Flexible Band Versus Rigid Ring Annuloplasty for the Correction of Tricuspid
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- A composite of reoperation for tricuspid regurgitation, progression of tricuspid regurgitation by two grades from baseline or the presence of severe tricuspid regurgitation, or death.
研究概览
简要总结
Tricuspid regurgitation is common in patients with heart valve disease, both flexible band and rigid ring annuloplasty can correct this anomaly. However, there is no data to address which one can bring more benefits to these patients with combined heart valve disease. This study aims to prospectively compare the efficacy and long term outcomes of flexible band versus rigid ring annuloplasty for the correction of tricuspid regurgitation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None (Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1. Subject must be 18 years and 70 years at time of consent and must not be a member of a vulnerable population.
- •2. Subject or a legally authorized representative (where allowed per local regulations) must provide written informed consent prior to any trial related procedure.
- •3. Subjects with tricuspid regurgitation determined by the assessment of a qualifying transthoracic echocardiogram (TTE) and/or transesophageal echocardiogram (TEE).
排除标准
- •1. Patient unable or unwilling to provide informed consent;
- •2. Subjects with mild tricuspid regurgitation;
- •3. Emergency surgery;
- •4. Prior tricuspid valve leaflet surgery or any currently implanted prosthetic tricuspid valve, or any prior transcatheter tricuspid valve procedure;
- •5. Subjects with percutaneous coronary intervention within prior 30 days prior to enrollment;
- •6. Subjects with presence of any known life threatening (non-cardiac major or progressive disease), non-cardiac disease that will limit the subject's life expectancy to less than one year;
- •7. Subjects with permanent or temporary pacemaker implantation;
- •8. Subjects with severe, irreversible pulmonary hypertension in the judgment of the investigator;
- •9. History of mitral/tricuspid endocarditis within the last 12 months;
- •10. Subjects with contraindication or known allergy to device's components, aspirin, anti-coagulation therapy or contrast media that cannot be adequately premeditated;
- •11. Subjects with bleeding or coagulation disorders (e.g. active peptic ulcer or active gastrointestinal bleeding);
- •12. Female patient is pregnant (urine HCG test result positive) or lactating;
- •13. Subject is currently participating in another clinical trial that has not yet completed its primary endpoint;
- •14. Subjects with left ventricular ejection fraction (LVEF)≤20%.
研究组 & 干预措施
Group Ring
Patients in Group Ring will undergo tricuspid rigid ring annuloplasty
干预措施: Tricuspid Annuloplasty (Procedure)
Group Band
Patients in Group Band will undergo flexible band annuloplasty
干预措施: Tricuspid Annuloplasty (Procedure)
结局指标
主要结局
A composite of reoperation for tricuspid regurgitation, progression of tricuspid regurgitation by two grades from baseline or the presence of severe tricuspid regurgitation, or death.
时间窗: at follow-up of 5 years
Improvement in tricuspid regurgitation: refers to Mild or No tricuspid regurgitation Tricuspid regurgitation is graded as mild, moderate, and severe based on regurgitant jet area
次要结局
- Mortality(up to 3 months of intervention)
研究者
Hong Liu
Staff of Department of Cardiothoracic Surgery
The First Affiliated Hospital with Nanjing Medical University