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

Recruiting · NCT07726901 · Interventional (participants receive a specific treatment) · Lead sponsor: Samsung Medical Center

View the official record on ClinicalTrials.gov →

Atrial fibrillation

Interventions studied

Anatomy-based ablationEmphasize map-guided ablation

What this trial is about

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.

Who can take part

Age range

19 Years and older

Sex

All (male and female)

Healthy volunteers

No - a diagnosis or condition is required

Phase

Not applicable (e.g. observational or device study)

Study type

Interventional (participants receive a specific treatment)

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.

Where it is running

2 locations listed.

Samsung Medical Center - Seoul, Seoul, South Korea
Samsung Medical Center - Seoul, Seoul, South Korea

Read the full protocol, contacts and eligibility on ClinicalTrials.gov →