NCT06611579招募中不适用
A Clinical Study of the inQB8 Transcatheter Tricuspid Valve Replacement System
inQB8 Medical Technologies, LLC14 个研究点 分布在 3 个国家目标入组 50 人开始时间: 2025年6月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 14
- 主要终点
- Absence of device or procedure related major adverse events
研究概览
简要总结
Prospective, multi-center study to assess safety and performance of the inQB8 MonarQ Tricuspid Valve Replacement System.
详细描述
The study is a multi-center, prospective, single-arm study to assess safety and performance of the inQB8 Medical Technologies MonarQ Tricuspid Valve Replacement System.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Anatomically suitable for the MonarQ TTVR System
- •Symptomatic, tricuspid regurgitation (TR) that is severe or greater
- •Adequately treated for heart failure based upon medical standards
- •Hemodynamically stable
排除标准
- •Need for emergent or urgent surgery for any reason, any planned cardiac surgery within the next 12 months (365 days), or any planned percutaneous cardiac procedure within the next 90 days
- •Refractory Heart Failure (HF) that requires or required advanced intervention
- •Any condition, in the opinion of the investigator, making it unlikely the patient will be able to complete all protocol procedures and follow-up.
- •Currently participating in another investigational biologic, drug or device study
研究组 & 干预措施
Treatment
Experimental
Treatment with the inQB8 MonarQ Transcatheter Tricuspid Valve Replacement System
干预措施: Transcatheter Tricuspid Valve Replacement (Device)
结局指标
主要结局
Absence of device or procedure related major adverse events
时间窗: 30 days
Change in TR grade from baseline
时间窗: 30 days
次要结局
- Device and procedure related complications(30 days and 12 months)
- NYHA functional classification(30 days, 6 months, 1 year, and through study completion, an average of 1 year)
- Six-minute-walk test(30 days, 6 months, 1 year, and through study completion, an average of 1 year)
- Health status - KCCQ(30 days, 6 months, 1 year, and through study completion, an average of 1 year)
- TR grade(30 days, 6 months, 1 year, and through study completion, an average of 1 year)
- Hospitalization(30 days, 6 months, 1 year, and through study completion, an average of 1 year)
研究者
研究点 (14)
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