NCT03904147进行中（未招募）不适用
Clinical Trial to Evaluate Cardiovascular Outcomes In Patients Treated With the Tricuspid Valve Repair System Pivotal
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 572
- 试验地点
- 150
- 主要终点
- For Randomized Cohort: Hierarchical Composite of All-cause Death or Tricuspid Valve Surgery, Heart Failure Hospitalizations, and KCCQ Improvement
研究概览
简要总结
The primary objective of this trial is to demonstrate the safety and effectiveness of the TriClip device in improving clinical outcomes in symptomatic patients with severe tricuspid regurgitation (TR), who are at intermediate or greater estimated risk for mortality or morbidity with tricuspid valve surgery. This randomized controlled trial will compare the investigational device (TriClip device) to Control (Medical Therapy).
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
- •In the judgment of the site local heart team, subject has been adequately treated per applicable standards (including medical management) and stable for at least 30 days as follows:
- •Optimized medical therapy for treatment of TR (e.g. diuretics).
- •Medical and/or device therapy, for mitral regurgitation, atrial fibrillation, coronary artery disease and heart failure.
- •The Eligibility Committee will confirm that the subject has been adequately treated medically.
- •Subject is symptomatic with Severe TR despite being optimally treated as described above. TR severity is determined by the assessment of a qualifying TTE and confirmed by the ECL. The ECL will also request a TEE to confirm TR etiology. Note: If any cardiac procedure(s) occur after eligibility was determined, TR severity will need to be re-assessed 30 days after the cardiac procedure(s).
- •The cardiac surgeon of the site local heart team concur that the patient is at intermediate or greater estimated risk for mortality or morbidity with tricuspid valve surgery.
- •New York Heart Association (NYHA) Functional Class II, III or ambulatory class IV
- •In the judgment of the TriClip(TM) implanting Investigator, femoral vein access is determined to be feasible and can accommodate a 25 Fr catheter.
- •Age ≥18 years at time of consent.
- •Subject must provide written informed consent prior to any trial related procedure.
排除标准
- •Systolic pulmonary artery pressure (sPAP) > 70 mmHg or fixed pre-capillary pulmonary hypertension as assessed by right heart catheterization (RHC)
- •Severe uncontrolled hypertension Systolic Blood Pressure (SBP) ≥ 180 mmHg and/or Diastolic Blood Pressure (DBP) ≥ 110 mm Hg
- •Any prior tricuspid valve procedure that would interfere with placement of the TriClip(TM) device
- •Indication for left-sided (e.g. severe aortic stenosis, severe mitral regurgitation) or pulmonary valve correction prior 60 days. Note: Patients with concomitant Mitral and tricuspid valve disease will have the option of getting their MR treated, and wait 60 days prior to being reassessed for the trial.
- •Pacemaker or ICD leads that would prevent appropriate placement of the TriClip(TM) clip.
- •Tricuspid valve stenosis - Defined as a tricuspid valve orifice of ≤ 1.0 cm2 and/or mean gradient ≥5 mmHg as measured by the ECL
- •Left Ventricular Ejection Fraction (LVEF) ≤20%
- •Tricuspid valve leaflet anatomy which may preclude clip implantation, proper clip positioning on the leaflets or sufficient reduction in TR. This may include:
- •Evidence of calcification in the grasping area
- •Presence of a severe coaptation defect (> 2cm) of the tricuspid leaflets
- •Severe leaflet defect(s) preventing proper device placement
- •Ebstein Anomaly - Identified by having a normal annulus position while the valve leaflets are attached to the walls and septum of the right ventricle.
- •Tricuspid valve anatomy not evaluable by TTE and TEE
- •Active endocarditis or active rheumatic heart disease or leaflets degenerated from rheumatic disease (i.e. noncompliant, perforated).
- •MI or known unstable angina within prior 30 days
- •Percutaneous coronary intervention within prior 30 days
- •Hemodynamic instability defined as systolic pressure < 90 mmHg with or without afterload reduction, cardiogenic shock or the need for inotropic support or intra-aortic balloon pump or other hemodynamic support device.
- •Cerebrovascular Accident (CVA) within prior 90 days
- •Chronic dialysis
- •Bleeding disorders or hypercoagulable state
- •Active peptic ulcer or active gastrointestinal (GI) bleeding
- •Contraindication, allergy or hypersensitivity to dual antiplatelet and anticoagulant therapy.
- •Note: Contraindication to either antiplatelet or anticoagulant therapy (individually not both therapies) is not an exclusion criterion.
