Cryoballoon pulmonary vein isolation vs. Cryoballoon pulmonary vein isolation with additional right atrial linear ablation for persistent atrial fibrillation: Prospective randomized trial (CRARAL Trial)
- Conditions
- Diseases of the circulatory system
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 330
1. Patient with persistent atrial fibrillation (sustained beyond 7 days) who is scheduled for ablation procedure and =20 and =80 years of age
2. Left atrium size < 45mm
3. persistent 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)
1. Patients with paroxysmal 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
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 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;Efficacy evaluation: Major cardiovascular event rate – death, myocardial infarction, coronary angioplasty, and re-hospitalization for arrhythmia and heart failure
- Secondary Outcome Measures
Name Time Method 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