Transcatheter Tricuspid Valve Replacement Using the Medtronic Intrepid™ TTVR System in Patients With Severe Symptomatic Tricuspid Regurgitation - PATHFINDER
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,186
- 试验地点
- 4
- 主要终点
- Rate of Major Adverse Events (MAE)
研究概览
简要总结
This clinical trial evaluates the safety and effectiveness of the Medtronic Intrepid™ Transcatheter Tricuspid Valve Replacement (TTVR) System in symptomatic patients with severe or greater tricuspid regurgitation.
详细描述
Prospective, global, pre-market, interventional, multi-center, randomized controlled pivotal trial to evaluate the safety and effectiveness of the Medtronic Intrepid™ Transcatheter Tricuspid Valve Replacement (TTVR) System compared to Edwards EVOQUE TTVR System in symptomatic patients with severe or greater 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
- Single (Outcomes Assessor)
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
- •Age ≥18 years at the time of consent.
- •Severe symptomatic tricuspid regurgitation (TR) despite optimal medical therapy (OMT).
- •Local site multidisciplinary heart team experienced in tricuspid valve therapies agrees that the subject is appropriate for TTVR.
排除标准
- •Any tricuspid device currently in place.
- •Anatomic contraindications.
- •Need for emergent or urgent surgery.
- •Left ventricular ejection fraction <25%.
研究组 & 干预措施
Medtronic Intrepid™ TTVR
Transcatheter tricuspid valve replacement with Medtronic Intrepid™ TTVR System in patients with severe or greater tricuspid regurgitation.
干预措施: Medtronic Intrepid™ Transcatheter Tricuspid Valve Replacement (TTVR) System (Device)
Edwards EVOQUE TTVR
Transcatheter tricuspid valve replacement with Edwards EVOQUE TTVR in patients with severe or greater tricuspid regurgitation.
干预措施: Edwards EVOQUE Tricuspid Valve Replacement (TTVR) System (Device)
Single Arm Registry
Transcatheter tricuspid valve replacement with Medtronic Intrepid™ TTVR System in patients with severe or greater tricuspid regurgitation who are not eligible for randomization.
干预措施: Medtronic Intrepid™ Transcatheter Tricuspid Valve Replacement (TTVR) System (Device)
结局指标
主要结局
Rate of Major Adverse Events (MAE)
时间窗: 30-days post-procedure
Composite Endpoint: All-cause mortality, Heart failure hospitalization, and tricuspid valve reintervention
时间窗: 1-year post-procedure
次要结局
- Tricuspid regurgitation (TR) grade reduction(6 months post-procedure)
- Change in quality of life (QoL) as measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ) from baseline(6 months post-procedure)
- All-cause mortality(12 months post-procedure)
- Heart failure hospitalization(12 months post-procedure)
- New onset conduction disturbance (NOCD)(30 days post-procedure)
- Total procedure time(Procedure)
- Right ventricle (RV) dysfunction(12 months post-procedure)
- Tricuspid regurgitation (TR) grade reduction(6 months post-procedure)
- Change in quality of life (QoL) as measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ) from baseline(6 months post-procedure)
- All-cause mortality(12 months post-procedure)
- Heart failure hospitalization(12 months post-procedure)
- New onset conduction disturbance (NOCD)(30 days post-procedure)
- Total procedure time(Procedure)
- Right ventricle (RV) dysfunction(12 months post-procedure)