Edwards EVOQUE Transcatheter Tricuspid Valve Replacement: Real World European Investigation of Safety and Clinical Efficacy Using a Novel Device
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 500
- 试验地点
- 24
- 主要终点
- Number of patients with major adverse events (MAE rates)
研究概览
简要总结
This is a prospective, single-arm, multi-center, real-world study of an the Edwards EVOQUE system.
详细描述
This is a prospective, single-arm, multi-center, real-world study of an approved device. Up to 500 patients will be enrolled in this study at up to 45 sites in Europe. All enrolled patients will be assessed at the following intervals: baseline, index procedure, discharge (or 7-days post-index procedure whichever occurs first), 30 days, 1 year, and annually through 5 years.
Study enrollment is expected to last approximately 2-4 years, followed by 5 years of follow-up.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The Local Site Heart Team determines that the patient is appropriate for transcatheter tricuspid valve replacement with the EVOQUE system per the current instructions for use.
- •Patient agrees to attend follow-up assessments.
- •Patients provided written informed consent for participation in the study.
排除标准
- •Patient participating in another interventional biologic, drug, or device clinical study that has not met its primary endpoint(s).
- •Any patient considered to be part of a vulnerable population.
研究组 & 干预措施
Treatment
Treatment with the Edwards EVOQUE Tricuspid Transcatheter Valve Replacement System
干预措施: Transcatheter Tricuspid Valve Replacement (Device)
结局指标
主要结局
Number of patients with major adverse events (MAE rates)
时间窗: 30 days
The primary safety endpoint is the proportion of patients with major adverse events (MAEs) at 30 days
Tricuspid regurgitation grade
时间窗: Up to 7 days, 30 days, and 1 year
Number of patients with optimal TR grade (≤1 on a 0-5 grade scale)
次要结局
- Health Status - Assessed by Kansas City Cardiomyopathy Questionaire (KCCQ) Scores(30 days, 1 year, and 2 years)
- All-cause mortality(30 days, 1 year, and 2 years)
- Cardiovascular mortality(30 days, 1 year, and 2 years)
- Heart failure hospitalizations(30 days, 1 year, and 2 years)
- Tricuspid valve re-intervention(30 days, 1 year, and 2 years)
- NYHA Functional Class(30 days, 1 year, and 2 years)