Transcutaneous Regulation for Atrial Prevention in Postoperative Atrial Fibrillation Following OPCAB (TRAP-AF)
11. september 2026 oppdatert av: 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.
Studieoversikt
Status
Har ikke rekruttert ennå
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Antatt)
410
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Yanjun Sun, M.D.
- Telefonnummer: +8613918484784
- E-post: syj11595@rjh.com.cn
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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 inngripen: Standard Care
Participants assigned to this arm will receive standard perioperative care for off-pump coronary artery bypass grafting without taVNS.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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 |
Tiltaksbeskrivelse |
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
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Antatt)
1. oktober 2026
Primær fullføring (Antatt)
1. oktober 2027
Studiet fullført (Antatt)
1. oktober 2027
Datoer for studieregistrering
Først innsendt
11. september 2026
Først innsendt som oppfylte QC-kriteriene
11. september 2026
Først lagt ut (Faktiske)
17. september 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
17. september 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
11. september 2026
Sist bekreftet
1. september 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 2025575
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (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.
Tilgangskriterier for IPD-deling
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 Støtteinformasjonstype
- STUDY_PROTOCOL
- SEVJE
- ICF
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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