Contour 3D®/TriAd® Tricuspid Annuloplasty Ring Post-Market Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 64
- 试验地点
- 3
- 主要终点
- Change in the Degree of Tricuspid Regurgitation
研究概览
简要总结
The purpose of this study is to gather clinical information on the hemodynamic performance of the Contour 3D® and Tri-Ad® Tricuspid Annuloplasty Rings in a post-market environment.
详细描述
The primary goal of the TV repair procedure is to relieve patients from TV insufficiency or reduce TV stenosis. This study will evaluate the hemodynamic efficacy of the Contour 3D® and Tri-Ad® ring and characterize the effect of the TV repair through assessment of right atrial size and right ventricular function. Additionally, this study will characterize the patient population for whom a Contour 3D® or Tri-Ad® ring is chosen to repair TV insufficiency. Health status and adverse events (AE) will be assessed.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject or legal guardian willing and able to sign and date the Informed Consent Form (and Authorization to Use and Disclose Health Information Form, if applicable)
- •Subject indicated for a concomitant surgical repair of the TV
- •Subject is willing to return for required follow-up visits to the hospital where the implantation originally occurred
排除标准
- •Subject with a degenerative TV condition
- •Subject with primary TV regurgitation
- •Subject with a previous TV repair or replacement
- •Subject indicated for a stand-alone TV repair
- •Subject currently participating in an investigational drug or another device study
- •Subject with life expectancy of less than one year
- •Subject is pregnant or desires to be pregnant within 12 months following implantation
- •Subject is under 18 or over 85 years of age
- •Subject with active endocarditis
- •Subject with valvular retraction with severely reduced mobility
- •Subject with a heavily calcified TV
结局指标
主要结局
Change in the Degree of Tricuspid Regurgitation
时间窗: Preimplant through 12 Months
The primary objective is the evaluation of hemodynamic performance of the TV postimplant of a tricuspid annuloplasty ring in a postmarket environment. Degree of TV regurgitation - Change in the degree of tricuspid regurgitation from preimplant through 12 months postimplant.
The Mean Gradient Across the Tricuspid Valve
时间窗: 12 months
The primary objective is the evaluation of hemodynamic performance of the TV postimplant of a tricuspid annuloplasty ring in a postmarket environment by analysis of the mean gradient across the tricuspid valve. The mean gradient across the tricuspid valve measured at discharge, 6 months, and 12 months post-implant
Change in the Degree of TV Leaflet Coaptation Length
时间窗: Preimplant through 12 Months
The primary objective is the evaluation of hemodynamic performance of the TV postimplant of a tricuspid annuloplasty ring in a postmarket environment by analysis of the TV leaflet coaptation length. Change in the degree of TV leaflet coaptation length from preimplant through 12 months postimplant.
Change in the Degree of TV Leaflet Tethering Height
时间窗: Preimplant through 12 Months
The primary objective is the evaluation of hemodynamic performance of the TV postimplant of a tricuspid annuloplasty ring in a postmarket environment by analysis of the TV leaflet tethering height. Change in the degree of TV leaflet tethering height from pre-implant through 12 months post-implant
次要结局
- Demographic Data(Baseline)
- Change in the RV Fractional Area(Preimplant through 12 Months)
- Change in the Tricuspid Annular (Basal) Diameter(Preimplant through 12 Months)
- Change in New York Heart Association (NYHA) Classification .(Preimplant through 12 months)
- Change in the Right Ventricle (RV) Diastolic Area(Preimplant through 12 Months)
- Change in New York Heart Association (NYHA) Classification(Preimplant through 6 months)