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

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.

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.

Sponsors & Collaborators

• Yonsei University

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

20 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-10-06

Primary Completion

2025-04-30

Completion

2025-04-30

Countries

• South Korea

Study Locations