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.
調査の概要
状態
詳細な説明
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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Young Keun On, MD, PhD
- 電話番号：+82-2-3410-2578
- メール：yk.on@samsung.com
研究場所
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Seoul
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Seoul、Seoul、韓国、06351
- 募集
- Samsung Medical Center
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コンタクト：
- Young Keun On, MD, PhD
- 電話番号：+82-2-3410-2578
- メール：yk.on@samsung.com
-
コンタクト：
-
-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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.
|
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.
|
|
アクティブコンパレータ：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.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Recurrence of atrial tachyarrhythmia
時間枠：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
|
二次結果の測定
結果測定 |
時間枠 |
|---|---|
|
Recurrence of atrial fibrillation
時間枠：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
時間枠：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
時間枠：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
|
|
All-cause death
時間枠：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
時間枠：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
時間枠：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
|
|
Hospitalization for heart failure
時間枠：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
時間枠：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
|
協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- SMC 2023-06-103
- KCT0009360 (その他の識別子：Korea National Institute of Health)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
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