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

Paroxysmal Atrial Fibrillation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03912324
• Other study ID #: 4-2019-0109
• Status: Recruiting
• Phase: N/A
• Start date: October 6, 2021
• Est. completion date: April 2025

Study information

• Verified date: June 2024
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 220
• Est. completion date: April 2025
• Est. primary completion date: April 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Paroxysmal Atrial Fibrillation

Intervention

Procedure:
• Unipolar voltage subtraction map guided PV isolation group
Pulmonary vein isolation will be performed using a radiofrequency catheter Esophageal temperature will be monitored to prevent esophageal injury Mapping of echocardiographic unipolar voltage subtraction after atrial septal puncture the electrode map data is transferred to the core lab by network to calculate the unipolar voltage subtraction color map (within 10 minutes) Increase radiofrequency ablation time by 2 to 5 seconds in areas with high potential in unipolar voltage subtraction color map Decrease radiofrequency ablation time by 2 to 5 seconds in areas with low potential in unipolar voltage subtraction color map Evaluation of success rate and time of pulmonary vein isolation after bilateral pulmonary vein primary columnar resection Evaluate time to complete isolation after additional ablation Evaluation of Procedure and Ablation time, and perfusion saline dose Rhythm follow-up after the procedure in accordance with the study design.
• CT myocardial thickness map guided PV isolation group
Pulmonary vein isolation will be performed using a radiofrequency catheter Esophageal temperature will be monitored to prevent esophageal injury. Prepared myocardial thickness map with CT DICOM images conducted prior to procedure. Increase radiofrequency ablation time by 2 to 5 seconds in thick areas in CT myocardial thickness map Decrease radiofrequency ablation time by 2 to 5 seconds in thin areas in CT myocardial thickness map Evaluation of success rate and time of pulmonary vein isolation after bilateral pulmonary vein primary columnar resection Evaluate time to complete isolation after additional ablation Evaluation of Procedure time, Ablation time, and perfusion saline dose Rhythm follow-up will be performed after the procedure in accordance with the aforementioned study design.
• Empirical PV isolation group
Pulmonary vein isolation will be performed using a radiofrequency catheter Esophageal temperature will be monitored to prevent esophageal injury. The procedure is performed by adjusting radiofrequency energy according to the traditional method and experience of the practitioner. Evaluation of success rate and time of pulmonary vein isolation after bilateral pulmonary vein primary columnar resection Evaluate time to complete isolation after additional ablation Evaluation of Procedure time, Ablation time, and perfusion saline dose Rhythm follow-up will be performed after the procedure in accordance with the aforementioned study design.

Locations

Country	Name	City	State
Korea, Republic of	Severance Cardiovascular Hospital, Yonsei University Health System	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Efficacy evaluation: Major cardiovascular event rate	death, myocardial infarction, coronary angioplasty, and re-hospitalization for arrhythmia and heart failure	immediate after procedure
Primary	Efficacy evaluation: Major cardiovascular event rate	death, myocardial infarction, coronary angioplasty, and re-hospitalization for arrhythmia and heart failure	12 months after procedure
Secondary	Comparison of procedure time		immediate after procedure
Secondary	Comparison of ablation time		immediate after procedure
Secondary	Comparison of hospitalization period		immediate after procedure
Secondary	Comparison of anti-arrhythmic drug or anticoagulation therapy related complication rate		1 week after procedure
Secondary	Comparison of anti-arrhythmic drug or anticoagulation therapy related complication rate		3 months after procedure
Secondary	Comparison of anti-arrhythmic drug or anticoagulation therapy related complication rate		6 months after procedure
Secondary	Comparison of anti-arrhythmic drug or anticoagulation therapy related complication rate		12 months after procedure
Secondary	Comparison of anti-arrhythmic drug or anticoagulation therapy related complication rate		18 months after procedure
Secondary	Comparison of anti-arrhythmic drug or anticoagulation therapy related complication rate		24 months after procedure
Secondary	Comparison of anti-arrhythmic drug or anticoagulation therapy related complication rate		36 months after procedure
Secondary	Comparison of re-hospitalization rate after the procedure		1 week after procedure
Secondary	Comparison of re-hospitalization rate after the procedure		3 months after procedure
Secondary	Comparison of re-hospitalization rate after the procedure		6 months after procedure
Secondary	Comparison of re-hospitalization rate after the procedure		12 months after procedure
Secondary	Comparison of re-hospitalization rate and number of electrical cardioversion after the procedure		18 months after procedure
Secondary	Comparison of re-hospitalization rate after the procedure		24 months after procedure
Secondary	Comparison of re-hospitalization rate after the procedure		36 months after procedure
Secondary	Comparison of number of electrical cardioversion after the procedure		1 week months after procedure
Secondary	Comparison of number of electrical cardioversion after the procedure		3 months after procedure
Secondary	Comparison of number of electrical cardioversion after the procedure		6 after procedure
Secondary	Comparison of number of electrical cardioversion after the procedure		12 months after procedure
Secondary	Comparison of number of electrical cardioversion after the procedure		18 months after procedure
Secondary	Comparison of number of electrical cardioversion after the procedure		24 months after procedure
Secondary	Comparison of number of electrical cardioversion after the procedure		36 months after procedure