Empirical Anatomy-Based Ablation vs Emphasize Map-Guided Substrate Ablation in Persistent Atrial Fibrillation : (COMPASS-AF)

NCT07726901 | Recruiting

• 2 other identifiers: SMC 2026-02-103KCT0011829
• Study Type: interventional
• Target: 360
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Atrial Fibrillation (AF)

Keywords

Emphasize map

Outcome Measures

Primary Outcomes (1)

• Recurrence of atrial tachyarrhythmia

  Any documented atrial tachyarrhythmias excluding the initial 3-month blanking period. Documented atrial tachyarrhythmias (atrial fibrillation, atrial flutter, atrial tachycardia) were defined as follows: * Atrial tachyarrhythmias documented in 12 lead ECG * Atrial tachyarrhythmias of more than 30 seconds in Holter monitoring Recorded as a binary outcome (presence or absence of recurrence)

  From 3 months to 12 months after the index procedure

Secondary Outcomes (12)

• Atrial fibrillation burden

  From 3 months to 12 months after the index procedure

• Repeat ablation

  From index procedure to 12 months

• Use of antiarrhythmic drug therapy

  From 3 months to 12 months after the index procedure

• Atrial Fibrillation Effect on Quality-of-life (AFEQT) questionnaire score

  From index procedure to 12 months

• Stroke

  From index procedure to 12 months

Study Arms (2)

Anatomy-based group

ACTIVE COMPARATOR

Procedure: Anatomy-based ablation

Emphasize map-guided group

EXPERIMENTAL

Procedure: Emphasize map-guided ablation

Interventions

Anatomy-based ablation PROCEDURE

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.

Anatomy-based group

Emphasize map-guided ablation PROCEDURE

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.

Emphasize map-guided group

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Samsung Medical Center: lead
• Korea University Anam Hospital: collaborator
• Asan Medical Center: collaborator
• Keimyung University Dongsan Medical Center: collaborator

Study Sites (2)

Samsung Medical Center

Seoul, Seoul, 06351, South Korea

NOT YET RECRUITING

Samsung Medical Center

Seoul, Seoul, 06351, South Korea

RECRUITING

Related Publications (13)

• 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.

  PMID: 40321733 RESULT

• 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.

  PMID: 39283961 RESULT

• 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.

  PMID: 25946280 RESULT

• 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.

  PMID: 35863814 RESULT

• 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.

  PMID: 38319851 RESULT

• 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.

  PMID: 40306839 RESULT

• 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.

  PMID: 39809414 RESULT

• 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.

  PMID: 38967398 RESULT

• 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.

  PMID: 36625809 RESULT

• 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.

  PMID: 33185144 RESULT

• 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.

  PMID: 32022320 RESULT

• 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.

  PMID: 28506916 RESULT

• 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

  RESULT

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Ju Youn Kim, Ph.D

CONTACT

82+ 2-3410-3419; kzzoo921@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 21, 2026
• First Posted: July 24, 2026
• Study Start: May 19, 2026
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2030
• Last Updated: July 24, 2026

Record last verified: 2026-04

Locations

KR (2)