoagulation for Postoperative Atrial Fibrillation
Time frame: Through postoperative day 7
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
- Individual participant dataSharing planned: Yes. Deidentified individual participant data that underlie the results reported in the primary publication may be shared with qualified researchers upon reasonable request. Requests will be reviewed by the study investigators and will require a methodologically sound proposal and appropriate data-use agreements. Data sharing will be subject to applicable ethical, institutional, and privacy requirements.
Related trials for Atrial Fibrillation (AF)
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 recruiting
CONVERGE Post-Approval Study (PAS)
Chronic Atrial Fibrillation
RecruitingPhase 2
Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
Atrial Fibrillation (AF)
RecruitingPhase 3
Stroke and Systemic Embolism Prevention in Adult Participants With Atrial Fibrillation
Atrial Fibrillation (AF)
Not yet recruitingObservational study
Hummingbird ICE Study
ATRIAL APPENDAGE CLOSURE for ATRIAL FIBRILLATION, 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.
Questions about this trial
What is this clinical trial studying?
A study testing Transcutaneous Auricular Vagus Nerve Stimulation in people with Atrial Fibrillation (AF) and OPCABG, run by Ruijin Hospital.
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 5 inclusion and 7 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: opening soon, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yanjun Sun, M.D. (+8613918484784, syj11595@rjh.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of New-Onset Postoperative Atrial Fibrillation Within 7 Days After OPCAB (time frame: From the end of surgery through postoperative day 7). 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 17 Sep 2026.