Thoracoscopic Versus Catheter Ablation in Persistent Atrial Fibrillation With Enlarged Left Atrium
Endocardial Catheter Ablation Versus Thoracoscopic Ablation in De Novo Persistent Atrial Fibrillation Patients With Enlarged Left Atrium: A Randomized Controlled Trial
This is a prospective, single-center, open-label, randomized controlled trial comparing thoracoscopic surgical ablation with percutaneous endocardial catheter ablation as the first rhythm-control procedure in patients with persistent atrial fibrillation and an enlarged left atrium (LA diameter ≥50 mm or LA volume index ≥45 mL/m²).
A total of 194 patients who have never undergone an ablation procedure for atrial fibrillation will be randomly assigned 1:1 to thoracoscopic ablation or percutaneous catheter ablation, stratified by duration of atrial fibrillation. The primary endpoint is recurrence of atrial tachyarrhythmia (atrial fibrillation, atrial flutter, or atrial tachycardia) after a 3-month blanking period. The investigators hypothesize that thoracoscopic ablation will significantly reduce recurrence compared with catheter ablation in this population.
A secondary hypothesis is that 14-day patch monitoring detects recurrent atrial tachyarrhythmia more sensitively than conventional 24-hour Holter monitoring.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Pulmonary vein isolation is an established rhythm-control therapy for symptomatic atrial fibrillation refractory to antiarrhythmic drugs. Its efficacy is lower in persistent than in paroxysmal atrial fibrillation, and additional substrate modification of the left atrium is frequently required.
Percutaneous catheter ablation (radiofrequency, cryoballoon or PFA) and thoracoscopic surgical ablation are both used in current practice. Thoracoscopic ablation additionally allows epicardial pulmonary vein isolation, ganglionated plexi ablation, dissection of the ligament of Marshall, and left atrial appendage exclusion, at the cost of a longer hospital stay and a higher incidence of post-procedural pericarditis. Recent trials have shown broadly comparable efficacy and safety between the two approaches, so both are used interchangeably in practice.
In a retrospective analysis of the institutional ablation registry at the study site, overall outcomes of the two strategies were comparable, but among patients with an enlarged left atrium thoracoscopic ablation was associated with significantly lower recurrence of atrial tachyarrhythmia. Because that finding came from a subgroup of a retrospective cohort, it could not support a firm conclusion.
This trial therefore prospectively tests, in patients with persistent atrial fibrillation and an enlarged left atrium undergoing a first rhythm-control procedure, whether thoracoscopic ablation is superior to percutaneous catheter ablation.
Post-procedural management is identical in both arms: a 3-month blanking period, discontinuation of antiarrhythmic drugs at 3 months (up to 6 months) if sinus rhythm is maintained, and anticoagulation for at least 3 months with subsequent decisions based on recurrence, prior stroke, and CHA2DS2-VASc score. Follow-up visits occur at 3, 6, and 12 months and every 6 months thereafter until 1 year after the last patient is enrolled. Rhythm monitoring uses 12-lead ECG, 24-hour Holter (3, 6, 12 months), and 14-day patch monitoring; echocardiography and NT-proBNP are obtained at baseline, 12 months, and annually thereafter.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Young Keun On, MD, PhD
- Numéro de téléphone: +82-2-3410-2578
- E-mail: yk.on@samsung.com
Lieux d'étude
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Seoul
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Seoul, Seoul, Corée du Sud, 06351
- Recrutement
- Samsung Medical Center
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Contact:
- Young Keun On, MD, PhD
- Numéro de téléphone: +82-2-3410-2578
- E-mail: yk.on@samsung.com
-
Contact:
- E-mail: abcd186a@naver.com
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
La description
Inclusion Criteria:
- Age 19 years or older
- Persistent atrial fibrillation refractory to antiarrhythmic drug therapy, or in whom antiarrhythmic drug therapy cannot be maintained
- European Heart Rhythm Association (EHRA) symptom score ≥ 2
- Considered suitable for rhythm-control therapy by either percutaneous catheter ablation or thoracoscopic ablation, at the investigator's medical discretion
- Enlarged left atrium, defined as left atrial diameter ≥ 50 mm or left atrial volume index ≥ 45 mL/m²
Exclusion Criteria:
- Previous percutaneous catheter ablation or thoracoscopic ablation for atrial fibrillation
- Previous thoracic or cardiac surgery
- Absolute contraindication to anticoagulation therapy
- Life expectancy less than 1 year due to non-cardiac disease, or anticipated poor adherence to treatment, at the investigator's medical discretion
- Refusal to participate in the study
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Thoracoscopic ablation
Thoracoscopic surgical ablation is performed according to the standard technique.
