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Partial Cardiac Denervation for Preventing Atrial Fibrillation After CABG (CALM)

31 octobre 2026 mis à jour par: China National Center for Cardiovascular Diseases

Cardiac Autonomic Neuromodulation in Myocardial Revascularization (CALM): A Multicenter Randomized Controlled Trial of Partial Cardiac Denervation for the Prevention of Postoperative Atrial Fibrillation After Coronary Artery Bypass Grafting

Postoperative atrial fibrillation (POAF) is the most common arrhythmia following cardiac surgery and is associated with increased risks of mortality, stroke, myocardial infarction, and hospital readmission. The cardiac autonomic nervous system plays an important role in the development of POAF and may represent a potential target for preventive intervention.

The CALM trial is a multicenter, randomized controlled trial designed to evaluate the efficacy and safety of partial cardiac denervation for the prevention of POAF in patients undergoing isolated coronary artery bypass grafting (CABG). A total of approximately 1,470 participants will be randomly assigned in a 1:1 ratio to undergo CABG with partial cardiac denervation or CABG alone. Partial cardiac denervation consists of transection of the ligament of Marshall and resection of the Waterston fat pad.

The trial will evaluate the incidence of POAF within the first 6 postoperative days and the occurrence of long-term adverse clinical events. Participants will undergo scheduled rhythm monitoring and clinical follow-up, and all participants will be followed until the last enrolled participant completes 3 years of follow-up after surgery.

Aperçu de l'étude

Statut

Pas encore de recrutement

Les conditions

Intervention / Traitement

Description détaillée

Postoperative atrial fibrillation (POAF) is a common complication after coronary artery bypass grafting (CABG) and is associated with increased risks of stroke, myocardial infarction, prolonged hospitalization, and other adverse outcomes. Autonomic imbalance and excessive activation of the intrinsic cardiac autonomic nervous system are considered important contributors to the development of POAF. Previous studies of pharmacological or biological autonomic modulation have shown variable efficacy, and their effects may be transient.

A previous single-center randomized trial conducted by the investigators showed that partial cardiac denervation, consisting of transection of the ligament of Marshall and resection of the Waterston fat pad, reduced the incidence of POAF after CABG without increasing perioperative complications. The CALM trial is designed to evaluate whether these findings can be reproduced across multiple centers and to investigate the potential long-term clinical and autonomic effects of this intervention.

This is a prospective, multicenter, randomized controlled trial involving approximately 1,470 patients undergoing isolated CABG with or without cardiopulmonary bypass. Participants will be randomly assigned in a 1:1 ratio to partial cardiac denervation in addition to standard CABG or to standard CABG alone. Centralized randomization will be stratified by participating center and baseline CHA2DS2-VASc score. Treatment allocation will be disclosed to the operating surgeon only after induction of anesthesia. Participants, outcome assessors, electrocardiographic reviewers, clinical event adjudicators, and statisticians will remain blinded to treatment allocation.

In the intervention group, the ligament of Marshall, located between the left atrial appendage and the left pulmonary veins, will be transected using electrocautery. The Waterston fat pad, located in the interatrial groove between the right atrium and the right pulmonary veins, will then be completely resected down to the epicardial surface. No additional denervation procedure will be performed in the control group. Other aspects of CABG and perioperative care will follow routine clinical practice at each participating center.

Continuous electrocardiographic monitoring will be performed during the early postoperative period, and scheduled ambulatory electrocardiographic monitoring will be conducted during follow-up. Electrocardiographic recordings will be centrally reviewed by an independent ECG Core Laboratory. Suspected clinical endpoint events will be adjudicated by an independent Clinical Event Adjudication Committee blinded to treatment allocation. Participants will undergo scheduled clinical follow-up for assessment of arrhythmias, cardiac autonomic function, and long-term clinical outcomes. All participants will be followed until the last enrolled participant has completed 3 years of follow-up after surgery.

