A Comparative Study of Percutaneous Pulsed Field Ablation Guided by Ultrasound Alone Versus Fluoroscopy in Patients With Atrial Fibrillation
2026年8月11日 更新者：China National Center for Cardiovascular Diseases
This prospective, randomized, multicenter, open-label, non-inferiority interventional study aims to compare the therapeutic efficacy of percutaneous pulsed field ablation (PFA) guided by ultrasound alone versus fluoroscopy in patients with paroxysmal atrial fibrillation (AF).
The success rate of complete electrical isolation of pulmonary veins during the procedure was compared to verify that ultrasound-only guidance is non-inferior to fluoroscopic guidance.
調査の概要
状態
まだ募集していません
研究の種類
介入
入学 (推定)
276
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：MIN TANG, Doctor
- 電話番号：86+ 13810665178
- メール：doctordangmin@sina.com
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
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
いいえ
説明
Inclusion Criteria:
- Adult patients aged 18 to 75 years (including 18 years and 75 years of age).
- Patients diagnosed with paroxysmal atrial fibrillation via 12-lead electrocardiography or ambulatory electrocardiography and scheduled to undergo pulsed field ablation.
- Subjects are able to understand the purpose of the study, voluntarily participate in the study and sign the informed consent, and are willing to complete the follow-up according to the requirements of the program.
Exclusion Criteria:
- Atrial fibrillation secondary to electrolyte imbalance, thyroid disorders, or reversible non-cardiac causes;
- Previous history of catheter ablation or cardiac surgery for atrial fibrillation;
- Prior surgical history including patent foramen ovale closure, atrial septal defect closure or repair;
- Implantation of left atrial appendage occluder, mechanical mitral valve prosthesis, or valvuloplasty ring containing metallic materials;
- Concomitant other tachyarrhythmias requiring catheter ablation (e.g., atrioventricular reentrant tachycardia, atrioventricular nodal reentrant tachycardia, atrial tachycardia, atrial flutter, Wolff-Parkinson-White syndrome, etc.);
- Persistent atrial fibrillation;
- Left atrial anteroposterior diameter (LAD) > 55 mm on transthoracic echocardiography;
- Women who are pregnant, breastfeeding, or of childbearing age with plans to become pregnant during the clinical trial;
- Current participation in another pharmaceutical or medical device clinical study.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
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：Percutaneous pulsed field ablation performed under ultrasound-only guidance.
Percutaneous pulsed field ablation is performed under ultrasound-only guidance in patients with paroxysmal atrial fibrillation.
|
Percutaneous pulsed field ablation is performed under ultrasound-only guidance in patients with paroxysmal atrial fibrillation.
|
|
アクティブコンパレータ：Pulsed field ablation performed under fluoroscopic guidance
Patients with paroxysmal atrial fibrillation underwent percutaneous pulsed field ablation under fluoroscopic guidance.
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Patients with paroxysmal atrial fibrillation underwent percutaneous pulsed field ablation under fluoroscopic guidance.
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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 |
|---|---|---|
|
Success rate of complete electrical isolation of pulmonary veins during the procedure
時間枠：Immediately post-procedure
|
The proportion of all pulmonary veins maintaining bidirectional block across ablation lines at 20 minutes after ablation completion.
|
Immediately post-procedure
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
The incidence of complications within 30 days after the procedure
時間枠：Within 30 days post-procedure
|
Observe the proportion of complications occurring within 30 days after the procedure.
Such complications include pericardial effusion or cardiac tamponade requiring drainage, phrenic nerve palsy lasting more than 24 hours, severe vascular complications requiring intervention, stroke/transient ischemic attack, atrioesophageal fistula, and death.
|
Within 30 days post-procedure
|
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Success rate of atrial fibrillation ablation at 12 months post-procedure.
時間枠：12 months post-procedure
|
Defined as the absence of AF, atrial flutter (AFL), or atrial tachycardia (AT) episodes ≥30 seconds on dynamic electrocardiogram (ECG) monitoring after the blanking period (90 days post-catheter ablation)
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12 months post-procedure
|
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The proportion of patients admitted to hospital or emergency departments due to atrial fibrillation recurrence within 12 months after the procedure.
時間枠：12 months post-procedure
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The proportion of patients admitted to hospital or emergency departments due to atrial fibrillation recurrence within 12 months after the procedure.
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12 months post-procedure
|
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The proportion of patients who received electrical cardioversion due to atrial fibrillation recurrence within 12 months after the procedure
時間枠：12 months post-procedure
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The proportion of patients who received electrical cardioversion due to atrial fibrillation recurrence within 12 months after the procedure.
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12 months post-procedure
|
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The proportion of patients undergoing repeat ablation surgery owing to atrial fibrillation within 12 months after the procedure
時間枠：12 months post-procedure
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The proportion of patients undergoing repeat ablation surgery owing to atrial fibrillation within 12 months after the procedure
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12 months post-procedure
|
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The proportion of patients who resumed antiarrhythmic drug therapy during follow-up after the blanking period
時間枠：From the end of the blanking period (within 90 days after catheter ablation) to 12 months post-procedure
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The proportion of patients who resumed antiarrhythmic drug therapy during follow-up after the blanking period
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From the end of the blanking period (within 90 days after catheter ablation) to 12 months post-procedure
|
|
Improvement in the total EQ-5D quality-of-life questionnaire score at 12 months post-procedure compared with baseline
時間枠：12 months post-procedure
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The degree of improvement in total EQ-5D scores at 12 months after ablation relative to baseline levels
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12 months post-procedure
|
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Statistical analysis was performed to evaluate differences in fluoroscopic exposure dose between the two groups.
時間枠：Immediately post-procedure
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Statistical analysis was performed to evaluate differences in fluoroscopic exposure dose between the two groups.
|
Immediately post-procedure
|
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Compare the length of hospital stay and postprocedural ICU/CCU stay duration between the two groups.
時間枠：through study completion, an average of 1 year
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After hospital discharge, the length of hospital stay for this admission and the duration of postoperative observation in CCU/ICU were compared between the two groups of patients.
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through study completion, an average of 1 year
|
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Compare the procedural time and DSA fluoroscopy time between the two groups.
時間枠：Immediately post-procedure
|
Statistical analyses were performed to compare procedural duration and DSA fluoroscopy duration across the two groups.
|
Immediately post-procedure
|
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Compare the differences in costs between the two groups, including medical equipment costs, personnel costs, and patient hospitalization expenses.
時間枠：through study completion, an average of 1 year
|
Total hospitalization costs incurred during this admission were compared between the two groups after hospital discharge.
|
through study completion, an average of 1 year
|
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研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年8月15日
一次修了 (推定)
2029年2月28日
研究の完了 (推定)
2029年2月28日
試験登録日
最初に提出
2026年7月29日
QC基準を満たした最初の提出物
2026年8月11日
最初の投稿 (実際)
2026年8月13日
学習記録の更新
投稿された最後の更新 (実際)
2026年8月13日
QC基準を満たした最後の更新が送信されました
2026年8月11日
最終確認日
2026年7月1日
詳しくは
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