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

NARecruitingINTERVENTIONAL
Enrollment

220

Participants

Timeline

Start Date

October 6, 2021

Primary Completion Date

April 30, 2025

Study Completion Date

April 30, 2025

Conditions
Paroxysmal Atrial Fibrillation
Interventions
PROCEDURE

Unipolar voltage subtraction map guided PV isolation group

"1. Pulmonary vein isolation will be performed using a radiofrequency catheter~2. Esophageal temperature will be monitored to prevent esophageal injury~3. Mapping of echocardiographic unipolar voltage subtraction after atrial septal puncture~4. the electrode map data is transferred to the core lab by network to calculate the unipolar voltage subtraction color map (within 10 minutes)~5. Increase radiofrequency ablation time by 2 to 5 seconds in areas with high potential in unipolar voltage subtraction color map~6. Decrease radiofrequency ablation time by 2 to 5 seconds in areas with low potential in unipolar voltage subtraction color map~7. Evaluation of success rate and time of pulmonary vein isolation after bilateral pulmonary vein primary columnar resection~8. Evaluate time to complete isolation after additional ablation~9. Evaluation of Procedure and Ablation time, and perfusion saline dose~10. Rhythm follow-up after the procedure in accordance with the study design."

PROCEDURE

CT myocardial thickness map guided PV isolation group

"1. Pulmonary vein isolation will be performed using a radiofrequency catheter~2. Esophageal temperature will be monitored to prevent esophageal injury.~3. Prepared myocardial thickness map with CT DICOM images conducted prior to procedure.~4. Increase radiofrequency ablation time by 2 to 5 seconds in thick areas in CT myocardial thickness map~5. Decrease radiofrequency ablation time by 2 to 5 seconds in thin areas in CT myocardial thickness map~6. Evaluation of success rate and time of pulmonary vein isolation after bilateral pulmonary vein primary columnar resection~7. Evaluate time to complete isolation after additional ablation~8. Evaluation of Procedure time, Ablation time, and perfusion saline dose~9. Rhythm follow-up will be performed after the procedure in accordance with the aforementioned study design."

PROCEDURE

Empirical PV isolation group

"1. Pulmonary vein isolation will be performed using a radiofrequency catheter~2. Esophageal temperature will be monitored to prevent esophageal injury.~3. The procedure is performed by adjusting radiofrequency energy according to the traditional method and experience of the practitioner.~4. Evaluation of success rate and time of pulmonary vein isolation after bilateral pulmonary vein primary columnar resection~5. Evaluate time to complete isolation after additional ablation~6. Evaluation of Procedure time, Ablation time, and perfusion saline dose~7. Rhythm follow-up will be performed after the procedure in accordance with the aforementioned study design."

Trial Locations (1)

120-752

RECRUITING

Severance Cardiovascular Hospital, Yonsei University Health System, Seoul

All Listed Sponsors
lead

Yonsei University

OTHER