Clinical equivalence study of two brands of polyester sutures (Trubond® and Ethibond) for fixation of the valvular prosthesis, in subjects undergoing aortic or mitral valve replacement

Phase 4

Completed

• Conditions: Health Condition 1: O- Medical and Surgical

• Registration Number: CTRI/2020/04/024608
• Lead Sponsor: Healthium Medtech Pvt Ltd formerly Sutures India Pvt Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 25 July 2023

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 88

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. To assess the event rate of paravalvular leakage in both the groups.Timepoint: within 26 weeks of index surgery

Secondary Outcome Measures

Name	Time	Method
1. To assess the event rate of major adverse events (including death, stroke, myocardial infarction and surgical reintervention) in two groups <br/ ><br>2. To evaluate tissue reaction, material problems and other adverse events among the two groups. <br/ ><br>3.To evaluate postoperative discomfort and overall subject satisfaction score in both the groups <br/ ><br>Timepoint: within 26 weeks of index surgery