Type d'étude

Interventionnel

Inscription (Estimé)

1470

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: Ziang Yang, M.D.
  • Numéro de téléphone: 86+19801109287
  • E-mail: yzang47@163.com

Lieux d'étude

  • Chine
    • Beijing Municipality
      • Beijing, Beijing Municipality, Chine, 100000
        • Fuwai Hospital, PUMC & CAMS
        • Contact:
        • Chercheur principal:
          • Wei Feng, M.D.
        • Chercheur principal:
          • Zhan Hu, M.D.
    • Guangdong
      • Guangzhou, Guangdong, Chine, 510080
        • Guangdong Provincial People's Hospital
        • Contact:
          • Qiang Gao, M.D.
    • Henan
      • Zhenzhou, Henan, Chine, 451464
        • Fuwai Central China Cardiovascular Hospital
        • Contact:
          • Junlong Hu, M.D.
    • Hunan
      • Changsha, Hunan, Chine, 410011
        • The Second Xiangya Hospital of Central South University
        • Contact:
          • Xiaobo Liao, M.D.
    • Jiangsu
      • Nanjing, Jiangsu, Chine, 210006
        • Nanjing First Hospital, Nanjing Medical University
        • Contact:
          • Fei Xiang, M.D.

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

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

Inclusion Criteria:

  • Adults aged 18 years or older.
  • Scheduled to undergo isolated coronary artery bypass grafting, either with or without cardiopulmonary bypass.
  • Able and willing to provide written informed consent.
  • No atrial fibrillation detected on preoperative 24-hour electrocardiographic monitoring.

Exclusion Criteria:

  • Previous cardiac surgery.
  • Emergency surgery.
  • Preoperative critical condition.
  • Left ventricular ejection fraction of 30% or lower.
  • Left atrial diameter greater than 50 mm.
  • Prior history of atrial fibrillation.
  • Use of antiarrhythmic medications other than beta-blockers within 2 weeks before surgery.
  • Planned concomitant cardiac procedures, including but not limited to congenital heart disease surgery or left ventricular reconstruction.

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: Tripler

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Aucune intervention: Control group

CABG alone
Expérimental: Intervention group

Partial cardiac denervation + CABG. Partial cardiac denervation consists of transection of the ligament of Marshall and resection of the Waterston fat pad.
Procédure: Partial Cardiac Denervation

The intervention has been described in previous studies. Briefly, intraoperative partial cardiac denervation is achieved by transection of the left LOM and resection of the right Waterston fat pad using electrocautery.

During the procedure, the pulmonary trunk is first gently retracted to the right to expose the LOM located between the left atrial appendage and the left pulmonary veins. The LOM is then transected using electrocautery. Subsequently, the right atrium is retracted to the left to expose the Waterston fat pad located in the interatrial groove. The Waterston fat pad is completely excised with electrocautery down to the epicardial surface.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Incidence of Postoperative Atrial Fibrillation Within 6 Postoperative Days
Délai: From admission to the intensive care unit after surgery until postoperative day 6.

The proportion of participants with documented new-onset postoperative atrial fibrillation (POAF). POAF is defined as an episode of atrial fibrillation characterized by irregularly irregular RR intervals and the absence of discernible P waves, lasting more than 30 seconds. Continuous electrocardiographic recordings will be centrally reviewed by the blinded ECG Core Laboratory.
From admission to the intensive care unit after surgery until postoperative day 6.
Time to First Occurrence of the Composite Clinical Outcome
Délai: From surgery until 3 years after enrollment of the last participant, with a minimum follow-up of 3 years for each participant.

Time from surgery to the first occurrence of any component of the composite outcome, including all-cause death, stroke, systemic embolism, myocardial infarction, readmission for cardiac reasons, or post-discharge atrial fibrillation. Suspected clinical events will be adjudicated by an independent Clinical Event Adjudication Committee blinded to treatment allocation. Post-discharge atrial fibrillation events will be reviewed by the blinded ECG Core Laboratory.
From surgery until 3 years after enrollment of the last participant, with a minimum follow-up of 3 years for each participant.

