A Pivotal Study of TSB-002C for the Treatment of Paroxysmal Atrial Fibrillatio
- Conditions
- Paroxysmal atrial fibrillation
- Registration Number
- JPRN-UMIN000008439
- Lead Sponsor
- Toray Industries, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 111
Not provided
[Tentative Registration] (1) Subject has undergone previous LA ablation or surgical treatment for AF. (2) Subject is resistant or intolerant to all of pilsicainide, cibenzoline, propafenone, disopyramide, and flecainide. (3) Subject is in New York Heart Association (NYHA) Class III or IV. (4) Subject has a history of myocardial infarction (MI) or unstable angina within six months prior to enrollment. (5) Subject has a known history of severe ischemic heart disease or valvular disease. (6) Subject has left atrial appendage occlusion device. (7) Subject has severe pulmonary arterial hypertension. (8) Subject has an artificial heart valve. (9) Subject has a pacemaker and/or implantable cardiodefibrillator (ICD) and/or implantable loop recorder. (10) Subject has a history of cerebrovascular disease, including cerebral vascular accident (CVA) or transient ischemic attack (TIA) within six months prior to enrollment. (11) Subject has a known history of severe obstructive carotid artery disease. (12) Subject has an inferior vena cava (IVC) filter. (13) Subject has a known and unresolved deep vein thrombus (DVT). (14) Subject has significant renal failure. (15) Subject has a known history of a bleeding disorder related to hemophilia, leukemia, or lymphoma etc. (16) Subject cannot take any anticoagulant drug. (17) Subject has abnormal thyroid function and judged to be unsuitable for participation in the study by the investigator. (18) Subject has a documented allergy to iodine or iodine contrast media. (19)(20)(21)(22) -- (23) Subject has been judged to be unsuitable for participation in the study by the investigator for any other reason. [Formal Registration] (47) Subject has a left atrium > 50 mm. (48) Subject has a left ventricular ejection fraction (LVEF) < 35%. (49) Subject has a left atrial thrombus. (50) Subject has been judged to be unsuitable for participation in the study by the investigator for any other reason.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary Efficacy Endpoints Comparison of the rate of long-term success between clinical device arm and antiarrhythmic drug therapy arm. Safety Endpoints Adverse event Clinical device malfunction
- Secondary Outcome Measures
Name Time Method