NCT04433065进行中（未招募）不适用
The Early Feasibility Study of the Transcatheter Tricuspid Valve Replacement System Transfemoral System
Medtronic Cardiovascular47 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2020年10月20日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 150
- 试验地点
- 47
- 主要终点
- Rate of implant or delivery related serious adverse events
研究概览
简要总结
The objective of this early feasibility study is to gain early clinical insight into the performance of the Intrepid transcatheter tricuspid valve replacement (TTVR) system intended for transfemoral access to deliver a self-expanding bioprosthetic valve within the tricuspid valve.
详细描述
Multi-center, prospective, non-randomized, investigational, and pre-market.
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
- •Heart Team agrees that patient is deemed symptomatic despite medical therapy (including obligatory diuretic) and a candidate for bioprosthetic tricuspid valve replacement
- •Subject is at an intermediate or greater estimated risk of mortality with tricuspid valve surgery as determined by the local Heart Team
- •Subjects with severe symptomatic primary and / or secondary tricuspid regurgitation determined by the Echocardiography Core Lab assessment of a qualifying transthoracic echocardiogram (TTE) and transesophageal echocardiogram (TEE)
- •New York Heart Association (NYHA) Function Class II or greater
- •Subject anatomically suitable for the Intrepid TTVR delivery system including transfemoral access
- •Subject and the treating physician agree that the subject will return for all required post-procedure follow-up visits
- •Subject meets the legal minimum age to provide informed consent based on local regulatory requirements
排除标准
- •Estimated life expectancy of less than 24 months due to associated non-cardiac co-morbid conditions
- •Anatomic contraindications for Intrepid™ TTVR (e.g., annular dimensions)
- •Evidence of intracardiac mass, inferior vena cava, or femoral venous mass or thrombus
- •Implanted with venous stents (iliac and/or femoral) or inferior vena cava (IVC) filter or congenital abnormalities of the IVC that would preclude ability for transfemoral access of delivery system
- •Echocardiographic evidence of severe right ventricular dysfunction
- •Left ventricular ejection fraction (LVEF) <30 as measured by resting echocardiogram within 30 days of the Index Procedure
- •Need for emergent or urgent surgery
- •Untreated clinically significant coronary artery disease requiring revascularization
- •Carcinoid tricuspid regurgitation
研究组 & 干预措施
Primary Cohort
Experimental
Device: Intrepid TTVR System
干预措施: Intrepid™ TTVR System (Device)
结局指标
主要结局
Rate of implant or delivery related serious adverse events
时间窗: Through 30 days post-procedure
Rate of implant or delivery related serious adverse events
次要结局
- Successful access, delivery of implant, and retrieval of the delivery system assessed by definitions per Mitral Valve Academic Research Consortium (MVARC)(During Procedure)
- Change in NYHA Class from baseline(Through 30 days post-procedure)
- Change in TR Grade from baseline(Through 30 days post-procedure)
- Rate of no significant TV stenosis(Through 30 days post-procedure)
研究者
研究点 (47)
Loading locations...
相似试验
招募中
不适用
Early Feasibility Study of the Cardiac Implants Percutaneous Ring Annuloplasty SystemTricuspid Regurgitation FunctionalNCT04890821Cardiac Implants LLC15
撤回
不适用
Early Feasibility Study of the CardiAQ™ TMVI System (Transfemoral and Transapical DS)Mitral InsufficiencyHeart Valve DiseaseHeart DiseaseCardiovascular DiseaseNCT02515539Edwards Lifesciences
招募中
不适用
EFS of the DUO System for Tricuspid RegurgitationTricuspid Valve InsufficiencyTricuspid Valve DiseaseHeart Valve DiseasesTricuspid RegurgitationNCT05913908CroiValve Limited15
已完成
不适用
Early Feasibility Study of Transcutaneous Upper Airway Stimulation in Obstructive Sleep ApneaObstructive Sleep ApneaOSANCT05881512Somnial Inc12
终止
不适用
Early Feasibility Study of the Percutaneous 4Tech TriCinch Coil Tricuspid Valve Repair SystemFunctional Tricuspid RegurgitationHeart Valve DiseasesTricuspid Valve InsufficiencyNCT036329674Tech Cardio Ltd.7