Paroxysmal atrial fibrillation
Conditions
Interventions
Ablation using TSB-002C
Antiarrhythmic drug therapy
Sponsors
Toray Industries, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: [Tentative registration] (1) Subject is >=20 and <75 years old. (2) Subject has been diagnosed with symptomatic paroxysmal AF. (3) Subject has failed to respond to or is intolerant of at least one Class I, II, III orIV AAD. ("Intolerant" is defined as having suffered a clinically significant adverse drug effect. (4) Subject is able and willing to provide informed consent. [Formal Registration] (5) Subject has at least two AF episodes in the 6 months preceding informed consent. (6) Subject has at least one documented AF episode via ECG, event monitor, or holter monitor in the 6 months proceding informed consent.
Exclusion criteria
Exclusion criteria: [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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Japan
Contacts
Public ContactJun Miyakawa
Toray Industries, Inc. Medical Devices Clinical Research Dept.
Outcome results
None listed