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

Phase 4

Completed

Conditions: Medical and Surgical,

Registration Number: CTRI/2020/04/024608

Lead Sponsor: Healthium Medtech Pvt Ltd formerly Sutures India Pvt Ltd

Brief Summary: Valvular heart disease(VHD) is characterized by damage to or a congenital defect in one or more heartvalves: mitral, aortic, tricuspid, and pulmonary. Heart valves have a singlefunction: to permit unobstructed forward blood flow through the heart. Damagedor defective valves can cause two types of problems: either they fail to openproperly (a condition called stenosis) impeding blood flow, or they leak (acondition called regurgitation) permitting back flow. There are no effectivelong-term medical therapies for severe VHD.

Valve replacement orrepair performed either surgically or by catheter intervention are theonly effective therapies.

As a routine practice,polyester suture material is used to fix the valves. After the valvereplacement one of the problem which can occur is paravalvular leak. The causes include fibrosis or calcification of theannulus which fails to hold the sutures, rarely infections, improper suturingand undue stress on the suture lines.

Immediate post-operativestudies have identified minute suture leaks in 20% and hemodynamicallysignificant leaks only in 1â€“5% of subjects.

In this study we planto compare two commonly used brandsof braided polyester suturesfor fixation of the valvular prosthesis.

This study is designed tocompare clinical equivalence of Trubond (Healthium) and Ethibond (Johnson& Johnson) braided polyester suture for fixation of the valvularprosthesis, using interrupted suture technique, in subjects undergoing Aorticor mitral valve replacement.

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 88

Inclusion Criteria

Subjects aged â‰¥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

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.

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.	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	2. To evaluate tissue reaction, material problems and other adverse events among the two groups.

Trial Locations

Locations (2): Sri Jayadeva Institute of Cardiovascular Sciences & Research
🇮🇳
Bangalore, KARNATAKA, India
Sri Sathya Sai Institute of Higher Medical Sciences
🇮🇳
Anantapur, ANDHRA PRADESH, India
Sri Jayadeva Institute of Cardiovascular Sciences & Research
🇮🇳Bangalore, KARNATAKA, India
Dr PS Seetharama Bhat
Principal investigator
9448046534
pssbhat@gmail.com