Transcutaneous Regulation for Atrial Prevention in Postoperative Atrial Fibrillation Following OPCAB (TRAP-AF)
11 septembre 2026 mis à jour par: 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.
Aperçu de l'étude
Statut
Pas encore de recrutement
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Estimé)
410
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: Yanjun Sun, M.D.
- Numéro de téléphone: +8613918484784
- E-mail: syj11595@rjh.com.cn
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Non
La description
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.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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.
|
|
Aucune intervention: Standard Care
Participants assigned to this arm will receive standard perioperative care for off-pump coronary artery bypass grafting without taVNS.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Incidence of New-Onset Postoperative Atrial Fibrillation Within 7 Days After OPCAB
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Duration of Postoperative Atrial Fibrillation
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: Through postoperative day 7
|
Proportion of participants in whom anticoagulant therapy is initiated because of postoperative atrial fibrillation.
|
Through postoperative day 7
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Estimé)
1 octobre 2026
Achèvement primaire (Estimé)
1 octobre 2027
Achèvement de l'étude (Estimé)
1 octobre 2027
Dates d'inscription aux études
Première soumission
11 septembre 2026
Première soumission répondant aux critères de contrôle qualité
11 septembre 2026
Première publication (Réel)
17 septembre 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
17 septembre 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
11 septembre 2026
Dernière vérification
1 septembre 2026
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 2025575
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
OUI
Description du régime IPD
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.
Délai de partage IPD
Beginning 6 months after publication of the primary study results and remaining available for 5 years.
Critères d'accès au partage IPD
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.
Type d'informations de prise en charge du partage d'IPD
- PROTOCOLE D'ÉTUDE
- SÈVE
- CIF
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
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