Single blind, randomized study evaluating clinical equivalence of TrubondÂ® vs EthibondÂ® braided polyester suture for fixation of the valvular prosthesis, using interrupted suture technique, in subjects undergoing aortic or mitral valve replacement

Healthium Medtech Pvt Ltd formerly Sutures India Pvt Ltd0 个研究点目标入组 88 人开始时间: 待定最近更新: 2023年7月25日

试验速览

暂无简介。

•1. Subjects aged >=18 or < 70 years
•2. Subjects eligible for implantation of aortic or mitral valve through open heart surgery
•3. Subjects who have given written informed consent

•1. Subjects requiring multi-valve surgery
•2. Subjects with a history of CABG or any valve surgery
•3. Pregnancy and women of childbearing potential having positive urine pregnancy test prior to enrollment
•4. Subjects with implanted pacemaker
•5. Subjects with implantable cardiac defibrillator
•6. Subjects with history of allergy to polyester or similar products
•7. Subjects already participating in another surgical study
•8. Subjects with history of bleeding disorders
•9. Subjects who had the habit of drug abuse
•10. Subjects who received an experimental drug or used an experimental medical device within 30 days prior to the planned start of procedure
•11. Subjects unlikely to comply with surgical procedure or complete the scheduled follow up visit, in the opinion of investigator
•12. Employees of the investigator or study center with direct involvement in the proposed study or other studies under the direction of that investigator or study center
•13. Subjects with mental disorder, learning disability, or language barrier
•14. Other indication-based exclusion, in opinion of investigator

发起方

Healthium Medtech Pvt Ltd formerly Sutures India Pvt Ltd