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
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 88
- 试验地点
- 2
- 主要终点
- 1. To assess the event rate of paravalvular leakage in both the groups.
研究概览
简要总结
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 1–5% 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Permuted block randomization, variable
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Subjects aged ≥18 or < 70 years
- •Subjects eligible for implantation of aortic or mitral valve through open heart surgery
- •Subjects who have given written informed consent.
排除标准
- •Subjects requiring multi-valve surgery
- •Subjects with a history of CABG or any valve surgery
- •Pregnancy and women of childbearing potential having positive urine pregnancy test prior to enrollment
- •Subjects with implanted pacemaker
- •Subjects with implantable cardiac defibrillator
- •Subjects with history of allergy to polyester or similar products
- •Subjects already participating in another surgical study
- •Subjects with history of bleeding disorders
- •Subjects who had the habit of drug abuse
- •Subjects who received an experimental drug or used an experimental medical device within 30 days prior to the planned start of procedure
- •Subjects unlikely to comply with surgical procedure or complete the scheduled follow up visit, in the opinion of investigator
- •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
- •Subjects with mental disorder, learning disability, or language barrier 14.
结局指标
主要结局
1. To assess the event rate of paravalvular leakage in both the groups.
时间窗: within 26 weeks of index surgery
次要结局
- 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.)