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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20-80
SponsorYonsei University

About this trial

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

Qualifiers

Patient with paroxysmal atrial fibrillation who is scheduled for ablation procedure and ≥20 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)

Disqualifiers

Patients with persistent or permanent atrial fibrillation

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

Trial design

Treatments tested in this trial

  • Unipolar voltage subtraction map guided PV isolation group
  • CT myocardial thickness map guided PV isolation group
  • Empirical PV isolation group

Treatment groups

220 Participants
are divided into 3 treatment groups

Sponsors and collaborators