Mitral Valve Repair Clinical Trial (MAVERIC Trial)
试验速览
- 阶段
- 不适用
- 发起方
- Mvrx, Inc.
- 入组人数
- 51
- 试验地点
- 12
- 主要终点
- Major Adverse Event Rate to 30 Days post-procedure
研究概览
简要总结
The objective of the study is to evaluate the safety and performance of the ARTO System in patients with mitral valve regurgitation (MR) associated with congestive heart failure (CHF).
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
- •Is ambulatory, able and willing to comply with the study protocol and has provided written informed consent
- •Trans-septal catheterization is determined to be feasible by the treating physician
- •NYHA class II-IV heart failure of any etiology
- •Symptomatic with MR grade ≥ 2+
- •LVEF ≥20% ≤ 50%
- •LVEDD > 50 mm and ≤ 70 mm
- •No anticipated change in patient's cardiac medication regimen anticipated throughout the course of the study.
- •In the opinion of the investigator and heart surgery team, the patient is not a candidate for surgery, and the use of the ARTO™ System is technically feasible.
排除标准
- •In the opinion of the Investigator, the femoral vein and internal jugular vein cannot accommodate a 16 F catheter or the presence of an inferior vena cava (IVC) filter would interfere with advancement of the catheter or ipsilateral DVT is present
- •Significant structural abnormality of the mitral valve (e.g., flail, prolapse, leaflet calcification)
- •Significant mitral annular calcification
- •Hemodynamic instability (systolic pressure < 90 mmHg without afterload reduction or cardiogenic shock or the need for inotropic support or intra-aortic balloon pump)
- •Prior mitral valve surgery or valvuloplasty or any currently implanted prosthetic valve or VAD
- •History of, or active, rheumatic heart disease
- •History of Atrial Septal Defects (ASD), whether repaired or not
- •History of previously repaired PFO or PFO associated with clinical symptoms (e.g., cerebral ischemia) within 6 months of the planned investigational procedure
- •In the opinion of the investigator, an atrial septal aneurysm is present that may interfere with transseptal crossing
- •Biventricular pacing initiated or anticipated within 6 months of the planned investigational procedure
结局指标
主要结局
Major Adverse Event Rate to 30 Days post-procedure
时间窗: <=30 days post procedure
Major Adverse Events defined as: death, myocardial infarction, cardiac tamponade, device related cardiac surgery, stroke, renal failure
Mitral regurgitation grade and change from baseline to 30 days
时间窗: <=30 days post procedure
Device Technical Success
时间窗: procedural
At exit from cath lab, alive, with Successful access, delivery and retrieval of the device delivery system, and Deployment and correct positioning (including repositioning/recapture if needed) of the single intended device, and No need for additional unplanned or emergency surgery or re-intervention related to the device or access procedure
次要结局
未报告次要终点