Empirical Anatomy-Based Ablation vs Emphasize Map-Guided Substrate Ablation in Persistent Atrial Fibrillation : (COMPASS-AF) (COMPASS-AF)
2026년 7월 21일 업데이트: 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.
연구 개요
상태
상태
모병
정황
정황
개입 / 치료
개입 / 치료
상세 설명
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.
연구 유형
연구 유형
중재적
등록 (추정된)
등록
360
단계
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
연구 연락처
- 이름: Ju Youn Kim, Ph.D
- 전화번호: 82+ 2-3410-3419
- 이메일: kzzoo921@gmail.com
연구 장소
-
-
Seoul
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Seoul, Seoul, 대한민국, 06351
- 모병
- Samsung Medical Center
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연락하다:
- Ju Youn Kim, Ph.D
- 전화번호: 82+ 2-3410-3419
- 이메일: kzzoo921@gmail.com
-
Seoul, Seoul, 대한민국, 06351
- 아직 모집하지 않음
- Samsung Medical Center
-
연락하다:
- Ju Youn Kim, Ph.D
- 전화번호: 82+ 2-3410-3419
- 이메일: kzzoo921@gmail.com
-
-
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
설명
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.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
팔의 수
2
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
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활성 비교기: Anatomy-based group
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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.
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실험적: Emphasize map-guided group
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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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연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Recurrence of atrial tachyarrhythmia
기간: From 3 months to 12 months after the index procedure
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Any documented atrial tachyarrhythmias excluding the initial 3-month blanking period. Documented atrial tachyarrhythmias (atrial fibrillation, atrial flutter, atrial tachycardia) were defined as follows:
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From 3 months to 12 months after the index procedure
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2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Atrial fibrillation burden
기간: From 3 months to 12 months after the index procedure
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The proportion of time spent in atrial fibrillation or atrial flutter during rhythm monitoring .The burden will be assessed as percent(%) using Holter monitoring.
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From 3 months to 12 months after the index procedure
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Repeat ablation
기간: From index procedure to 12 months
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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
기간: From 3 months to 12 months after the index procedure
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Percentage of patients prescribed any Class I or Class III antiarrhythmic Temporary use during the blanking period (first 3 months) will not be counted.
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From 3 months to 12 months after the index procedure
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Atrial Fibrillation Effect on Quality-of-life (AFEQT) questionnaire score
기간: From index procedure to 12 months
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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
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From index procedure to 12 months
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Stroke
기간: From index procedure to 12 months
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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.
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From index procedure to 12 months
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Cardiovascular hospitalization
기간: From index procedure to 12 months
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Proportion of participants experiencing hospitalization primarily due to a cardiovascular cause, including:
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From index procedure to 12 months
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Bleeding event
기간: From index procedure to 12 months
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Proportion of participants experiencing bleeding events. Bleeding event will be classified according to the International Society on Thrombosis and Haemostasis(ISTH) criteria:
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From index procedure to 12 months
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All-cause mortality
기간: From index procedure to 12 months
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Death due to any cause occurring during the follow-up period.
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From index procedure to 12 months
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Procedure-related complications
기간: From index procedure to 30days
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Proportion of participants experiencing any complication occurring during or within 30 days after the index procedure, including:
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From index procedure to 30days
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Procedure time
기간: at the index procedure
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Total procedure time measured in minutes from vascular access puncture to removal of all catheters at the end of the procedure.
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at the index procedure
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Radiation time
기간: at the index procedure
|
Total fluoroscopy exposure time measured in minutes.
|
at the index procedure
|
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Left atrial reservoir strain
기간: From index procedure to 12 months
|
Measured as percentage by echocardiography
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From index procedure to 12 months
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
협력자
협력자
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
- Verma A, Jiang CY, Betts TR, Chen J, Deisenhofer I, Mantovan R, Macle L, Morillo CA, Haverkamp W, Weerasooriya R, Albenque JP, Nardi S, Menardi E, Novak P, Sanders P; STAR AF II Investigators. Approaches to catheter ablation for persistent atrial fibrillation. N Engl J Med. 2015 May 7;372(19):1812-22. doi: 10.1056/NEJMoa1408288.
- Calkins H, Hindricks G, Cappato R, Kim YH, Saad EB, Aguinaga L, Akar JG, Badhwar V, Brugada J, Camm J, Chen PS, Chen SA, Chung MK, Nielsen JC, Curtis AB, Davies DW, Day JD, d'Avila A, de Groot NMSN, Di Biase L, Duytschaever M, Edgerton JR, Ellenbogen KA, Ellinor PT, Ernst S, Fenelon G, Gerstenfeld EP, Haines DE, Haissaguerre M, Helm RH, Hylek E, Jackman WM, Jalife J, Kalman JM, Kautzner J, Kottkamp H, Kuck KH, Kumagai K, Lee R, Lewalter T, Lindsay BD, Macle L, Mansour M, Marchlinski FE, Michaud GF, Nakagawa H, Natale A, Nattel S, Okumura K, Packer D, Pokushalov E, Reynolds MR, Sanders P, Scanavacca M, Schilling R, Tondo C, Tsao HM, Verma A, Wilber DJ, Yamane T. 2017 HRS/EHRA/ECAS/APHRS/SOLAECE expert consensus statement on catheter and surgical ablation of atrial fibrillation. Heart Rhythm. 2017 Oct;14(10):e275-e444. doi: 10.1016/j.hrthm.2017.05.012. Epub 2017 May 12. No abstract available.
