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Transcutaneous Regulation for Atrial Prevention in Postoperative Atrial Fibrillation Following OPCAB (TRAP-AF)

11 september 2026 bijgewerkt door: 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.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Geschat)

410

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

Inclusion Criteria:

  1. Age 18 years or older.
  2. Scheduled to undergo elective off-pump coronary artery bypass grafting (OPCAB) for coronary artery disease with multivessel coronary artery disease.
  3. Sinus rhythm on the preoperative baseline electrocardiogram, with no history of atrial fibrillation or other clinically significant arrhythmias.
  4. Able and willing to provide written informed consent and comply with the study intervention and follow-up procedures.
  5. Expected postoperative hospital stay of at least 7 days to allow postoperative atrial fibrillation monitoring.

Exclusion Criteria:

  1. History of atrial fibrillation or other arrhythmias requiring antiarrhythmic therapy.
  2. Emergency OPCAB surgery or intraoperative conversion to on-pump coronary artery bypass grafting.
  3. Concomitant cardiac surgery, such as valve surgery, or hybrid cardiac procedures.
  4. Vagus nerve-related disorders, epilepsy, active ear infection, or implanted electrical devices such as a pacemaker or implantable cardioverter-defibrillator.
  5. 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.
  6. Inability to tolerate auricular stimulation, including significant skin allergy or intolerance, or anticipated poor adherence to the study procedures.
  7. Expected survival of less than 12 months or inability to complete follow-up.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Preventie
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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.
Apparaat: Transcutaneous Auricular Vagus Nerve Stimulation
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.
Geen tussenkomst: Standard Care
Participants assigned to this arm will receive standard perioperative care for off-pump coronary artery bypass grafting without taVNS.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Incidence of New-Onset Postoperative Atrial Fibrillation Within 7 Days After OPCAB
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Duration of Postoperative Atrial Fibrillation
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: Through postoperative day 7
Proportion of participants in whom anticoagulant therapy is initiated because of postoperative atrial fibrillation.
Through postoperative day 7

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Ruijin Hospital

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 oktober 2026

Primaire voltooiing (Geschat)

1 oktober 2027

Studie voltooiing (Geschat)

1 oktober 2027

Studieregistratiedata

Eerst ingediend

11 september 2026

Eerst ingediend dat voldeed aan de QC-criteria

11 september 2026

Eerst geplaatst (Werkelijk)

17 september 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

17 september 2026

Laatste update ingediend die voldeed aan QC-criteria

11 september 2026

Laatst geverifieerd

1 september 2026

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 2025575

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

JA

Beschrijving IPD-plan

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-tijdsbestek voor delen

Beginning 6 months after publication of the primary study results and remaining available for 5 years.

IPD-toegangscriteria voor delen

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 delen Ondersteunend informatietype

  • LEERPROTOCOOL
  • SAP
  • ICF

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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