Transcutaneous Regulation for Atrial Prevention in Postoperative Atrial Fibrillation Following OPCAB (TRAP-AF)
11. september 2026 opdateret af: Ruijin Hospital
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.
Studieoversigt
Status
Ikke rekrutterer endnu
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
410
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Yanjun Sun, M.D.
- Telefonnummer: +8613918484784
- E-mail: syj11595@rjh.com.cn
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Beskrivelse
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: taVNS Plus Standard Care
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.
|
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.
|
|
Ingen indgriben: Standard Care
Participants assigned to this arm will receive standard perioperative care for off-pump coronary artery bypass grafting without taVNS.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Incidence of New-Onset Postoperative Atrial Fibrillation Within 7 Days After OPCAB
Tidsramme: 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.
|
From the end of surgery through postoperative day 7
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Duration of Postoperative Atrial Fibrillation
Tidsramme: From the end of surgery through postoperative day 7
|
Total duration of postoperative atrial fibrillation episodes detected by continuous electrocardiographic monitoring during the first 7 days after surgery.
|
From the end of surgery through postoperative day 7
|
|
Change in Circulating Inflammatory Markers
Tidsramme: Baseline and postoperative 24, 72 and 120 hours
|
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.
|
Baseline and postoperative 24, 72 and 120 hours
|
|
Heart Rate Variability
Tidsramme: From the end of surgery through postoperative day 7
|
Heart rate variability will be assessed using Holter monitoring, including SDNN and RMSSD as measures of autonomic function.
|
From the end of surgery through postoperative day 7
|
|
Use of Antiarrhythmic Medication for Postoperative Atrial Fibrillation
Tidsramme: Through postoperative day 7
|
Proportion of participants requiring antiarrhythmic medication for treatment of postoperative atrial fibrillation, including drugs such as amiodarone.
|
Through postoperative day 7
|
|
Initiation of Anticoagulation for Postoperative Atrial Fibrillation
Tidsramme: Through postoperative day 7
|
Proportion of participants in whom anticoagulant therapy is initiated because of postoperative atrial fibrillation.
|
Through postoperative day 7
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Anslået)
1. oktober 2026
Primær færdiggørelse (Anslået)
1. oktober 2027
Studieafslutning (Anslået)
1. oktober 2027
Datoer for studieregistrering
Først indsendt
11. september 2026
Først indsendt, der opfyldte QC-kriterier
11. september 2026
Først opslået (Faktiske)
17. september 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
17. september 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
11. september 2026
Sidst verificeret
1. september 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2025575
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
JA
IPD-planbeskrivelse
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.
IPD-delingstidsramme
Beginning 6 months after publication of the primary study results and remaining available for 5 years.
IPD-delingsadgangskriterier
Deidentified individual participant data and the specified supporting information will be made available to qualified researchers who submit a methodologically sound proposal for scientifically valid analyses.
Requests will be reviewed by the principal investigator and study team.
Access will be granted subject to applicable institutional, ethical, and privacy requirements and, where appropriate, completion of a data-use agreement.
Data will be provided only for the purposes approved in the request.
IPD-deling Understøttende informationstype
- STUDY_PROTOCOL
- SAP
- ICF
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