First Human Study of Sutra Hemi-Valve to Evaluate Safety and Efficacy in Patients With Mitral Regurgitation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Primary Safety Endpoint - The ability of the Sutra Hemi-valve to be placed without Major Device Related Adverse Events through thirty (30) days
研究概览
简要总结
Study to evaluate the feasibility, safety and performance of the Sutra Hemi-valve Transcatheter Mitral Valve Replacement System in patients with moderate-severe and severe symptomatic mitral regurgitation who are at high risk for surgical treatment.
详细描述
Investigational Device:
Sutra Transcatheter Mitral Valve Replacement (TMVR) System The Sutra Hemi-valve TMVR System consists of 32Fr delivery devices and an implantable hemi-valve.
The Sutra Hemi-valve consists of a self-expanding nitinol frame, a tri-leaflet bovine pericardial hemi-valve, and a sealing skirt. The Sutra Hemi-valve is intended to replace the posterior leaflet of the mitral valve to treat mitral regurgitation. The frame consists of an atrial portion for anchoring to the native annulus, and a ventricular portion which houses the Hemi-valve. The atrial section of the Sutra Hemi-valve contains three through-holes for anchoring to Dual-guiding-and-fixation (DGF) devices implanted at the lateral trigone (T1), the medial trigone (T3), and in the center of the posterior annulus (P2). The Sutra Hemi-valve comes in two sizes: Size 42 and Size 38.
Intended Use: The Sutra Hemi-valve TMVR system is intended for use as a partial replacement mitral valve.
Indication for Use: The Sutra Hemi-valve TMVR system is indicated for use in patients with moderate-severe or severe symptomatic mitral regurgitation who are considered high risk for conventional mitral valve surgery.
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
- •Subject is greater than 18 years of age at time of enrollment.
- •Subject has moderate-severe or severe symptomatic mitral regurgitation who are considered high surgical risk for conventional mitral repair or replacement, as assessed by institutional multidisciplinary heart team.
- •New York Heart Association (NYHA) Functional Class II and above.
- •Subject anatomy is suitable for transfemoral and transeptal device delivery and meets sizing criteria for Sutra Hemi-valve TMVR System.
- •Subject willing and able to provide informed consent and able to comply with the study protocol and follow up.
- •Female subjects of childbearing potential have a negative pregnancy test ≤ 7 days before the procedure
排除标准
- •Prohibitive mitral annular calcification
- •Diseased mitral anterior leaflet such as flail or prolapse
- •Previous mitral valve intervention
- •Implanted with venous stents (iliac and femoral) including inferior vena cava (IVC) filter or congenital abnormalities of the IVC that would preclude ability for transfemoral access with the delivery system.
- •Evidence of intra-cardiac, inferior vena cava (IVC) or ipsilateral femoral venous thrombus
- •Severe aortic stenosis or insufficiency (Note: may be treated ≥ 30 days prior to study procedure)
- •Contraindication for transesophageal echocardiography (TEE) or MDCT scan
- •Active infections requiring current antibiotic therapy (if temporary illness, patients may enroll 2 weeks after discontinuation of antibiotics)
- •Endocarditis within 6 months
- •Left ventricular ejection fraction (LVEF) < 25%
- •Severe Chronic Obstructive Pulmonary Disease (COPD) demonstrated by Forced Expiratory Volume (FEV1) < 750cc
- •Implant or revision of any pacing device < 30 days prior to intervention
- •Symptomatic coronary artery disease treated < 30 days prior to study procedure
- •Active peptic ulcer or upper gastrointestinal bleeding within 90 days
- •Prior stroke, TIA, or myocardial infarction within 90 days
- •Severe renal insufficiency (creatinine > 225 µmol/L) or patient requiring dialysis
- •Any endovascular therapeutic interventional or surgical procedure performed within 30 days prior to enrollment
- •Pregnant, nursing or planning to be pregnant. (Female participants of childbearing potential must have a negative pregnancy test prior to enrollment)
- •History of bleeding diathesis or coagulopathy that cannot be managed or patient will refuse blood transfusion
- •Hemodynamic instability requiring dependency on either inotropic agents or mechanical circulatory support
- •Known hypersensitivity or contraindication to heparin and bivalirudin
- •Known allergy to nitinol or contrast agents that cannot be pre-medicated
- •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 participating in another investigational drug or device clinical study that has not completed primary endpoint follow-up
结局指标
主要结局
Primary Safety Endpoint - The ability of the Sutra Hemi-valve to be placed without Major Device Related Adverse Events through thirty (30) days
时间窗: Day 30
including: * Death (Cardiovascular mortality vs non-cardiovascular); * Reintervention (operative or transcatheter) due to progressive or recurrent MR or device related complications; * Disabling stroke; * Myocardial infarction (MVARC); * Major access site and vascular complications; * Fatal or life-threatening bleeding (MVARC Type III-V); * Renal Failure requiring dialysis; * Cardiac tamponade.
Primary Performance Endpoint - Sutra Hemi-valve TMVR System Technical Success
时间窗: Day 0
defined as: successful access, delivery, and retrieval of the delivery system; and successful deployment and correct positioning of the implant; and no need for additional emergency surgery or re-intervention related to the investigational device or index procedure.
次要结局
- 6 Minute Walk Test distance (6MWT)(Day 30, Month 6, Month 12)
- Change in NYHA functional class(Day 30, Month 6, Month 12)
- Intra-procedure MR severity is reduced by at least 1 grade from baseline per echo (e.g., from severe to moderate).(Day 0)
- MR severity grade per Echo(Day 30, Month 6, Month 12)
- Post-index procedure (discharge or within 7 Days post-index procedure, whichever is earliest) MR severity is reduced by at least 1 grade from baseline per echo (e.g., from severe to moderate).(Day 0 - Day 7)