Transcatheter Aortic Valve Replacement Using the JenaValve TrilogyTM Heart Valve System for Clinically Significant Aortic Regurgitation in Patients With Left Ventricular Assist Devices (LVAD)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 50
- 试验地点
- 20
- 主要终点
- Device Success
研究概览
简要总结
To evaluate the safety and effectiveness of the JenaValve Trilogy™ Heart Valve System for transcatheter aortic valve replacement (TAVR) in subjects with continuous flow left ventricular assist devices (cfLVAD) and clinically significant aortic regurgitation (AR) who are indicated for TAVR
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
- •Subjects >=18 years of age with continuous flow LVAD (cfLVAD) with clinically significant AR1 leading to cfLVAD dysfunction using cfLVAD ASE guidelines that utilize contemporary management strategies for measurement of AR in patients with cfLVAD2,3:
- •AR is graded from 0 to 6 (0 = none; 1 = trace; 2 = mild; 3 = mild-to-moderate; 4 = moderate; 5 = moderate-to-severe; 6 = severe). Considering that AR during continuous flow LVAD (cfLVAD) support is generally both systolic and diastolic, AR is deemed significant if graded ≥ 3.1
- •Patient with NYHA functional class III/IV
- •Patient with high risk for SAVR as documented by Heart Team.
- •Patient has suitable anatomy to accommodate the insertion and delivery of the JenaValve Trilogy™ Heart Valve System
- •Patient or the patient's legal representative has provided written informed consent
- •Patient or the patient's legal representative agrees to comply with all required post-procedure follow-up visits
排除标准
- •Congenital uni- or bicuspid (Sievers 0) aortic valve morphology
- •Previous prosthetic aortic valve (bioprosthesis or mechanical) implant
- •Mitral regurgitation > moderate
- •Clinically significant coronary artery disease (CAD) requiring revascularization within 30 days prior to index procedure, or planned CAD revascularization procedure within 12 months after index procedure
- •Echocardiographic or CT evidence of left ventricular or aortic valve thrombus
- •Ongoing sepsis or active infective endocarditis with ongoing antibiotic (including suppressive) therapy or positive blood cultures within 6 weeks
- •Hypertrophic cardiomyopathy with or without obstruction
- •Severe pulmonary hypertension (systolic PA pressure >80 mmHg)
- •Decompensated right heart failure as assessed clinically and, if available, by baseline right heart catheterization hemodynamics (e.g., right atrial pressure > pulmonary capillary wedge pressure and cardiac index < 2.5 L/min/m2
- •Severe RV dysfunction as assessed clinically and by echocardiography
- •Aortic annular diameter of <21.0 mm or > 28.6 mm (assessed by Multi-detector CT measurement)
- •Aortic annulus angulation > 70° (assessed by Multi-detector CT measurement)
- •Straight length of ascending aorta of < 55 mm
- •Significant disease of ascending aorta, including ascending aortic aneurysm (defined as maximal luminal diameter of 50 mm or greater) or atheroma (including if thick [>5 mm], protruding or ulcerated)
- •Myocardial infarction < 30 days prior to index procedure
- •Cerebrovascular event (TIA, stroke) < 180 days prior to index procedure
- •Blood dyscrasias as defined: leukopenia (WBC < 3000/mm³), or thrombocytopenia (platelets < 90,000/μl) or anemia (Men: Hgb < 8.1 g/dl; Women: Hgb < 7.4 g/dl)
- •Active peptic ulcer or upper gastrointestinal bleeding < 90 days prior to index procedure
- •Known hypersensitivity or contraindication to aspirin, heparin, ticlopidine or clopidogrel, nitinol, tantalum or allergy to contrast agents that cannot be premedicated
- •Subject unable to undergo pre-procedure transesophageal echocardiography or Multi-Detector CT (MDCT) scan for aortic annular sizing
- •Patient is enrolled in another investigational medical device or drug study which has not completed the required primary endpoint follow-up. (Note: Patients involved in a long-term surveillance phase of another study are eligible for enrollment in this registry)
研究组 & 干预措施
TAVR in LVAD Patients
Transcatheter Aortic Valve Replacement (TAVR)
TAVR in patients with continuous flow left ventricular assist devices (cfLVAD) and clinically significant aortic regurgitation (AR)
干预措施: JenaValve Trilogy Heart Valve System (Device)
结局指标
主要结局
Device Success
时间窗: 30 days
Freedom from unsuccessful delivery of the device, and retrieval of the delivery system
All Stroke
时间窗: 30 days
Number of patients that had stroke
Acute Kidney Injury
时间窗: 30 days
Number of patients that had acute kidney injury (AKI) stage 3 or 4
Total aortic regurgitation
时间窗: 30 days
Number of patients that had moderate or severe total aortic regurgitation
Device Positioning
时间窗: 30 days
Freedom from incorrect positioning of a single prosthetic heart valve into the proper anatomical location
Device Performance
时间窗: 30 days
Intended performance of the valve (i.e., no moderate or severe prosthetic valve regurgitation)\*
Surgery/intervention related to device
时间窗: 30 days
Freedom from surgery or intervention related to the device# or to a major vascular or access-related or cardiac structural complication
Bleeding
时间窗: 30 days
Freedom from VARC type 2-4 bleeding
Major Vascular Complication
时间窗: 30 days
Number of patients that had major vascular, access-related, or cardiac structural complication
Permanent pacemaker implantation
时间窗: 30 days
Number of patients that had these events
All-cause mortality
时间窗: 30 days
All-cause mortality within the first 30 days post index procedure
次要结局
- Device Success(30 days and 1 year)
- Device Positioning(30 days and 1 year)
- Device Performance(30 days and 1 year)
- Surgery/intervention related to device(30 days and 1 year)
- Bleeding(30 days and 1 year)
- All Stroke(30 days and 1 year)
- Acute Kidney Injury(30 days and 1 year)
- Total aortic regurgitation(30 days and 1 year)
- Major Vascular Complication(30 days and 1 year)
- Permanent pacemaker implantation(30 days and 1 year)
- All-cause mortality(30 days and 1 year)