Actively Recruiting
Computed Tomogram Myocardial Thickness Map Guided pulmOnary Vein iSolaTion vs. Empirical Pulmonary Vein Isolation in Cryoballoon Ablation for Paroxysmal Atrial Fibrillation (UTMOST AF II)
Led by Yonsei University · Updated on 2024-06-13
220
Participants Needed
1
Research Sites
181 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
New parameters or methods, such as ablation index, have been developed for the quantification of high-frequency energy used in pulmonary vein isolation, but there is no known method for atrial fibrillation considering individual differences in atrial tissue. The atrium is only 1/3 of the thickness of the ventricle and is thinner in women and older than men or young people. The aim of this study was to evaluate the efficacy and safety of radiofrequency energy therapy using atrial individual differences. In order to reflect the thickness of the atrium, we will use the unipolar and bipolar maps and the myocardial thickness map using computed tomography (CT) images. To evaluate the efficacy and safety of energy titration therapy by random assignment of high frequency energy therapy group, CT image application high frequency energy therapy group, and existing empirical high frequency therapy group.
CONDITIONS
Official Title
Computed Tomogram Myocardial Thickness Map Guided pulmOnary Vein iSolaTion vs. Empirical Pulmonary Vein Isolation in Cryoballoon Ablation for Paroxysmal Atrial Fibrillation (UTMOST AF II)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient with paroxysmal atrial fibrillation scheduled for ablation and aged between 20 and 80 years
- Left atrium size less than 50 mm
- Paroxysmal atrial fibrillation that recurs during antiarrhythmic drug treatment or inability to use antiarrhythmic drugs
- Indicated for anticoagulation therapy to prevent cerebral infarction
You will not qualify if you...
- Persistent or permanent atrial fibrillation
- Atrial fibrillation with severe cardiac malformation or structural heart disease affecting heart function
- Severe kidney impairment or difficulty undergoing CT imaging with contrast
- Past radiofrequency ablation for atrial fibrillation or other heart surgery
- Active internal bleeding
- Contraindications for anticoagulation or antiarrhythmic drugs
- Valvular atrial fibrillation (mitral stenosis over grade 2, mechanical valve, or mitral valvuloplasty)
- Severe comorbid diseases
- Expected survival less than 1 year
- Drug addiction or alcoholism
- Unable to read the consent form (illiteracy, foreign language barrier, etc.)
- Other conditions judged by investigators as making participation unsuitable
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Severance Cardiovascular Hospital, Yonsei University Health System
Seoul, South Korea, 120-752
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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