NCT07517588招募中不适用
Early Feasibility Experience of Posterior Leaflet Replacement to Reduce Mitral Regurgitation Using the MRace Implant (United States)
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 15
- 试验地点
- 3
- 主要终点
- Primary Performance Endpoint
研究概览
简要总结
The goal of this early feasibility clinical trial is to learn if the device MR-ace Implant and Delivery System works in patients with moderate or severe mitral valve regurgitation. It will also learn about the safety of the device MR-ace Implant and Delivery System. The main questions it aims to answer are:
Does implanting the MR-ace device reduce the symptoms of mitral regurgitation? Does the device reduce the the leak through your mitral valve?
Participants will:
Be implanted with the device Visit the clinic for checkups and tests at 30 days, 6 months, 12 months, and 2, 3, 4 and 5 years following your procedure Complete a quality of life survey
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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient has symptomatic moderate-to-severe to severe functional mitral regurgitation despite stable doses of maximally tolerated guideline directed medical therapy (GDMT) per the Local Heart Team.
- •Note: In the 30 days prior to performing screening assessments, no new GDMT medications should be introduced and current doses should be stable (i.e. no decrease of > 50% or increase of > 100%) excluding diuretics. Any changes beyond this range would not be considered stable GDMT.
- •Functional MR graded 3+ or higher (using a scale of 0 to 4+) by transthoracic echocardiography (TTE) within 60 days prior to study procedure as evaluated by the sponsor's Echo Core Lab.
- •New York Heart Association (NYHA) Functional Class II, III or ambulatory IV heart failure
- •Patient must present with an STS Score less than 10% and deemed by the Local Heart Team to be at high risk but operable for mitral valve surgery.
- •The Local Heart Team deems the patient unsuitable for commercially approved transcatheter mitral valve therapies
- •21 years of age or older
- •Native mitral valve geometry and size is compatible with the Polares MRace system
- •Anatomy is suitable for transfemoral transseptal access with the Polares MRace system
- •Patient is willing to participate in study and provides signed IRB/EC-approved informed consent
- •Treating physician and patient agree that patient is able to return for all required post-procedure follow-up visits
- •Patient is approved by an independent Patient Eligibility Committee
排除标准
- •Echocardiographic parameters (any of the following, assessed by the Echo Core Lab)
- •Left ventricular ejection fraction (LVEF) < 30%
- •Pulmonary artery systolic pressure (PASP) > 70mmHg or > 2/3 SBP (Systolic Blood Pressure)
- •Left Ventricle End Diastolic Volume (LV EDV) > 200 mL
- •Left Ventricle End Systolic Volume (LV ESV) > 140 mL
- •Left Ventricle End Diastolic Diameter (LV EDD) > 70 mm
- •Left Ventricle End Systolic Diameter (LV ESD) > 55 mm
- •Severe Right Ventricle (RV) dysfunction as per assessment by Local Heart Team or Eligibility Committee .
- •Severe tricuspid regurgitation.
- •Severe aortic stenosis or insufficiency.
- •Severe mitral annulus calcification.
- •Diseased mitral anterior and/or posterior leaflet, such as flail, / prolapse, or/ heavy moderate to severe calcification.
- •Barlow's disease.
- •Presence of an implanted vena cava filter or any other device (e.g. ASD closure device) that may interfere with femoral vein access or delivery system access to the mitral valve.
- •Contraindication for transesophageal echocardiography (TEE) or MDCT scan
- •Active infection or endocarditis or infection requiring antibiotic therapy within 2 weeks of scheduled procedure.
- •Previous mitral valve surgery or transcatheter mitral valve procedure.
- •Prior orthotopic heart transplantation.
- •Evidence of intra-cardiac, inferior vena cava (IVC) or femoral venous thrombus. History of deep vein thrombosis (DVT) or pulmonary embolism within 6 months of the index procedure.
- •Untreated Class I indication for pacing (CRT). Implant or revision of any pacing device < 30 days prior to intervention
- •Any untreated clinically significant coronary artery disease requiring revascularization. Coronary, carotid, or endovascular artery disease treated percutaneously < 30 days prior to study procedure. Cardiac surgery < 90 days prior to study procedure.
- •Myocardial infarction requiring intervention < 30 days prior to study procedure
- •Infiltrative cardiomyopathies (e.g., amyloidosis, hemochromatosis, sarcoidosis), hypertrophic or restrictive cardiomyopathies, and constrictive pericarditis)
- •Active peptic ulcer or upper gastrointestinal bleeding < 90 days prior to study procedure.
- •Stroke < 180 days prior to study procedure.
- •Severe COPD requiring oral steroid therapy or oxygen therapy.
- •Severe renal insufficiency (creatinine > 3.0 mg/dL) or patient requiring dialysis
- •Cardiogenic shock at time of enrolment. Hemodynamic instability requiring inotropic support or mechanical heart assistance.
- •Concurrent medical condition with a life expectancy of less than 2 years
- •Pregnancy or breastfeeding at time of enrolment with a positive pregnancy test within 14 days of study procedure.
- •History of bleeding diathesis or coagulopathy or leukopenia (WBC < 3,000 mcL) or acute anemia (Hb < 9 g/dL) or thrombocytopenia (platelets < 50,000 cells mcL)
- •Known hypersensitivity or contraindication to aspirin, heparin, ticlopidine or clopidogrel, nitinol, tantalum or allergy to contrast agents that cannot be pre-medicated.
- •Note. Patient must be able to tolerate at least one antiplatelet medication AND one anticoagulant medication.
- •Severe dementia or lack of capacity due to conditions that result in either inability to provide informed consent for the trial/procedure, prevent independent lifestyle outside of a chronic care facility, or will fundamentally complicate rehabilitation from the procedure or compliance with follow-up assessments.
- •Patient is in need for emergent or urgent surgery for any reason or any planned cardiac surgery within the next 12 months.
- •Company employees or their immediate family members.
- •Patient is considered to be part of a vulnerable population, is under guardianship, or subject to any other medical, social or psychological conditions that preclude appropriate consent and follow-up.
- •Patient is participating in another clinical study for which follow-up is currently ongoing.
研究组 & 干预措施
Treatment
Experimental
treatment with the study device
干预措施: MR-ace Implant and Delivery System (Device)
结局指标
主要结局
Primary Performance Endpoint
时间窗: 30 days post procedure
Reduction in mitral regurgitation (Grade 2+ or less) as evaluated by 2D transthoracic echocardiography.
Primary Safety Endpoint
时间窗: 30 days post procedure
All-cause mortality
次要结局
- Secondary Safety Endpoint(30 days, 6 months, 12 months, 2 years, 3 years, 4 years, and 5 years post procedure)
- Secondary Performance Endpoint(30 days, 6 months, 12 months, 2 yrs, 3 years, 4 years, and 5 years post procedure)
研究者
研究点 (3)
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