Mitralign Percutaneous Annuloplasty First in Man (FIM) Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 10
- 主要终点
- The primary study endpoint will assess acute safety defined as the incidence of Device-related NACE (net adverse clinical events which includes Device Related Mortality, MI, Cardiac Tamponade and stroke) at 30 days
研究概览
简要总结
The purpose of this study is to assess the safety and feasibility of the Mitralign Percutaneous Annuloplasty System in humans for the treatment of chronic functional mitral regurgitation. No formal test of hypothesis is proposed for this trial.
详细描述
The primary objective of this study is to test the ability to safely perform mitral posterior annulus plication with the Mitralign System in eligible patients with chronic functional MR using an endovascular approach. Data obtained from this study, combined with extensive pre-clinical data, will provide important technical and early clinical outcome information that will drive the next phase of clinical investigation and potentially enhance the future design of the Mitralign Percutaneous Annuloplasty System. It is anticipated that the Mitralign System will one day provide physicians with a safe and effective alternative therapy for treating patients who are candidates for mitral valve repair and offer a primary therapy option for patients superior to current treatment modalities.
This is a single-arm, multi-center, prospective study designed to test the safety and feasibility of the MPAS to treat patients with chronic, functional MR by performing plication of the posterior mitral annulus.
Up to a total of 36 patients with chronic functional mitral regurgitation will be enrolled: 1.) Up to 16 patients (12 patients + 1 roll-in patient per site) will be enrolled in Phase I. Up to thirty-four (34) patients will be enrolled in Phase II (MITRALIGN ADVANTAGE). All patients will be followed for 24 months. Up to 5 sites in Europe and South America will participate.
Study procedures include implantation of the MPAS, Trans-Esophogeal Echo, Trans-Thoracic Echo, Blood test, 6-min walk, Quality of Life, Chest X-ray and ECG.
Descriptive Statistics will be conducted for this study.
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
- •Patient with chronic functional mitral regurgitation.
- •Patient is greater than 18 years old.
- •Documented symptoms of CHF - NYHA II-IV.
- •Left ventricular ejection fraction between 30 and 60 percent.
- •Acceptable candidate for cardiac surgery and/or blood transfusion.
- •Patient or legal guardian understands the study requirements and the treatment procedures and provides written Informed Consent before any study- specific tests or procedures are performed.
- •Willing to comply with all specified follow-up evaluations.
- •Mitral regurgitation grade
- •Patient has a mitral plane to apex dimension 5 cm.
- •Structurally normal mitral valve.
排除标准
- •Patient with significant organic mitral valve pathology such as myxomatous degeneration, mitral valve prolapse or flail leaflets moderate or severe valve calcifications, ruptured papillary muscles or ruptured chordae tendinae.
- •Previous mitral valve repair or mitral valve replacement.
- •Patient with mitral stenosis.
- •Patient with moderate or severe aortic stenosis and or moderate or severe aortic regurgitation.
- •Patient with endocarditis.
- •MI within 30 days prior to the index procedure.
- •Unstable angina.
- •Percutaneous Coronary Intervention within 30 days prior to the index procedure.
- •CABG within 3 months prior to the index procedure.
- •Planned PCI less than 30 days post index procedure.
- •Planned CABG within 6 months post index procedure.
- •Patient with severe, multivessel coronary artery disease and who cannot tolerate sudden hemodynamic changes or acute hemoglobin drop.
- •Cardiogenic Shock characterized by systolic pressure less than 80 mm Hg and or central filling pressure greater than 20 mm Hg, or cardiac index less than 1.8 liters per minute per m2 or intra-aortic balloon pump or intravenous inotropes are needed to maintain a systolic pressure greater than 80 mm Hg and a cardiac index greater than 1.8 liters per minute per m
- •Patient with peripheral vascular disease or tortuousity that would prevent percutaneous access with a 14 Fr introducer sheath or intervention with the Mitralign system.
- •Cerebrovascular Accident within the past 6 months.
- •Acute or chronic renal dysfunction creatinine greater than 2.0mg per dl or 177µmolper dl
- •Anemia Hb greater than 10 g per dl.
- •Thrombocytopenia platelet count less than 100,000 per mm3) or thrombocytosis platelet greater than 750,000 per mm3).
- •Bleeding disorders or hypercoaguable state.
- •Active peptic ulcer or active gastrointestinal bleeding.
- •Contraindication to therapy with antiplatelet or anticoagulant drugs.
- •Contraindications to or patient's refusal of blood transfusions.
- •Known allergy to stainless steel or platinum iridium or polyester.
- •Any prior true anaphylactic reaction to contrast agents defined as known anaphylactoid or other non-anaphylactic allergic reactions to contrast agents that cannot be adequately pre-medicated prior to the index procedure.
- •Pregnancy or female of childbearing potential with a positive pregnancy test within 24 hours before the index procedure or undergoing any angiography or x-ray, or lactating.
- •Co-morbid condition(s) that could limit the patient's ability to participate in the study, compliance with follow-up requirements or impact the scientific integrity of the study.
- •Life expectancy of less than 24 months due to other medical condition.
- •Currently participating in another investigational drug or device study that has not completed the primary endpoint or that clinically interferes with the endpoints of this study.
- •Patient with impaired judgment.
- •Patient having to undergo emergency treatment.
- •Thrombus in left ventricle or left atrium.
- •Echocardiographic evidence of congenital, pericardial or infiltrative heart disease.
- •Suboptimal echocardiographic (TTE) windows, leading to incomplete quantification of FMR or anatomic assessment.
- •Significant subvalvular trabecularization, muscle bridges and pockets
结局指标
主要结局
The primary study endpoint will assess acute safety defined as the incidence of Device-related NACE (net adverse clinical events which includes Device Related Mortality, MI, Cardiac Tamponade and stroke) at 30 days
时间窗: 30 Days post implant
The primary study endpoint will assess acute safety using a composite clinical endpoint of device-related net adverse cardiac events (NACE) at 30 days. The components of NACE are defined as the occurrence of device related mortality, myocardial infarction, cardiac tamponade, cardiac surgery or stroke in per protocol population
次要结局
- Echocardiographic measures(6 Months)