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Postoperative Length of Hospital Stay
Délai: From the date of surgery through discharge from the index hospitalization (an estimated period of up to 30 days)

The number of days from the date of surgery to hospital discharge.
From the date of surgery through discharge from the index hospitalization (an estimated period of up to 30 days)
Total Hospitalization Costs
Délai: From the date of surgery through discharge from the index hospitalization (an estimated period of up to 30 days)

Total medical costs incurred during the index hospitalization.
From the date of surgery through discharge from the index hospitalization (an estimated period of up to 30 days)
Incidence of Perioperative All-Cause Mortality
Délai: From the date of surgery through discharge from the index hospitalization (an estimated period of up to 30 days)

The proportion of participants who die from any cause during the perioperative hospitalization.
From the date of surgery through discharge from the index hospitalization (an estimated period of up to 30 days)
Incidence of Perioperative New-Onset Stroke
Délai: From the date of surgery through discharge from the index hospitalization (an estimated period of up to 30 days)

The proportion of participants who experience a new-onset stroke during the perioperative hospitalization, as adjudicated by the blinded Clinical Event Adjudication Committee according to predefined endpoint criteria.
From the date of surgery through discharge from the index hospitalization (an estimated period of up to 30 days)
Incidence of Perioperative Myocardial Infarction
Délai: From the date of surgery through discharge from the index hospitalization (an estimated period of up to 30 days)

The proportion of participants who experience myocardial infarction during the perioperative hospitalization, as adjudicated by the blinded Clinical Event Adjudication Committee according to predefined endpoint criteria.
From the date of surgery through discharge from the index hospitalization (an estimated period of up to 30 days)
Postoperative Atrial Fibrillation Burden Within 6 Postoperative Days
Délai: From admission to the intensive care unit after surgery until postoperative day 6.

The proportion of analyzable electrocardiographic monitoring time spent in atrial fibrillation during the early postoperative monitoring period, as determined by the blinded ECG Core Laboratory.
From admission to the intensive care unit after surgery until postoperative day 6.
Number of Postoperative Atrial Fibrillation Episodes Within 6 Postoperative Days
Délai: From admission to the intensive care unit after surgery until postoperative day 6.

The total number of documented postoperative atrial fibrillation episodes per participant during the early postoperative monitoring period, as determined by the blinded ECG Core Laboratory.
From admission to the intensive care unit after surgery until postoperative day 6.
Duration of Postoperative Atrial Fibrillation Within 6 Postoperative Days
Délai: From admission to the intensive care unit after surgery until postoperative day 6.

The cumulative duration of documented postoperative atrial fibrillation episodes during the early postoperative monitoring period, as determined by the blinded ECG Core Laboratory.
From admission to the intensive care unit after surgery until postoperative day 6.
Incidence of Post-Discharge Atrial Fibrillation
Délai: From discharge until the end of study follow-up, with a minimum follow-up of 3 years for each participant.

The proportion of participants with atrial fibrillation documented after discharge by scheduled 3-day ambulatory electrocardiographic monitoring or by clinically obtained electrocardiographic recordings. All suspected events will be reviewed by the blinded ECG Core Laboratory.
From discharge until the end of study follow-up, with a minimum follow-up of 3 years for each participant.
Post-Discharge Atrial Fibrillation Burden
Délai: At 3 months, 1 year, and annually thereafter until study completion, with a minimum follow-up of 3 years for each participant.

The proportion of analyzable ambulatory electrocardiographic monitoring time spent in atrial fibrillation during each scheduled 3-day monitoring period, as determined by the blinded ECG Core Laboratory.
At 3 months, 1 year, and annually thereafter until study completion, with a minimum follow-up of 3 years for each participant.
Incidence of Non-Atrial Fibrillation Arrhythmias
Délai: From surgery until the end of study follow-up, with a minimum follow-up of 3 years for each participant.

The proportion of participants with predefined non-atrial fibrillation arrhythmias, including third-degree atrioventricular block, frequent premature atrial contractions, and frequent premature ventricular contractions, as determined by the blinded ECG Core Laboratory.
From surgery until the end of study follow-up, with a minimum follow-up of 3 years for each participant.
Heart Rate Variability Parameters
Délai: During the first 6 postoperative days and at 3 months, 1 year, and annually thereafter until study completion, with a minimum follow-up of 3 years for each participant.