Pulmonary vein isolation and left atrial appendage exclusion are mandatory.
Additional lesions are at the operator's discretion.
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Thoracoscopic surgical ablation is performed according to the standard technique.
Pulmonary vein isolation and left atrial appendage exclusion are mandatory.
Additional lesions are at the operator's discretion.
|
|
Comparateur actif: Percutaneous catheter ablation
Percutaneous endocardial catheter ablation is performed using radiofrequency, cryoballoon, or pulsed field energy.
Pulmonary vein isolation is mandatory.
Additional lesions are at the operator's discretion.
|
Percutaneous endocardial catheter ablation is performed using radiofrequency, cryoballoon, or pulsed field energy.
Pulmonary vein isolation is mandatory.
Additional lesions are at the operator's discretion.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Recurrence of atrial tachyarrhythmia
Délai: From 3 months after the index procedure until 1 year after enrollment of the last patient
|
Recurrence of atrial fibrillation, atrial flutter, or atrial tachycardia, defined as an episode documented on 12-lead ECG or sustained for at least 30 seconds on continuous monitoring (14-day patch monitor or 24-hour Holter).
Recurrences during the 3-month blanking period are not counted as events.
|
From 3 months after the index procedure until 1 year after enrollment of the last patient
|
Mesures de résultats secondaires
Mesure des résultats |
Délai |
|---|---|
|
Recurrence of atrial fibrillation
Délai: From 3 months after the index procedure until 1 year after enrollment of the last patient
|
From 3 months after the index procedure until 1 year after enrollment of the last patient
|
|
Recurrence of atrial flutter
Délai: From 3 months after the index procedure until 1 year after enrollment of the last patient
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From 3 months after the index procedure until 1 year after enrollment of the last patient
|
|
Recurrence of atrial tachycardia
Délai: From 3 months after the index procedure until 1 year after enrollment of the last patient
|
From 3 months after the index procedure until 1 year after enrollment of the last patient
|
|
All-cause death
Délai: From 3 months after the index procedure until 1 year after enrollment of the last patient
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From 3 months after the index procedure until 1 year after enrollment of the last patient
|
|
Cardiac death
Délai: From 3 months after the index procedure until 1 year after enrollment of the last patient
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From 3 months after the index procedure until 1 year after enrollment of the last patient
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Stroke
Délai: From 3 months after the index procedure until 1 year after enrollment of the last patient
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From 3 months after the index procedure until 1 year after enrollment of the last patient
|
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Hospitalization for heart failure
Délai: From 3 months after the index procedure until 1 year after enrollment of the last patient
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From 3 months after the index procedure until 1 year after enrollment of the last patient
|
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Procedure-related complications
Délai: From 3 months after the index procedure until 1 year after enrollment of the last patient
|
From 3 months after the index procedure until 1 year after enrollment of the last patient
|
Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
- Maladies cardiovasculaires
- Processus pathologiques
- Maladies cardiaques
- Arythmies cardiaques
- Conditions pathologiques, signes et symptômes
- Fibrillation auriculaire
- Thérapeutique
- Procédures chirurgicales, opératoires
- Techniques d'ablation
- Ablation radiofréquence
- Thérapie par radiofréquence
- Ablation du cathéter
Autres numéros d'identification d'étude
- SMC 2023-06-103
- KCT0009360 (Autre identifiant: Korea National Institute of Health)
Plan pour les données individuelles des participants (IPD)
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Informations sur les médicaments et les dispositifs, documents d'étude
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