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

ConditionAtrial Fibrillation (AF)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age19+
SponsorSamsung Medical Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Anatomy-based ablation

    Procedure/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 ablation

    Procedure/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.

Treatment groups

360 Participants
are divided into 2 treatment groups
Group A: Anatomy-based groupActive comparator 1 intervention
Group B: Emphasize map-guided groupExperimental treatment 1 intervention

Trial outcomes

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)

Time frame
From 3 months to 12 months after the index procedure

Secondary outcomes

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.

Time frame
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.

Time frame
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.

Time frame
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

Time frame
From index procedure to 12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Samsung Medical Center

Lead sponsor

Asan Medical Center

Collaborator

Keimyung University Dongsan Medical Center

Collaborator

Korea University Anam Hospital

Collaborator

Source ClinicalTrials.gov
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