TRIal to Evaluate TraNsvenous TrIcuspid Valve ReplacemenT With LuX-Valve Plus System in Patients With Severe or Greater Tricuspid Regurgitation - SafetY and Clinical Performance
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 15
- 试验地点
- 6
- 主要终点
- Primary Outcome - Incidence of major adverse events at 30 days post procedure
研究概览
简要总结
The LuX-Valve Plus System is intended for the treatment of patients with at least severe TR who are symptomatic and determined by a Heart Team not to be suitable for surgical treatment. This study aims to assess the safety and effectiveness of the LuX-Valve Plus System in high-surgical risk patients with at least severe tricuspid regurgitation (TR).
详细描述
Investigational Device:
The LuX-Valve Plus System consists of the following elements:
- a bioprosthetic valve consistent of bovine pericardial tissue mounted on a self-expanding nitinol stent frame (hereafter referred to as LuX-Valve Implant).The LuX-Valve Implant consists of a trileaflet bovine-pericardial-tissue valve, a nitinol self-expanding stent, a fabric skirt, a pair of clips, an anchoring pin and sutures.
- a catheter-based delivery system (hereafter referred to as LuX-Valve Delivery Device),
- an Introducer Kit for transvenous access, and
- a delivery system Stabilizer.
- The LuX-Valve Implant sizes:
o JS/TTVI-28-40, JS/TTVI-28-45, JS/TTVI-28-50, JS/TTVI- 28-55, JS/TTVI-30-40, JS/TTVI-30-45, JS/TTVI-30-50, JS/TTVI-30-55, JS/ TTVI-30-60, JS/TTVI-30-65
- LuX--Valve Plus Delivery 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
- •Age ≥18 years at time of consent
- •Severe or greater TR assessed on transthoracic echocardiography by Echocardiography Core Lab using a 5-grade classification (Mild, Moderate, Severe, Massive, Torrential).
- •New York Heart Association (NYHA) Class II-IV
- •The Patient is being treated on optimal dosage for diuretics at investigator discretion
- •The Site Heart Team concur the patient is not an optimal candidate for surgical treatment and it is anatomically suitable for transcatheter tricuspid valve replacement
- •Patient must be able to fully understand all aspects of the investigation that are relevant to the decision to participate and provide a written informed consent
- •Anatomical inclusion criteria confirmed by echocardiographic core lab, CT core lab and Eligibility Committee
排除标准
- •Left Ventricular Ejection Fraction (LVEF) <35%
- •Pulmonary arterial systolic pressure (PASP) >60 mmHg by echo Doppler (unless right heart catheterization [RHC] demonstrates PASP ≤60mmHg); or Right heart catheterization OR PASP >2/3 systemic BP with PVR >5 Wood units after vasodilator challenge, in the absence of symptomatic hypotension or systolic BP <90 mmHg.
- •Evidence of intracardiac mass, thrombus, or vegetation
- •Ebstein Anomaly or congenital right ventricular dysplasia
- •Surgical correction is indicated for other concomitant valvular disease (subjects with concomitant valvular disease may treat their respective valve first and wait 2 months before being reassessed for the trial)
- •Patients with valve prostheses implanted in the tricuspid valve
- •Pre-existing prosthetic valve(s) (other than tricuspid ones) with clinically significant prosthetic dysfunction
- •Active infection, infective endocarditis or sepsis within 3 months, or infections requiring antibiotics treatment within two weeks prior to planned procedure
- •Untreated clinically significant coronary artery disease requiring revascularization
- •Acute myocardial infarction or unstable ischemia-related angina within 30 days prior to the planned procedure
- •Any percutaneous coronary, intracardiac or carotid intervention within 30 days prior to the planned procedure
- •Any coronary or intracardiac or carotid intervention within 30 days prior to the planned procedure
- •Cardiogenic shock manifested by low cardiac output, vasopressor dependence, or mechanical hemodynamic support TRINITY-US Trial #: Ver 1.0, 14 Nov 2023, Confidential Page 7 of 8
- •Cerebrovascular stroke (ischemic or bleeding) within prior 3 months to enrollment
- •Active peptic ulcer or active gastrointestinal bleeding within prior 3 months to enrollment
- •Blood dyscrasias as defined: leukopenia (WBC <1000 mm3), thrombocytopenia (platelet count <50,000 cells/mm3), history of bleeding diathesis, or coagulopathy
- •Inability to tolerate anticoagulation or antiplatelet therapy
- •Severe liver failure
- •Renal insufficiency (eGFR <30 mL/min [per the Cockcroft-Gault formula] and/or renal replacement therapy)
- •Uncontrolled atrial fibrillation (e.g., resting heart rate >120 bpm)
- •Pregnancy or intent to become pregnant prior to completion of all protocol follow-up requirements
- •Severe Chronic Obstructive Pulmonary Disease requiring steroids or requiring continuous home oxygen
- •Untreatable hypersensitivity or contraindication to any of the following: all antiplatelets, all anticoagulants, nitinol alloys (nickel and titanium), bovine tissue, glutaraldehyde, or contrast media
- •Estimated life expectancy <12 months.
- •Subjects currently participating in another clinical trial of an investigational drug or device that has not yet completed its primary endpoint
- •Patients with current history of illicit drug use
- •Any other condition making it unlikely the patient will be able to complete all protocol procedure and follow-ups determined by the investigator
结局指标
主要结局
Primary Outcome - Incidence of major adverse events at 30 days post procedure
时间窗: at 30 days post procedure
A composite endpoint of Major Adverse Event (MAE) at 30 days post procedure, as listed below: * Cardiovascular Death * Myocardial Infarction (MI) * Stroke * New Onset Renal Failure Requiring Unplanned Dialysis or Hemofiltration * Major Bleeding (includes type 3b or higher as defined by Tricuspid Valve Academic Research Consortium \[TVARC\]) * Tricuspid Valve Surgery or Transcatheter Re-intervention post Procedure * Major Access Site and Vascular Complications * Major Cardiac Complications * Device-related Pulmonary Embolism * New Pacemaker Implantation due to Atrioventricular (AV) Block
Primary Outcome - Post-procedural TR Remission Rate
时间窗: at 30 days post procedure
Defined as: Post-procedural TR of moderate or less (TR≤2+) without clinically significant paravalvular leak (PVL) on a transthoracic echocardiography (TTE) at 30 days post- procedure (Assessed by the Echocardiography Core Lab using a 5-grade classification)
次要结局
- Acute Secondary Endpoints - Intraprocedural success Rate(the first 24h post-procedure)
- Acute Secondary Endpoints - Clinical success Rate(at 30 days and at 1 year post-procedure)