Empirical Anatomy-Based Ablation vs Emphasize Map-Guided Substrate Ablation in Persistent Atrial Fibrillation : (COMPASS-AF) (COMPASS-AF)
21 juli 2026 uppdaterad av: 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.
Studieöversikt
Status
Rekrytering
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Beräknad)
360
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Ju Youn Kim, Ph.D
- Telefonnummer: 82+ 2-3410-3419
- E-post: kzzoo921@gmail.com
Studieorter
-
-
Seoul
-
Seoul, Seoul, Sydkorea, 06351
- Rekrytering
- Samsung Medical Center
-
Kontakt:
- Ju Youn Kim, Ph.D
- Telefonnummer: 82+ 2-3410-3419
- E-post: kzzoo921@gmail.com
-
Seoul, Seoul, Sydkorea, 06351
- Har inte rekryterat ännu
- Samsung Medical Center
-
Kontakt:
- Ju Youn Kim, Ph.D
- Telefonnummer: 82+ 2-3410-3419
- E-post: kzzoo921@gmail.com
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Beskrivning
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.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: 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.
|
|
Experimentell: 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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Recurrence of atrial tachyarrhythmia
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Atrial fibrillation burden
Tidsram: 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
Tidsram: 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.
|
From index procedure to 12 months
|
|
Use of antiarrhythmic drug therapy
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: at the index procedure
|
Total fluoroscopy exposure time measured in minutes.
|
at the index procedure
|
|
Left atrial reservoir strain
Tidsram: From index procedure to 12 months
|
Measured as percentage by echocardiography
|
From index procedure to 12 months
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Allmänna publikationer
- 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
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
19 maj 2026
Primärt slutförande (Beräknad)
31 december 2030
Avslutad studie (Beräknad)
31 december 2030
Studieregistreringsdatum
Först inskickad
21 juli 2026
Först inskickad som uppfyllde QC-kriterierna
21 juli 2026
Första postat (Faktisk)
24 juli 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
24 juli 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
21 juli 2026
Senast verifierad
1 april 2026
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- SMC 2026-02-103
- KCT0011829 (Annan identifierare: Korea National Institute of Health)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
OBESLUTSAM
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .