Guided pulmonary vein isolation for treating paroxysmal atrial fibrillation

Computed Tomogram Myocardial Thickness Map Guided pulmOnary Vein iSolaTion vs. Empirical Pulmonary Vein Isolation in Cryoballoon Ablation for Paroxysmal Atrial Fibrillation (UTMOST AF II)

This study is testing three different methods of using radiofrequency energy to treat paroxysmal atrial fibrillation in 480 people to see which approach works best for their individual heart tissue.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 220 (estimated)
• Ages: 20 Years to 80 Years
• Sex: All
• Sponsor: Yonsei University (Academic / other)
• Locations: 1 site (Seoul)
• Trial ID: NCT03912324 on ClinicalTrials.gov

What this trial studies

This study evaluates the efficacy and safety of radiofrequency energy therapy for paroxysmal atrial fibrillation by comparing three approaches: unipolar voltage subtraction map guided pulmonary vein isolation, CT myocardial thickness map guided pulmonary vein isolation, and empirical pulmonary vein isolation. A total of 480 participants will be randomly assigned to one of the three groups, with follow-up assessments including Holter monitoring and ECGs to track rhythm and complications. The study aims to personalize treatment based on individual atrial tissue characteristics, potentially improving outcomes for patients undergoing ablation procedures.

Who should consider this trial

Good fit: Ideal candidates are adults aged 20 to 80 with paroxysmal atrial fibrillation who are scheduled for an ablation procedure.

Not a fit: Patients with persistent or permanent atrial fibrillation or those with severe cardiac malformations may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to more effective and personalized treatments for patients with paroxysmal atrial fibrillation.

How similar studies have performed: While there have been studies on pulmonary vein isolation, this specific approach using myocardial thickness mapping is novel and has not been extensively tested.

Eligibility criteria

Inclusion Criteria:

1. Patient with paroxysmal atrial fibrillation who is scheduled for ablation procedure and ≥20 and ≤80 years of age
2. Left atrium size \< 50mm
3. paroxysmal atrial fibrillation that is recurrence during antiarrhythmic drug treatment or is not able to use an antiarrhythmic drug.
4. Patient who is indicated for anticoagulation therapy (for prevention of cerebral infarction)

Exclusion Criteria:

1. Patients with persistent or permanent atrial fibrillation
2. Atrial fibrillation associated with severe cardiac malformation or a structural heart disease that is hemodynamically affected
3. Patients with severe renal impairment or CT imaging difficulty using contrast media
4. Patients with a past history of radiofrequency ablation for atrial fibrillation or other cardiac surgery
5. Patients with active internal bleeding
6. Patients with contraindications for anticoagulation therapy(for prevention of cerebral infarction) and antiarrhythmic drugs
7. Patients with valvular atrial fibrillation (mitral stenosis \>grade 2, mechanical valve, mitral valvuloplasty)
8. Patients with a severe comorbid disease
9. Expected survival \< 1 year
10. Drug addicts or alcoholics
11. Patients who cannot read the consent form (illiterates, foreigners, etc.)
12. Other patients who are judged by the principal or sub-investigator to be ineligible for participation in this clinical study

Where this trial is running

Seoul

• Severance Cardiovascular Hospital, Yonsei University Health System — Seoul, South Korea (Recruiting)

Conditions Paroxysmal Atrial Fibrillation; Atrial fibrillation; Pulmonary vein isolation