NCT03632967终止不适用
Early Feasibility Study of the Percutaneous 4Tech TriCinch Coil Tricuspid Valve Repair System
4Tech Cardio Ltd.17 个研究点 分布在 1 个国家目标入组 7 人开始时间: 2018年9月12日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 7
- 试验地点
- 17
- 主要终点
- All-cause mortality of the Per Protocol cohort at 30 days post procedure.
研究概览
简要总结
The primary objective of the study is to generate feasibility safety and performance data for the 4Tech TriCinch Coil System in symptomatic patients suffering from moderate to severe functional tricuspid regurgitation with annular dilatation.
The TriCinch Coil System is a percutaneous catheter-based medical device for tricuspid valve repair.
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
- •Moderate to severe functional tricuspid regurgitation (TR) defined as: TR severity 2+ to 4+ (according to semi-quantitative echocardiographic color flow doppler evaluation); and Annular diameter ≥ 40 mm confirmed by echocardiography
- •Major of age( ≥ 18 years old or older per local regulation)
- •Subject has read and signed the informed consent prior to study related procedures.
- •Willing and able to comply with all required follow-up evaluations and assessments.
- •The 'Heart Team' assessment recommends TriCinch Coil Implantation
- •New York Heart Associate Classification ≥ II.
- •Left Ventricular Ejection Fraction ≥ 30%.
- •Heart failure symptoms (such as fluid retention and severe oedema, liver stasis) despite on optimized medical therapy by the local heart team; at minimum subject on diuretic use
- •Subject has suitable anatomy for investigational device implantation as per imaging requirements
排除标准
- •Currently participating in another investigational drug or device study.
- •Subject with Systolic pulmonary arterial pressure (sPAP) > 60mmHg as measured by Transthoracic Echocardiography (TTE)
- •Subject requiring another cardiac procedure in the framework of the index procedure; subject requiring a percutaneous procedure within 30 days before or after the procedure or a cardiac surgical procedure within 3 months before or after the procedure
- •Moderate or Severe tricuspid valve stenosis (defined as a mean gradient ≥5 mmHg at normal heart rate)
- •Aortic and/or pulmonic valve stenosis and/or regurgitation more than or equal to moderate
- •Mitral stenosis and/or regurgitation more than moderate
- •Intra-cardiac thrombus, mass or vegetation requiring active treatment.
- •Implanted inferior vena cava (IVC) filter.
- •Prior tricuspid repair or tricuspid replacement
- •Known allergy to contrast media, silicone, PET, Co-Cr, stainless steel or nitinol that cannot be adequately pre-medicated
- •History of cardiac transplantation
- •Contraindication to Transthoracic/Transoesophageal Echocardiography (TTE/TOE).
- •Endocarditis or severe infection within 12 months of scheduled implant procedure
- •Myocardial Infarction (MI) or known unstable angina within the 30 days prior to the index procedure
- •Cerebro Vascular Accident within the previous 6 months
- •Hemodynamic instability or on IV inotropes
- •Contraindication to anticoagulant therapy and antiplatelet therapy
- •Bleeding disorders or hypercoagulable condition (at risk of blood clots
- •Active peptic ulcer or active GI bleeding within 3 months of scheduled implant procedure
- •Severe renal impairment or on dialysis
- •Life expectancy less than 12 months.
- •Acute anemia
- •Chronic Oral Steroid Use ≥ 6 months
- •Pregnant or lactating female of childbearing potential with a positive pregnancy test 24 hours before any study-related radiation exposure
- •Pulmonary embolism within the last 6 months
- •Tricuspid Valve Tethering distance > 10 mm
- •Presence of trans-tricuspid pacemaker or defibrillator leads which are determined as immobile or interfering with the procedure, as evaluated by echocardiography.
- •Contra-indicated for blood transfusion or refuses transfusion
- •Patient undergoing emergency treatment
- •Patient without appropriate venous access
结局指标
主要结局
All-cause mortality of the Per Protocol cohort at 30 days post procedure.
时间窗: 30 days post procedure
次要结局
- Number of individual adverse events related to the system or procedure.(30 days, three (3), six (6), twelve (12) and twenty-four (24) months post procedure)
- Echocardiographic changes in Effective Regurgitant Orifice Area (EROA) compared to Baseline(30 days, three (3), six (6), twelve (12) and twenty-four (24) months post procedure)
- Functional changes as compared to Baseline for New York Heart Association (NYHA) classification(30 days, three (3), six (6), twelve (12) and twenty-four (24) months post procedure)
- Quality of Life evaluation using the Kansas City Cardiomyopathy Questionnaire (KCCQ).(30 days, three (3), six (6), twelve (12) and twenty-four (24) months post procedure)
- Rate of Heart Failure event post-procedure defined as a heart failure hospitalization or a heart failure hospitalization equivalent(30 days, three (3), six (6), twelve (12) and twenty-four (24) months post procedure)
- Exercise tolerance (Six Minute Walk Test)(30 days, three (3), six (6), twelve (12) and twenty-four (24) months post procedure)
研究者
研究点 (17)
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