NCT03912324 Computed Tomogram Myocardial Thickness Map Guided pulmOnary Vein iSolaTion vs. Empirical Pulmonary Vein Isolation in Cryoballoon Ablation for Paroxysmal Atrial Fibrillation (UTMOST AF II)
| NCT ID | NCT03912324 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Yonsei University |
| Condition | Paroxysmal Atrial Fibrillation |
| Study Type | INTERVENTIONAL |
| Enrollment | 220 participants |
| Start Date | 2021-10-06 |
| Primary Completion | 2025-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 220 participants in total. It began in 2021-10-06 with a primary completion date of 2025-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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
Frequently Asked Questions
Who can join the NCT03912324 clinical trial?
This trial is open to participants of all sexes, aged 20 Years or older, up to 80 Years, studying Paroxysmal Atrial Fibrillation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03912324 currently recruiting?
Yes, NCT03912324 is actively recruiting participants. Visit ClinicalTrials.gov or contact Yonsei University to inquire about joining.
Where is the NCT03912324 trial being conducted?
This trial is being conducted at Seoul, South Korea.
Who is sponsoring the NCT03912324 clinical trial?
NCT03912324 is sponsored by Yonsei University. The trial plans to enroll 220 participants.
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