A Pilot Study of TSB-002 for the Treatment of Atrial Fibrillatio

Not Applicable

• Conditions: Paroxysmal or persistent atrial fibrillation

• Registration Number: JPRN-UMIN000004409
• Lead Sponsor: Toray Industries, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-10-19
• Study Completion: 2012-03-01
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

Exclusion Criteria

left atrium >= 50 mm. amiodarone within six months. undergone previous LA ablation or surgical treatment for AF. LVEF< 35%. NYHA Class III or IV. history of MI or unstable angina. non-revascularized left main or >= 3-vessel coronary artery disease. severe mitral valve regurgitation or stenosis and is not an appropriate candidate for valvular intervention. left atrial thrombus. left atrial appendage occlusion device. severe obstructive carotid artery disease. hypertrophic cardiomyopathy with severe left ventricular outflow tract obstructions. severe pulmonary arterial hypertension. artificial heart valve. pacemaker and or ICD. history of cerebrovascular disease. severe aortic stenosis. IVC filter. DVT. significant renal failure. known history of a bleeding disorder. unable to take warfarin. abnormal thyroid function. allergy to iodine or iodine type of contrast media. active malignancy of any kind. pregnant or lactating. participated in another clinical research study within 3 months. judged to be unsuitable for participation.

Study & Design

• Study Type: Interventional
• Study Design: Not specified