Empirical Anatomy-Based Ablation vs Emphasize Map-Guided Substrate Ablation in Persistent Atrial Fibrillation : (COMPASS-AF) (COMPASS-AF)
2026年7月21日 更新者：Ju Youn Kim、Samsung Medical Center
This study is aimed to compare the clinical efficacy of two different catheter ablation strategies in patients with persistent atrial fibrillation.
Participants will be randomized 1:1 into either the Anatomy-based group or the Emphasize map-guided group
- Anatomy-based group : Pulmonary vein isolation (PVI) using pulsed-field ablation (PFA) with a single-shot multielectrode catheter.
- Emphasize map-guided group : PVI using radiofrequency (RF) ablation followed by additional EnSite X-guided pathologic substrate modification.
Participants will be followed for 1 year to compare the incidence of any atrial tachyarrhythmia and other clinical parameters between the two groups.
調査の概要
状態
状態
募集
条件
条件
介入・治療
介入・治療
詳細な説明
Pulsed-field ablation (PFA) is increasingly being adopted in clinical practice due to its advantages in shortening procedure times and reducing the incidence of complications. While the majority of PFA-related research has focused on PVI-centric strategies, recent studies have reported that posterior wall isolation (PWI) using PFA can also be performed safely. However, sufficient clinical evidence regarding the efficacy of additional ablation strategies beyond PVI in patients with persistent atrial fibrillation (AF) has yet to be established.
The Emphasize mapping system, a software feature within the EnSite X platform, is designed to simultaneously visualize Voltage maps, Peak frequency, and CFAE-related information. Unlike the individual analysis of each parameter, this integrated approach allows for a more precise identification of electrophysiologically significant pathologic substrates by evaluating the complex characteristics of electrical signals holistically. Currently, however, Emphasize-guided ablation is technically limited to the use of radiofrequency (RF) energy.
Persistent AF is characterized by complex and heterogeneous mechanisms, meaning a single, uniform ablation strategy may not yield consistent clinical outcomes across all patients. Consequently, it is hypothesized that an individualized substrate ablation strategy guided by functional mapping may be more effective than a conventional, empirical anatomy-based approach.
Therefore, this study aims to compare the clinical efficacy and safety of an empirical anatomy-based ablation strategy using PFA versus an individualized Emphasize map-guided substrate ablation strategy in patients with persistent AF.
研究の種類
研究の種類
介入
入学 (推定)
入学
360
段階
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
研究連絡先
- 名前：Ju Youn Kim, Ph.D
- 電話番号：82+ 2-3410-3419
- メール：kzzoo921@gmail.com
研究場所
-
-
Seoul
-
Seoul、Seoul、韓国、06351
- 募集
- Samsung Medical Center
-
コンタクト：
- Ju Youn Kim, Ph.D
- 電話番号：82+ 2-3410-3419
- メール：kzzoo921@gmail.com
-
Seoul、Seoul、韓国、06351
- まだ募集していません
- Samsung Medical Center
-
コンタクト：
- Ju Youn Kim, Ph.D
- 電話番号：82+ 2-3410-3419
- メール：kzzoo921@gmail.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
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:
- Adults aged 19 years or older who have voluntarily provided written informed consent to participate in the study
- Patients diagnosed with persistent atrial fibrillation (AF) who are scheduled to undergo catheter ablation for AF.
Exclusion Criteria:
- History of prior catheter ablation or MAZE surgery for atrial fibrillation.
- Left atrial (LA) diameter exceeding 60 mm.
- Patients with end-stage renal disease (ESRD).
- History of prior open-heart surgery.
- Women who are pregnant, lactating, or of childbearing potential.
- Heart failure corresponding to New York Heart Association (NYHA) functional class IV.
- Acute coronary syndrome (ACS) experienced within the past 3 months.
- Patients with terminal illness and a life expectancy of less than one year.
- Any other condition that the investigator deems inappropriate for participation in the 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）
アーム数
2
武器と介入
参加者グループ / アーム参加者グループ / アーム |
介入・治療介入・治療 |
|---|---|
|
アクティブコンパレータ：Anatomy-based group
|
In the empirical anatomy-based ablation strategy group, pulmonary vein isolation (PVI) will be performed using pulsed-field ablation (PFA) with a single-shot multielectrode catheter.
For each pulmonary vein, approximately 4-10 pulse applications will be delivered depending on the catheter position, with each application consisting of several seconds of pulse delivery.
The catheter will be positioned around the PV ostia, and electrical isolation will be achieved by utilizing various catheter configurations as necessary.
The energy settings and application methods for PFA in this study will follow the manufacturer's recommended protocols and established methods from prior clinical studies.
Additionally, the creation of supplementary lesion sets is permitted at the operator's discretion.
|
|
実験的：Emphasize map-guided group
|
In the Emphasize map-guided substrate ablation group, ablation will be performed using a contact force-sensing irrigated radiofrequency (RF) catheter.
