Empirical Anatomy-Based Ablation vs Emphasize Map-Guided Substrate Ablation in Persistent Atrial Fibrillation : (COMPASS-AF) (COMPASS-AF)
21. července 2026 aktualizováno: 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.
Přehled studie
Postavení
Nábor
Podmínky
Intervence / Léčba
Detailní popis
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.
Typ studie
Intervenční
Zápis (Odhadovaný)
360
Fáze
- Nelze použít
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní kontakt
- Jméno: Ju Youn Kim, Ph.D
- Telefonní číslo: 82+ 2-3410-3419
- E-mail: kzzoo921@gmail.com
Studijní místa
-
-
Seoul
-
Seoul, Seoul, Jižní Korea, 06351
- Nábor
- Samsung Medical Center
-
Kontakt:
- Ju Youn Kim, Ph.D
- Telefonní číslo: 82+ 2-3410-3419
- E-mail: kzzoo921@gmail.com
-
Seoul, Seoul, Jižní Korea, 06351
- Zatím nenabíráme
- Samsung Medical Center
-
Kontakt:
- Ju Youn Kim, Ph.D
- Telefonní číslo: 82+ 2-3410-3419
- E-mail: kzzoo921@gmail.com
-
-
Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Ne
Popis
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.
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Aktivní komparátor: 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.
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Experimentální: 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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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Recurrence of atrial tachyarrhythmia
Časové okno: 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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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Atrial fibrillation burden
Časové okno: 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.
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From 3 months to 12 months after the index procedure
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Repeat ablation
Časové okno: 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
Časové okno: 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.
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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
Časové okno: 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
|
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Stroke
Časové okno: 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
|
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Cardiovascular hospitalization
Časové okno: From index procedure to 12 months
|
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
Časové okno: 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:
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From index procedure to 12 months
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All-cause mortality
Časové okno: From index procedure to 12 months
|
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
Časové okno: From index procedure to 30days
|
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
Časové okno: 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.
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at the index procedure
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Radiation time
Časové okno: at the index procedure
|
Total fluoroscopy exposure time measured in minutes.
|
at the index procedure
|
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Left atrial reservoir strain
Časové okno: From index procedure to 12 months
|
Measured as percentage by echocardiography
|
From index procedure to 12 months
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Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Publikace a užitečné odkazy
Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.
Obecné publikace
- 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
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Aktuální)
19. května 2026
Primární dokončení (Odhadovaný)
31. prosince 2030
Dokončení studie (Odhadovaný)
31. prosince 2030
Termíny zápisu do studia
První předloženo
21. července 2026
První předloženo, které splnilo kritéria kontroly kvality
21. července 2026
První zveřejněno (Aktuální)
24. července 2026
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
24. července 2026
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
21. července 2026
Naposledy ověřeno
1. dubna 2026
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- SMC 2026-02-103
- KCT0011829 (Jiný identifikátor: Korea National Institute of Health)
Plán pro data jednotlivých účastníků (IPD)
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