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Atrial Fibrillation (AF)COMPASS-AFNCT07726901

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

A study testing Anatomy-based ablation and Emphasize map-guided ablation in people with Atrial Fibrillation (AF), run by Samsung Medical Center at 2 sites in South Korea.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 19 years and older
Conditions the study is for
Atrial Fibrillation (AF)
What is being tested?
Anatomy-based ablation and Emphasize map-guided ablation
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
360 participants
Where
2 sitesSouth Korea
Study dates
19 May 2026to 31 Dec 2030
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 9Show fewer
  • 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.

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Ju Youn Kim, Ph.D contact

82+ 2-3410-3419

kzzoo921@gmail.com

South Korea2 sites, 2 recruiting

  • Samsung Medical Center

    Seoul, Seoul, 06351

    Ju Youn Kim, Ph.D, 82+ 2-3410-3419, kzzoo921@gmail.com

    Not yet recruiting

  • Samsung Medical Center

    Seoul, Seoul, 06351

    Ju Youn Kim, Ph.D, 82+ 2-3410-3419, kzzoo921@gmail.com

    Recruiting

Other trials in South Korea

About this study

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.

Read the detailed description

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.

Being tested
Anatomy-based ablation, Emphasize map-guided ablation
Keywords
Emphasize map
Medical subject headings
Atrial Fibrillation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Anatomy-based ablationProcedure or surgery

    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.

  • Emphasize map-guided ablationProcedure or surgery

    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.

Study groups in NCT07726901
Study groupRoleWhat they receive
Anatomy-based groupActive comparatorNot described
Receives: Procedure: Anatomy-based ablation
Emphasize map-guided groupExperimentalNot described
Receives: Procedure: Emphasize map-guided ablation

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

    Measured: From 3 months to 12 months after the index procedure

Secondary outcomes (12)

  1. Atrial fibrillation burden

    The proportion of time spent in atrial fibrillation or atrial flutter during rhythm monitoring .The burden will be assessed as percent(%) using Holter monitoring.

    Measured: From 3 months to 12 months after the index procedure

  2. Repeat ablation

    Any additional catheter ablation procedure performed after the index procedure for documented recurrent atrial tachyarrhythmia during the follow-up period.

    Measured: From index procedure to 12 months

  3. Use of antiarrhythmic drug therapy

    Percentage of patients prescribed any Class I or Class III antiarrhythmic Temporary use during the blanking period (first 3 months) will not be counted.

    Measured: From 3 months to 12 months after the index procedure

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

    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

    Measured: From index procedure to 12 months

  5. Stroke

    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.

    Measured: From index procedure to 12 months

  6. Cardiovascular hospitalization

    Proportion of participants experiencing hospitalization primarily due to a cardiovascular cause, including:

    • Atrial tachyarrhythmia recurrence
    • Heart failure exacerbation
    • Acute coronary syndrome
    • Cardiovascular procedural complications

    Measured: From index procedure to 12 months

  7. Bleeding event

    Proportion of participants experiencing bleeding events.

    Bleeding event will be classified according to the International Society on Thrombosis and Haemostasis(ISTH) criteria:

    • Major bleeding
    • Clinically relevant non-major bleeding

    Measured: From index procedure to 12 months

  8. All-cause mortality

    Death due to any cause occurring during the follow-up period.

    Measured: From index procedure to 12 months

  9. Procedure-related complications

    Proportion of participants experiencing any complication occurring during or within 30 days after the index procedure, including:

    • Cardiac tamponade
    • Vascular access complication
    • Pulmonary vein stenosis
    • Esophageal injury
    • Phrenic nerve injury
    • Major bleeding.

    Measured: From index procedure to 30days

  10. Procedure time

    Total procedure time measured in minutes from vascular access puncture to removal of all catheters at the end of the procedure.

    Measured: at the index procedure

  11. Radiation time

    Total fluoroscopy exposure time measured in minutes.

    Measured: at the index procedure

  12. Left atrial reservoir strain

    Measured as percentage by echocardiography

    Measured: From index procedure to 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Jul 2026
  2. Study start19 May 2026
  3. Primary completion31 Dec 2030 (estimated)
  4. Study completion31 Dec 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
360 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07726901
Sponsor's protocol ID
SMC 2026-02-103
Other IDs
KCT0011829
Acronym
COMPASS-AF
Status last verified
Apr 2026
First submitted
21 Jul 2026
Last updated
24 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 40321733

  • 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.

    PubMed 39283961

  • 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.

    PubMed 25946280

  • 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.

    PubMed 35863814

  • 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.

    PubMed 38319851

  • 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.

    PubMed 40306839

  • 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.

    PubMed 39809414

  • 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.

    PubMed 38967398

  • 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.

    PubMed 36625809

  • 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.

    PubMed 33185144

  • 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.

    PubMed 32022320

  • 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.

    PubMed 28506916

  • 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

Questions about this trial

What is this clinical trial studying?

A study testing Anatomy-based ablation and Emphasize map-guided ablation in people with Atrial Fibrillation (AF), run by Samsung Medical Center at 2 sites in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 24 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Ju Youn Kim, Ph.D (82+ 2-3410-3419, kzzoo921@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Recurrence of atrial tachyarrhythmia (time frame: From 3 months to 12 months after the index procedure). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07726901, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2026.

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