Cardiac autonomic function will be assessed using time-domain and frequency-domain heart rate variability parameters obtained from electrocardiographic monitoring. Measurements will be centrally analyzed by the blinded ECG Core Laboratory.
During the first 6 postoperative days and at 3 months, 1 year, and annually thereafter until study completion, with a minimum follow-up of 3 years for each participant.
Health-Related Quality of Life Assessed Using the EuroQol 5-Dimension 5-Level Questionnaire
Délai: At 3 months, 1 year, and annually thereafter until study completion, with a minimum follow-up of 3 years for each participant.

Health-related quality of life will be assessed using the EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L). An EQ-5D-5L health utility index will be calculated using the Chinese population value set. The index ranges from -0.391 to 1.000, with higher scores indicating better health status. A score of 1.000 represents full health, 0 represents a health state equivalent to death, and negative values represent health states considered worse than death. Scores will be compared between the two treatment groups at scheduled follow-up assessments.
At 3 months, 1 year, and annually thereafter until study completion, with a minimum follow-up of 3 years for each participant.
Atrial Fibrillation-Related Quality of Life Assessed Using the Atrial Fibrillation Effect on QualiTy-of-Life Questionnaire
Délai: At 3 months, 1 year, and annually thereafter until study completion, with a minimum follow-up of 3 years for each participant.

Atrial fibrillation-related quality of life will be assessed using the Atrial Fibrillation Effect on QualiTy-of-Life Questionnaire (AFEQT). The AFEQT Overall Summary Score ranges from 0 to 100, with higher scores indicating better atrial fibrillation-related health status and quality of life and lower scores indicating greater impairment. Scores will be compared between the two treatment groups at scheduled follow-up assessments.
At 3 months, 1 year, and annually thereafter until study completion, with a minimum follow-up of 3 years for each participant.
Incidence of Reoperation for Bleeding
Délai: From the date of surgery through discharge from the index hospitalization (an estimated period of up to 30 days).

The proportion of participants who require surgical re-exploration because of postoperative bleeding.
From the date of surgery through discharge from the index hospitalization (an estimated period of up to 30 days).
Incidence of Postoperative Blood Transfusion
Délai: From the date of surgery through discharge from the index hospitalization (an estimated period of up to 30 days).

The proportion of participants who receive a blood transfusion after surgery during the index hospitalization.
From the date of surgery through discharge from the index hospitalization (an estimated period of up to 30 days).
Incidence of Delayed Moderate or Greater Pericardial Effusion
Délai: From discharge from the index hospitalization through 30 days after discharge.

The proportion of participants who develop new-onset moderate or greater pericardial effusion within 30 days after discharge from the index hospitalization, as documented by echocardiography.
From discharge from the index hospitalization through 30 days after discharge.

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

China National Center for Cardiovascular Diseases

Collaborateurs

Chinese Academy of Medical Sciences

Les enquêteurs

  • Chercheur principal: Mario Gaudino, M.D., Weill Medical College of Cornell University

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 décembre 2026

Achèvement primaire (Estimé)

31 décembre 2030

Achèvement de l'étude (Estimé)

31 décembre 2030

Dates d'inscription aux études

Première soumission

23 octobre 2026

Première soumission répondant aux critères de contrôle qualité

31 octobre 2026

Première publication (Réel)

5 novembre 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

5 novembre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

31 octobre 2026

Dernière vérification

1 octobre 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • NCRC2026001
  • 2026-12M-SXZX1-05 (Autre subvention/numéro de financement: Chinese Academy of Medical Sciences)

Plan pour les données individuelles des participants (IPD)

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OUI

Type d'informations de prise en charge du partage d'IPD

  • PROTOCOLE D'ÉTUDE
  • SÈVE
  • RSE

Informations sur les médicaments et les dispositifs, documents d'étude

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Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

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