CTRI/2020/04/024608
Completed
Phase 4
Single blind, randomized study evaluating clinical equivalence of Trubond® vs Ethibond® 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 sites88 target enrollmentTBD
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Health Condition 1: O- Medical and Surgical
- Sponsor
- Healthium Medtech Pvt Ltd formerly Sutures India Pvt Ltd
- Enrollment
- 88
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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