NCT07068646Not yet recruiting
Thickness Map-Guided vs. Empirical PV Isolation Using Pulsed Field Ablation for Paroxysmal AF
Computed Tomogram Myocardial Thickness Map-Guided Pulmonary Vein Isolation vs. Empirical Pulmonary Vein Isolation in Pulse-Field Ablation for Paroxysmal Atrial Fibrillation (UTMOST AF III)
Source: ClinicalTrials.gov · Last updated 16 Jul 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
This is a prospective, multicenter, randomized controlled trial comparing CT-guided versus empirical pulsed field ablation (PFA) for pulmonary vein isolation in patients with paroxysmal atrial fibrillation. The study investigates whether atrial wall thickness-based energy titration improves arrhythmia outcomes compared to standard empirical ablation using the PulseSelect™ system.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 298 (estimated)
- First submitted
- 7 Jul 2025
- Start date
- 1 Aug 2025
- Primary completion date
- 31 Jul 2029
- Lead sponsor
- Yonsei University
- Diseases
- Atrial fibrillation
- NCT number
- NCT07068646
What you commit to
- Study type: Interventional
- Planned participants: 298
- From 1 Aug 2025 to the primary completion date, 31 Jul 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients with contraindications for anticoagulation therapy(for prevention of cerebral infarction) and antiarrhythmic drugs
- Drug addicts or alcoholics
Other illness
- Atrial fibrillation associated with severe cardiac malformation or a structural heart disease that is hemodynamically affected
- Patients with severe renal impairment or CT imaging difficulty using contrast media
- Patients with a past history of radiofrequency ablation for atrial fibrillation or other cardiac surgery
- Patients with active internal bleeding
- Patients with a severe comorbid disease
Other
- Patients with persistent or permanent atrial fibrillation
- Patients with valvular atrial fibrillation (mitral stenosis \>grade 2, mechanical valve, mitral valvuloplasty)
- Expected survival \< 1 year
- Patients who cannot read the consent form (illiterates, foreigners, etc.)
- Other patients who are judged by the principal or sub-investigator to be ineligible for participation in this clinical study
Criteria the registry did not label
- Patient with paroxysmal atrial fibrillation who is scheduled for ablation procedure and ≥19 and ≤80 years of age
- Left atrium size \< 50mm
- paroxysmal atrial fibrillation that is recurrence during antiarrhythmic drug treatment or is not able to use an antiarrhythmic drug.
- Patient who is indicated for anticoagulation therapy (for prevention of cerebral infarction)
Age in the registry: 19 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Severance hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.