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

NCT03912324 | Recruiting DMC

• 1 other identifier: 4-2019-0109
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 1

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.

Conditions

Paroxysmal Atrial Fibrillation

Keywords

Atrial fibrillation; Pulmonary vein isolation

Outcome Measures

Primary Outcomes (4)

• Safety evaluation: Procedure-related cardiac complication rate

  including open cardiac surgery, cerebral infarction, pericardial effusion or cardiac tamponade, hematoma in the inguinal puncture site and vascular complications within 30 days post procedure.

  within 30 days post procedure

• Efficacy evaluation: Atrial fibrillation or atrial tachycardia for at least 30 seconds after 3 months within 1 year without antiarrhythmic medication

  Defined as atrial fibrillation or atrial tachycardia \> 30 sec after 3 months within 1 year; based on the 2012 ACC/AHA/HRS guidelines, 24-hour Holter ECG monitoring will be performed at 2 month and every 6 months, and ECG and monitoring with a Holter or an event recorder will be performed at any time if the patient complains of symptoms

  Within 1 year after 3 months of procedure

• Efficacy evaluation: Major cardiovascular event rate

  death, myocardial infarction, coronary angioplasty, and re-hospitalization for arrhythmia and heart failure

  immediate after procedure

• Efficacy evaluation: Major cardiovascular event rate

  death, myocardial infarction, coronary angioplasty, and re-hospitalization for arrhythmia and heart failure

  12 months after procedure

Secondary Outcomes (24)

• Comparison of procedure time

  immediate after procedure

• Comparison of ablation time

  immediate after procedure

• Comparison of hospitalization period

  immediate after procedure

• Comparison of anti-arrhythmic drug or anticoagulation therapy related complication rate

  1 week after procedure

• Comparison of anti-arrhythmic drug or anticoagulation therapy related complication rate

  3 months after procedure

Study Arms (3)

Unipolar voltage subtraction map guided PV isolation group

EXPERIMENTAL

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: Unipolar voltage subtraction map guided PV isolation group

CT myocardial thickness map guided PV isolation group

EXPERIMENTAL

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: CT myocardial thickness map guided PV isolation group

Empirical PV isolation group

ACTIVE COMPARATOR

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.

Procedure: Empirical PV isolation group

Interventions

Unipolar voltage subtraction map guided PV isolation group 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.

Unipolar voltage subtraction map guided PV isolation group

CT myocardial thickness map guided PV isolation group 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.

CT myocardial thickness map guided PV isolation group

Empirical PV isolation group 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.

Empirical PV isolation group

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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
• Patients with active internal bleeding
• Patients with contraindications for anticoagulation therapy(for prevention of cerebral infarction) and antiarrhythmic drugs
• Patients with valvular atrial fibrillation (mitral stenosis \>grade 2, mechanical valve, mitral valvuloplasty)
• Patients with a severe comorbid disease
• Expected survival \< 1 year
• Drug addicts or alcoholics
• Patients who cannot read the consent form (illiterates, foreigners, etc.)
• Other patients who are judged by the principal or sub-investigator to be ineligible for participation in this clinical study

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Severance Cardiovascular Hospital, Yonsei University Health System

Seoul, 120-752, South Korea

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2019
• First Posted: April 11, 2019
• Study Start: October 6, 2021
• Primary Completion: April 1, 2025
• Study Completion: April 1, 2025
• Last Updated: June 13, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)