NCT07363473尚未招募不适用
Transcatheter Therapy to Treat Aortic Regurgitation in the Presence of a Left Ventricular Assist Device
JC Medical, Inc., an affiliate of Edwards Lifesciences LLC0 个研究点目标入组 50 人开始时间: 2026年4月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 主要终点
- Primary Effectiveness Endpoint
研究概览
简要总结
The objective of this study is to assess the safety and effectiveness of the J-Valve Transfemoral Transcatheter Heart Valve System in patients on left ventricular assist device (LVAD) support with significant native aortic valve regurgitation (AR).
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
- •Adult with durable left ventricular assist device (LVAD) support and clinically significant AR (grade 4 or higher as assessed by core lab using TTE and adjunct TEE, if necessary) leading to LVAD dysfunction
- •Symptomatic according to New York Heart Association (NYHA) functional class II or higher
- •High risk for surgery as judged by a multi-disciplinary heart team
- •Suitable anatomy to accommodate the insertion, delivery, and deployment of the study devices (see anatomic exclusions below)
- •Written informed consent and agreement to comply with all required follow-up visits at investigational site
排除标准
- •Prior aortic valve replacement or repair
- •Aortic valve stenosis > moderate as assessed by core lab
- •Severe mitral valve or tricuspid valve regurgitation as assessed by core lab
- •Severe mitral valve or tricuspid valve stenosis as assessed by core lab
- •Active infection requiring current antibiotic therapy, including infective endocarditis
- •Cardiac imaging evidence of cardiac mass, thrombus or vegetation
- •Inability to tolerate or a condition precluding treatment with antithrombotic (antiplatelet, anticoagulant) therapy
- •Renal insufficiency (eGFR <25 mL/min/1.73m2) or end stage renal disease requiring chronic dialysis
- •Cirrhosis (Child-Pugh Class B or C)
- •Leukopenia (WBC <3000 cells/mcL), thrombocytopenia (platelet count <50,000 cells/mcL), anemia (hemoglobin <9 g/dL), history of bleeding diathesis, coagulopathy, or hypercoagulable state (unless therapeutically stable)
- •Known hypersensitivity or contraindication to aspirin, heparin, bivalirudin, clopidogrel, Nitinol (Nickel, Titanium) or sensitivity to contrast media which cannot be adequately premedicated
- •Clinically significant untreated coronary artery disease requiring revascularization or anticipated coronary revascularization procedure within 12 months post-index procedure
- •Acute myocardial infarction within 30 days prior to index procedure
- •PCI within 30 days prior to index procedure
- •Carotid intervention within 6 weeks prior to index procedure or carotid artery disease requiring intervention
- •Previous, or planned, other surgical or interventional procedures within 30 days before, during, or within 30 days after the index procedure
- •Uncontrolled atrial fibrillation
- •Severe right ventricular (RV) dysfunction or chronic inotrope support (>30 days)
- •Severe pulmonary hypertension (systolic pulmonary artery pressure >80 mmHg measured by right heart catheterization)
- •Severe chronic obstructive pulmonary disease (COPD) requiring chronic oral steroids or requiring continuous home oxygen
- •Stroke (cerebrovascular accident, CVA), transient ischemic attack (TIA) or neurological signs and symptoms attributed to carotid or vertebrobasilar disease within 90 days prior to index procedure
- •Estimated life expectancy of less than 12 months
- •Pregnancy or intent to become pregnant prior to completion of all protocol follow-up requirements
- •Participation in another investigational study that has not reached its primary endpoint
- •Considered to be part of a vulnerable population
- •Anatomic Exclusions:
- •Ascending aortic diameter ≥5.5 cm as assessed by core lab
- •Aortic annulus perimeter <57 mm or >104 mm as assessed by core lab
- •Inappropriate anatomy for femoral introduction and delivery of the study system
- •Congenital aortic valve disease including unicuspid, bicuspid, or quadricuspid aortic valve anatomy as assessed by core lab
- •Congenital univentricle or other condition that, in the opinion of the investigator and/or consulting physician, may constitute an unwarranted surgical risk
- •Excessive aortic valve prolapse or leaflet deterioration that would preclude proper seating of the implant in the aortic annulus
- •Abdominal/thoracic aortic aneurysm ≥5.0 cm as assessed by core lab
- •Aorto-iliac disease requiring intervention to facilitate delivery of access sheath
- •Excessive tortuosity of delivery system pathway, defined as severe tortuosity of multiple vessels including iliofemoral, thoracoabdominal aorta, aortic arch, and/or LV-aortic root angle >80°
研究组 & 干预措施
J-Valve Transfemoral System
Experimental
干预措施: J-Valve Transfemoral System (Device)
结局指标
主要结局
Primary Effectiveness Endpoint
时间窗: 30 days
Freedom from moderate or severe total aortic regurgitation
Primary Safety Endpoint
时间窗: 30 days
Freedom from all-cause mortality
次要结局
- Valve embolization(During index procedure)
- Need for second bioprosthetic valve(During index procedure)
- Change in cardiovascular-specific health status(30 days compared with baseline)
研究者
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