- Kistler PM, Chieng D, Sugumar H, Ling LH, Segan L, Azzopardi S, Al-Kaisey A, Parameswaran R, Anderson RD, Hawson J, Prabhu S, Voskoboinik A, Wong G, Morton JB, Pathik B, McLellan AJ, Lee G, Wong M, Finch S, Pathak RK, Raja DC, Sterns L, Ginks M, Reid CM, Sanders P, Kalman JM. Effect of Catheter Ablation Using Pulmonary Vein Isolation With vs Without Posterior Left Atrial Wall Isolation on Atrial Arrhythmia Recurrence in Patients With Persistent Atrial Fibrillation: The CAPLA Randomized Clinical Trial. JAMA. 2023 Jan 10;329(2):127-135. doi: 10.1001/jama.2022.23722.
- Al-Aidarous S, Horrach CV, Roney C, Butcher C, Hunter RJ, Honarbakhsh S. Peak frequency can be effectively used to characterize scar in atrial fibrillation. Heart Rhythm O2. 2025 Jan 9;6(4):434-443. doi: 10.1016/j.hroo.2024.12.011. eCollection 2025 Apr.
- 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.
- Yang G, Zheng L, Jiang C, Fan J, Liu X, Zhan X, Li J, Wang L, Yang H, Zhu W, Du H, Ma G, Ma W, Kojodjojo P, Chen M; STABLE-SR-II Investigators. Circumferential Pulmonary Vein Isolation Plus Low-Voltage Area Modification in Persistent Atrial Fibrillation: The STABLE-SR-II Trial. JACC Clin Electrophysiol. 2022 Jul;8(7):882-891. doi: 10.1016/j.jacep.2022.03.012. Epub 2022 Apr 27.
- Huo Y, Gaspar T, Schonbauer R, Wojcik M, Fiedler L, Roithinger FX, Martinek M, Purerfellner H, Kirstein B, Richter U, Ulbrich S, Mayer J, Krahnefeld O, Agdirlioglu T, Zedda A, Piorkowski J, Piorkowski C. Low-Voltage Myocardium-Guided Ablation Trial of Persistent Atrial Fibrillation. NEJM Evid. 2022 Nov;1(11):EVIDoa2200141. doi: 10.1056/EVIDoa2200141. Epub 2022 Oct 19.
- Reddy VY, Gerstenfeld EP, Schmidt B, Nair D, Natale A, Saliba W, Verma A, Sommer P, Metzner A, Turagam M, Weiner S, Champagne J, Garcio-Bolao I, Calkins H, Olson J, Issa Z, Winner M, Su W, Tomassoni G, Kim J, Hook B, Delurgio DB, Gibson DN, Daccarett M, Patel C, Bhalla K, Shehata M, Harding JD, Cheung JW, Raybuck JD, Roelke S, Schwartz T, Sutton BS, Mansour M; ADVANTAGE-AF Investigators. Pulsed Field Ablation for Persistent Atrial Fibrillation: 1-Year Results of ADVANTAGE AF. J Am Coll Cardiol. 2025 May 6;85(17):1664-1678. doi: 10.1016/j.jacc.2025.03.515.
- Casula M, Scajola LV, Quilico F, Pasotti B, Cesarano E, Sanzo A, Savastano S, Rordorf R. Posterior left atrial wall isolation for treatment of persistent atrial fibrillation during first-time catheter ablation: An updated systematic review and meta-analysis. Int J Cardiol. 2025 Mar 1;422:132987. doi: 10.1016/j.ijcard.2025.132987. Epub 2025 Jan 12.
- Ibrahim AA, Elaraby A, Almaadawy O, Abuelazm M, Hassan AR, Bakr A, Husain MA, Elsayed H, Abdelazeem B. Adjunctive left atrial posterior wall isolation for atrial fibrillation: An updated systematic review and meta-analysis. Pacing Clin Electrophysiol. 2024 Aug;47(8):1108-1123. doi: 10.1111/pace.15035. Epub 2024 Jul 5.
- DeLurgio DB, Crossen KJ, Gill J, Blauth C, Oza SR, Magnano AR, Mostovych MA, Halkos ME, Tschopp DR, Kerendi F, Taigen TL, Shults CC, Shah MH, Rajendra AB, Osorio J, Silver JS, Hook BG, Gilligan DM, Calkins H. Hybrid Convergent Procedure for the Treatment of Persistent and Long-Standing Persistent Atrial Fibrillation: Results of CONVERGE Clinical Trial. Circ Arrhythm Electrophysiol. 2020 Dec;13(12):e009288. doi: 10.1161/CIRCEP.120.009288. Epub 2020 Nov 13.
- Terricabras M, Verma A. Is pulmonary vein isolation enough for persistent atrial fibrillation? J Cardiovasc Electrophysiol. 2020 Aug;31(8):2148-2153. doi: 10.1111/jce.14381. Epub 2020 Feb 14.
- Lee S-R, Kim D, Lee SH, Lim W-H, Chun KJ, Choe W-S, Ahn H-J, Lee K-Y, Choi J, Kim B-S, et al. Atrial fibrillation fact sheet in Korea 2024 (part 1): epidemiology of atrial fibrillation in Korea. International Journal of Arrhythmia. 2024;25:13. doi: 10.1186/s42444-024-00119-4
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
연구 시작
2026년 5월 19일
기본 완료 (추정된)
기본 완료
2030년 12월 31일
연구 완료 (추정된)
연구 완료
2030년 12월 31일
연구 등록 날짜
최초 제출
최초 제출
2026년 7월 21일
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
2026년 7월 21일
처음 게시됨 (실제)
처음 게시됨
2026년 7월 24일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
2026년 7월 24일
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
2026년 7월 21일
마지막으로 확인됨
마지막으로 확인됨
2026년 4월 1일
추가 정보
이 연구와 관련된 용어
키워드
기타 연구 ID 번호
기타 연구 ID 번호
- SMC 2026-02-103
- KCT0011829 (기타 식별자: Korea National Institute of Health)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
미정
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .