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)
NCT number | NCT03912324 |
Other study ID # | 4-2019-0109 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | October 6, 2021 |
Est. completion date | April 2025 |
Verified date | June 2024 |
Source | Yonsei University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Severance Cardiovascular Hospital, Yonsei University Health System | Seoul |
Lead Sponsor | Collaborator |
---|---|
Yonsei University |
Korea, Republic of,
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 |
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