NCT07824492Not yet recruiting
Transcutaneous Regulation for Atrial Prevention in Postoperative Atrial Fibrillation Following OPCAB
A Single-Center, Randomized, Open-Label Study of Transcutaneous Regulation for Atrial Prevention in Postoperative Atrial Fibrillation Following OPCAB
Source: ClinicalTrials.gov · Last updated 17 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 410 (estimated)
- First submitted
- 11 Sept 2026
- Start date
- 1 Oct 2026
- Primary completion date
- Oct 2027
- Lead sponsor
- Ruijin Hospital
- Diseases
- Atrial fibrillation
- NCT number
- NCT07824492
What you commit to
- Study type: Interventional
- Planned participants: 410
- From 1 Oct 2026 to the primary completion date, Oct 2027
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Emergency OPCAB surgery or intraoperative conversion to on-pump coronary artery bypass grafting.
- Concomitant cardiac surgery, such as valve surgery, or hybrid cardiac procedures.
Other illness
- History of atrial fibrillation or other arrhythmias requiring antiarrhythmic therapy.
- 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.
Other
- Expected survival of less than 12 months or inability to complete follow-up.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.