None listed
Conditions
Interventions
Procedure/Surgery : 1. Forward-looking randomization (freezing balloon pulmonary vein isolation group vs. Frozen balloon pulmonary vein isolation and additional vestibular resection using frozen ballo
Sponsors
Yonsei University Health System, Severance Hospital
Eligibility
Sex/Gender
All
Inclusion 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 volume index = 38ml/m2 3. paroxysmal atrial fibrillation that is reccurrence 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy evaluation: Major cardiovascular event rate – death, myocardial infarction, coronary angioplasty, and re-hospitalization for arrhythmia and heart failure;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;Efficacy evaluation: clinical recurrence rate – Defined as atrial fibrillation or atrial tachycardia > 30 sec after 3 months within 1 year; based on the 2017 HRS/EHRA/ECAS/APHRS/SOAECE expert consensus, 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 | — |
Secondary
| Measure | Time frame |
|---|---|
| Comparison of procedure time, ablation time, and hospitalization period;Comparison of anti-arrhythmic drug or anticoagulation therapy related complication rate;Comparison of re-hospitalization rate and number of electrical cardioversion after the procedure | — |
Countries
Korea, Republic of
Contacts
Public ContactSuah Lee
Yonsei University Health System, Severance Hospital
Outcome results
None listed