- •Ongoing infection requiring current antibiotic therapy (if temporary illness, patients may enroll 30 days after discontinuation of antibiotics with no active infection).
- •Known allergy or hypersensitivity to device materials
- •Evidence of intracardiac, inferior vena cava (IVC), or femoral venous mass, thrombus or vegetation.
- •Life expectancy of less than 12 months
- •Subject is currently participating in another clinical trial that has not yet completed its primary endpoint.
- •Subject is currently participating in another clinical investigation for valvular heart disease(s).
- •Pregnant or nursing subjects and those who plan pregnancy during the clinical investigation follow-up period. Female subjects of child-bearing potential are required to have a negative pregnancy test done within 7 days of the baseline visit per site standard test. Female patients of childbearing potential should be instructed to use safe contraception (e.g., intrauterine devices, hormonal contraceptives: contraceptive pills, implants, transdermal patches hormonal vaginal devices, injections with prolonged release.) It is accepted, in certain cases, to include subjects having a sterilized regular partner or subjects using a double barrier contraceptive method.
- •Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results.
结局指标
主要结局
For Randomized Cohort: Hierarchical Composite of All-cause Death or Tricuspid Valve Surgery, Heart Failure Hospitalizations, and KCCQ Improvement
时间窗: 12 Months
Analysis of hierarchical composite of all-cause death or tricuspid valve surgery, heart failure hospitalizations, and KCCQ improvement of at least 15 points was performed in ITT population using Finkelstein-Schoenfeld method. A win ratio was also calculated to descriptively quantify the magnitude of treatment benefits. The win ratio is calculated as the ratio of the number of wins in Device versus Control patients. The primary analysis population consisted of 175 Device patients and 175 Control patients, resulting in 30,625 Device-Control patient pairs (i.e., 175 × 175).
For Single-Arm Cohort: Rate of Survival Through 12 Months With a Quality of Life Improvement (Assessed Using KCCQ Overall Score) of at Least 10 Points Compared to Baseline.
时间窗: 12 months
This outcome will be assessed as the percentage of subjects meeting the definition of the endpoint.
次要结局
- For Single-Arm Cohort: The Percentage of Subjects With TR Reduction by at Least 1 Grade at 30-Day Follow-up(30 days)
- For Randomized Cohort: Change in Quality of Life as Assessed by KCCQ Score(12 months minus baseline)
- For Randomized Cohort - Device Group Only: Rate of Kaplan-Meier Estimate (SE) of Freedom From Major Adverse Events (MAE) Occurring Within 30 Days Post-procedure(30 Days)
- For Randomized Cohort: Tricuspid Regurgitation Reduction to Moderate or Less at 30-Day Visit(30 Days)
- Recurrent HF Hospitalizations at 24 Months(24 months)
- Freedom From All-cause Mortality, Tricuspid Valve Surgery, and Tricuspid Valve Intervention at 24 Months(24 months)
- For Randomized Cohort: Change in 6 Minute Walk Test (6MWT) From Baseline to 12 Months(12 Months)
- For Single-Arm Cohort: Rate of Freedom From MAE Through 30 Days(30 days)
- For Single-Arm Cohort: Change in 6 Minute Walk Test (6MWT) From Baseline to 12 Months(12 months)
研究者
研究点 (150)
Loading locations...
相似试验
已完成
不适用
An Observational, Prospective Evaluation of the Trifecta™ ValveAortic Valve InsufficiencyRegurgitation, Aortic ValveAortic Valve IncompetenceAortic Valve StenosisNCT00727181Abbott Medical Devices120
招募中
不适用
Clinical Trial to Estimate the Efficacy of the Trapezium-Metacarpal (TMC) Prosthesis Compared to Suspensionplasty.First CarpoMetacarpal OsteoartrithisBasal Thumb OsteoartrithisNCT04562753Fundació d'investigació Sanitària de les Illes Balears106
已完成
不适用
AMBULATE: Cardiva Mid-Bore VVCS vs. Manual Compression for Multiple Femoral Venous Access Sites, 6 - 12F IDSurgical WoundNCT03193021Cardiva Medical, Inc.204
已完成
不适用
Evaluate Safety and Effectiveness of XenoSure Biological Patch in the Application of Cardiac RepairHeart DiseasesNCT03176225LeMaitre Vascular142
已完成
3 期
Efficacy and Safety of Botulinum Toxin Type A Haemagglutinin Complex Next Generation (BTX-A-HAC NG) in Glabellar LinesGlabellar LinesNCT02493946Ipsen600