Following pulmonary vein isolation (PVI), an Emphasize map will be acquired during atrial fibrillation (AF) using the EnSite X mapping system.
Based on this map, electrophysiologically significant pathologic substrates will be evaluated, and additional substrate ablation will be performed.
Subsequently, electrical cardioversion will be conducted to restore sinus rhythm.
If sinus rhythm is not maintained or if AF is re-induced, an additional Emphasize map may be acquired in the right atrium (RA), and RA substrate ablation can be performed if necessary.
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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
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 to 12 months after the index procedure
|
Any documented atrial tachyarrhythmias excluding the initial 3-month blanking period. Documented atrial tachyarrhythmias (atrial fibrillation, atrial flutter, atrial tachycardia) were defined as follows:
|
From 3 months to 12 months after the index procedure
|
二次結果の測定
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Atrial fibrillation burden
時間枠：From 3 months to 12 months after the index procedure
|
The proportion of time spent in atrial fibrillation or atrial flutter during rhythm monitoring .The burden will be assessed as percent(%) using Holter monitoring.
|
From 3 months to 12 months after the index procedure
|
|
Repeat ablation
時間枠：From index procedure to 12 months
|
Any additional catheter ablation procedure performed after the index procedure for documented recurrent atrial tachyarrhythmia during the follow-up period.
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From index procedure to 12 months
|
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Use of antiarrhythmic drug therapy
時間枠：From 3 months to 12 months after the index procedure
|
Percentage of patients prescribed any Class I or Class III antiarrhythmic Temporary use during the blanking period (first 3 months) will not be counted.
|
From 3 months to 12 months after the index procedure
|
|
Atrial Fibrillation Effect on Quality-of-life (AFEQT) questionnaire score
時間枠：From index procedure to 12 months
|
The AFEQT is outcome instrument designed to measure the impact of AF on a patient's health-related quality of life.
Scores range from 0 to 100, with higher scores indicating a better health-related quality of life
|
From index procedure to 12 months
|
|
Stroke
時間枠：From index procedure to 12 months
|
Proportion of participants experiencing a new focal or global neurological deficit lasting ≥24 hours with imaging evidence of ischemic or hemorrhagic stroke.
Transient ischemic attack will not be included.
|
From index procedure to 12 months
|
|
Cardiovascular hospitalization
時間枠：From index procedure to 12 months
|
Proportion of participants experiencing hospitalization primarily due to a cardiovascular cause, including:
|
From index procedure to 12 months
|
|
Bleeding event
時間枠：From index procedure to 12 months
|
Proportion of participants experiencing bleeding events. Bleeding event will be classified according to the International Society on Thrombosis and Haemostasis(ISTH) criteria:
|
From index procedure to 12 months
|
|
All-cause mortality
時間枠：From index procedure to 12 months
|
Death due to any cause occurring during the follow-up period.
|
From index procedure to 12 months
|
|
Procedure-related complications
時間枠：From index procedure to 30days
|
Proportion of participants experiencing any complication occurring during or within 30 days after the index procedure, including:
|
From index procedure to 30days
|
|
Procedure time
時間枠：at the index procedure
|
Total procedure time measured in minutes from vascular access puncture to removal of all catheters at the end of the procedure.
|
at the index procedure
|
|
Radiation time
時間枠：at the index procedure
|
Total fluoroscopy exposure time measured in minutes.
|
at the index procedure
|
|
Left atrial reservoir strain
時間枠：From index procedure to 12 months
|
Measured as percentage by echocardiography
|
From index procedure to 12 months
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
協力者
協力者
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
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- Honarbakhsh S, Horrach CV, Lambiase PD, Roney C, Hunter RJ. The effect of fixed and functional remodelling on conduction velocity, wavefront propagation, and rotational activity formation in atrial fibrillation. Europace. 2024 Oct 3;26(10):euae239. doi: 10.1093/europace/euae239.
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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 (実際)
研究開始
2026年5月19日
一次修了 (推定)
一次修了
2030年12月31日
研究の完了 (推定)
研究の完了
2030年12月31日
試験登録日
最初に提出
最初に提出
2026年7月21日
QC基準を満たした最初の提出物
QC基準を満たした最初の提出物
2026年7月21日
最初の投稿 (実際)
最初の投稿
2026年7月24日
学習記録の更新
投稿された最後の更新 (実際)
投稿された最後の更新
2026年7月24日
QC基準を満たした最後の更新が送信されました
QC基準を満たした最後の更新が送信されました
2026年7月21日
最終確認日
最終確認日
2026年4月1日
詳しくは
本研究に関する用語
キーワード
その他の研究ID番号
その他の研究ID番号
- SMC 2026-02-103
- KCT0011829 (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?
未定
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
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