Health Condition 1: O- Medical and Surgical
Conditions
Interventions
Intervention1: Trubond® braided polyester suture: Braided polyester suture of Healthium Medtech Private Limited, used for fixation of the valvular prosthesis, using interrupted suture technique, in s
Sponsors
Healthium Medtech Pvt Ltd formerly Sutures India Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Subjects aged >=18 or 2. Subjects eligible for implantation of aortic or mitral valve through open heart surgery 3. Subjects who have given written informed consent
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. To assess the event rate of paravalvular leakage in both the groups.Timepoint: within 26 weeks of index surgery | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To assess the event rate of major adverse events (including death, stroke, myocardial infarction and surgical reintervention) in two groups 2. To evaluate tissue reaction, material problems and other adverse events among the two groups. 3.To evaluate postoperative discomfort and overall subject satisfaction score in both the groups Timepoint: within 26 weeks of index surgery | — |
Countries
India
Contacts
Public ContactDr Ashok Kumar Moharana
Healthium Medtech Pvt.Ltd.
Outcome results
None listed