NCT07503236招募中不适用
ENHANCE EFS: Early Feasibility Study (EFS) of the Nyra Cardiac Leaflet Enhancer (CARLEN) System
Nyra Medical, Inc.3 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2026年7月2日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 3
- 主要终点
- Primary Endpoint
研究概览
简要总结
Safety and performance evaluation of the CARLEN System in patients with functional mitral valve regurgitation.
详细描述
The purpose of this early feasibility study (EFS) is to evaluate the safety and performance of the CARLEN System in patients with symptomatic, moderate-to-severe or severe (MR ≥ 3+), functional (or secondary) mitral regurgitation.
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
- •Age > 21 years at time of enrollment
- •Patient has provided informed consent, is willing and capable of participating in all testing, and agrees to return for all required post-procedure follow-up visits
- •Moderate-to-severe or severe (MR ≥ 3+) functional (secondary) mitral valve regurgitation
- •Symptomatic with mitral regurgitation (NYHA Class II, III, or ambulatory IV) despite maximally-tolerated guideline-directed medical therapy (GDMT) as determined by the local multidisciplinary Heart Team
- •Patient is suitable for transcatheter mitral valve repair as determined by the local multidisciplinary Heart Team and confirmed by the Eligibility Committee
排除标准
- •Estimated life expectancy of less than 12 months
- •Women who are pregnant, lactating, or planning to become pregnant during the clinical study. Women of child-bearing potential must have negative pregnancy test result within 2 weeks prior to the procedure
- •Left Ventricular Ejection Fraction (LVEF) < 20%
- •Left ventricular end diastolic diameter (LVEDD) > 75 mm
- •Acute hemodynamic decompensation
- •Known hypersensitivity or contraindications to necessary and routine medications including contrast compounds or components used in the CARLEN System that cannot be successfully pre-medicated, including nitinol, an alloy of nickel and titanium
- •Contraindicated for transesophageal echo (TEE)
- •Presence of other anatomical characteristics and/or significant comorbidities that in the judgement of the Investigator or Eligibility Committee precludes the subject from participation
- •Aortic valve disease requiring intervention or intervention
- •Severe or greater tricuspid regurgitation
- •Severe right ventricular dysfunction
- •Severe pulmonary hypertension
- •Presence of significant congenital heart disease
- •Planned or scheduled cardiac surgery within next 12 months
- •Endocarditis within last 90 days
- •Evidence of intracardiac mass, vegetation, or inflammatory or infectious valve disease
研究组 & 干预措施
CARLEN System
Experimental
CARLEN System
干预措施: CARLEN System (Device)
结局指标
主要结局
Primary Endpoint
时间窗: 30-days post-procedure
Freedom from device- or procedure-related serious adverse events through 30-days post-procedure
次要结局
未报告次要终点
研究者
研究点 (3)
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