J-BAF study Evaluation of the efficacy and safety of Bepridil hydrochloride in the conversion of persistent atrial fibrillation.A placebo-controlled, randomized, double-blind study.
- Conditions
- Persistent atrial fibrillation
- Registration Number
- JPRN-jRCT1091220005
- Lead Sponsor
- Bepridil central office
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
Persistent AF lasting 7 days or longer by electrocardiogram in term of the surveillance
1)Persistent AF lasting 1 year or longer.
2)Cardiac surgery, myocardial infarction within 1 month of the onset or unstable clinical manifestation.
3)AF because of underlying disease or complications as follows; sick sinus syndrome, giant left atrium, AF with disturbances of conduction, hyperthyrea, mitral stenosis.
4)left ventricular ejection fraction <= 40%, or heart failure level III orIV at New York Heart Association classification of cardiac performance.
5)Bradyasystolic AF.
6)marked QT increased.
7)a history of syncope because of polymorphic ventricular tachycardia or antiarrhythmic agent.
8)very low blood pressure
9)Contraindication for anticoagulation therapy
10)Severe liver and/or kidney dysfunction
11)a history of Bepridil
12)a history of administrated other CTM
13)females of known or suspected pregnancy
14)Patients disqualified participating this trial by Dr.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Rate of patients recognized sinus rhythm by electrocardiographic representation throughout clinical study
- Secondary Outcome Measures
Name Time Method Time to sinus rhythm, improvement rate of subjective symptom