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

Last Updated: 2024-06-13

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 220 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-06
• Study Completion Date: 2025-04-30

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.

Detailed Description

A. Study design

1. Prospective randomization (Unipolar voltage subtraction map guided PV(pulmonary vein) isolation group vs. CT myocardial thickness map guided PV isolation group vs. Empirical PV isolation group )

2. Target number of subjects: 480 (160 per group)

3. Rhythm FU : 2012 ACC/AHA/ESC guidelines (Holter monitoring at the baseline, 2 month, and thereafter every 6 months; ECG if the patient has any symptom)

4. Anticoagulant therapy followed by 2014 ACC/AHA/ESC guidelines

5. All complications in each group will be evaluated including the re-hospitalization rate, major cardiovascular event, and mortality rate.

B. Progress and rhythm/ECG follow-up

1. To be performed in accordance with the 2012 ACC/AHA/HRS guidelines for AF management

2. Follow-up at 1 weeks, 3 months, and thereafter every 6-month after procedure.

3. Rhythm control at 3 months, and thereafter every 6-month follow-up with Holter

4. If the patient complains of symptoms, ECG will be performed at any time, and rhythm follow-up will be carried out with a Holter or event recorder.

C. Follow-up All the patients will be followed-up at 1, 3, 6 months, and thereafter every 6 months. If the patient shows any symptom within the clinical study period, patient will visit the outpatient clinic. ECG will be performed at every outpatient visits, and 24-hour Holter or event recording will be performed every 6 months for 2 years, and every year after 2 years (2012 Heart Rhythm Society/EHRA/European Cardiac Arrhythmia Society Expert Consensus Statement guidelines). If atrial fibrillation or atrial tachycardia lasting more than 30 seconds is observed in 12-lead ECG or Holter, it will be evaluated as recurrence. Recurrence within 3 months after the procedure will be classified as early recurrence, and that after 3 months will be classified as clinical recurrence.

Conditions

Paroxysmal Atrial Fibrillation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Unipolar voltage subtraction map guided PV isolation group

Intervention Type: PROCEDURE

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.

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.

Group Type: EXPERIMENTAL

CT myocardial thickness map guided PV isolation group

Intervention Type: PROCEDURE

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.

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.

Group Type: ACTIVE_COMPARATOR

Empirical PV isolation group

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yonsei University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Severance Cardiovascular Hospital, Yonsei University Health System

Seoul, , South Korea

Site Status: RECRUITING

Countries

South Korea

Facility Contacts

Hui-Nam Pak, M.D., Ph.D.

Role: primary

hnpak@yuhs.ac

82-2-2228-8459

Other Identifiers

4-2019-0109

Identifier Type: -

Identifier Source: org_study_id