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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Young Keun On, MD, PhD
- Telefonnummer: +82-2-3410-2578
- E-mail: yk.on@samsung.com
Studiesteder
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Seoul
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Seoul, Seoul, Sydkorea, 06351
- Rekruttering
- Samsung Medical Center
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Kontakt:
- Young Keun On, MD, PhD
- Telefonnummer: +82-2-3410-2578
- E-mail: yk.on@samsung.com
-
Kontakt:
- E-mail: abcd186a@naver.com
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-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 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.
|
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Aktiv komparator: 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.
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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.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Recurrence of atrial tachyarrhythmia
Tidsramme: From 3 months after the index procedure until 1 year after enrollment of the last patient
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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
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Recurrence of atrial fibrillation
Tidsramme: 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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Recurrence of atrial flutter
Tidsramme: 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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Recurrence of atrial tachycardia
Tidsramme: 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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All-cause death
Tidsramme: 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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Cardiac death
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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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Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- SMC 2023-06-103
- KCT0009360 (Anden identifikator: Korea National Institute of Health)
Plan for individuelle deltagerdata (IPD)
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