Early Feasibility Study of the Cardiovalve Transfemoral Mitral Valve System
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 3
- 主要终点
- Cardiovalve to be implanted without Major Device Related Adverse Events through 30 Days including:
研究概览
简要总结
This study is to evaluate the safety and technical performance of the Cardiovalve Transfemoral Mitral Valve System with its associated procedure, to minimize mitral regurgitation. Data collected in this clinical study will include 30-day safety and performance of the device and delivery system, and long-term clinical outcomes over a follow-up of 5 years.
详细描述
The Cardiovalve offers a replacement valve delivered through a transfemoral access and transseptal approach, and is intended to reduce mortality and adverse event rates in selected patients for whom surgical options are not feasible.
Innovation: A truly transfemoral, trans venous delivery of the valve which minimizes procedural risk. The Cardiovalve implant has a very low left ventricle (LV) protrusion footprint thus reducing the risk of LV outflow tract obstruction and/or interference with the LV. The experience to date is limited but thus far none of the clinical programs has been halted for safety reasons. Most of the technologies have focused on a transapical delivery approach (with mini-thoracotomy access) to further simplify the delivery method, with only a few allowing trans-septal delivery with femoral venous access.
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 84 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •85>Age ≥ 18 years
- •Symptomatic (Stage D) severe MR confirmed by the echo core lab
- •Cardiac Index > 2.0
- •Left Ventricular Ejection Fraction (LVEF) is ≥ 30% (within 90 days prior to subject enrollment based upon TTE)
- •New York Heart Association (NYHA) Functional Class II, III or ambulatory IVa
- •Prior treatment with Guideline Directed Medical Therapy (GDMT) for heart failure for at least 30 days prior to index procedure
- •Patient deemed a high surgical risk per MVARC definition by the site's Heart Team (as a minimum, one MV cardiac surgeon and one interventional cardiologist, and a cardiac imaging expert).
排除标准
- •MR etiology that is exclusively Primary (degenerative)
- •Echocardiographic or angiographic evidence of severe mitral annular calcification
- •Echocardiographic evidence of EROA < 0.3cm2
- •Untreated clinically significant coronary artery disease requiring revascularization.
- •Hypertrophic/restrictive cardiomyopathy, constrictive pericarditis, or other structural heart disease causing heart failure other than other than cardiomyopathy of either ischemic or non-ischemic etiology
- •Hypotension (systolic pressure < 90 mm Hg)/Cardiogenic shock or other hemodynamic instability requiring the need for inotropic
- •Fixed pulmonary artery systolic pressure > 2/3 of systemic systolic blood pressure
- •LVEDD >75 mm
- •Severe tricuspid regurgitation or evidence of severe right ventricular dysfunction.
- •Anatomy deemed not suitable for the Cardiovalve
- •Elevated Creatine Kinase-MB (CK-MB)
- •UNOS Status 1 heart transplant or prior orthotropic heart transplantation.
- •Life Expectancy < 1 year due to non-cardiac conditions
- •NYHA functional class IVb
- •Chronic Kidney Disease with Creatinine clearance <30 ml/min/1.73m2
- •Any prior mitral valve surgery or transcatheter mitral valve procedure
- •Stroke or transient ischemic event within 30 Days prior to index procedure
- •Modified Rankin Scale > 4 disability
- •Class I indication for biventricular pacing (in patient with CRT device not implanted)
- •Implant or revision of any rhythm management device (CRT or CRT-D) or implantable cardioverter-defibrillator within one month prior to index procedure
- •Need for cardiovascular surgery (other than MV disease)
- •Echocardiographic evidence of intracardiac mass, thrombus, or vegetation
- •Active endocarditis
- •Known severe symptomatic carotid stenosis (> 70 % via ultrasound)
- •Active infections requiring current antibiotic therapy
- •Active cancer with expected survival < one year
- •Pregnant or planning pregnancy within next 12 months.
- •Currently participating in an investigational drug or another device study
- •Any condition making it unlikely the patient will be able to complete all procedures
- •Patient (or legal guardian) unable or unwilling to provide written, informed consent before study enrollment
- •Subjects in whom transesophageal echocardiography is contraindicated
- •Known hypersensitivity or contraindication to procedural, post procedural medication (e.g., contrast solution, heparin, anticoagulation therapy) or hypersensitivity to nickel or titanium.
研究组 & 干预措施
Cardiovalve Transfemoral Mitral Valve
Replacement valve delivered through a transfemoral access and transseptal approach
干预措施: Cardiovalve Transfemoral Mitral Valve (Device)
结局指标
主要结局
Cardiovalve to be implanted without Major Device Related Adverse Events through 30 Days including:
时间窗: 30 Days
1. Death (Cardiovascular mortality vs non-cardiovascular); 2. Reintervention (operative or transcatheter) due to progressive or recurrent MR or device related complications; 3. Disabling Stroke; 4. Myocardial infarction (MVARC definition); 5. Major access site and vascular complications 6. Fatal or Life-threatening bleeding (MVARC Type III- V) 7. Life-threatening arrhythmia; 8. Renal Failure requiring dialysis;
Cardiovalve Technical Success
时间窗: 30 Days
1. Successful access, delivery and retrieval of the delivery system; and 2. Successful deployment and correct positioning of the first intended implant; and 3. Freedom from emergency surgery or reintervention related to the device or access procedure Without any procedural mortality, stroke, and device dysfunction (Central MR grade \> 1 or paravalvular leak moderate or severe, mean mitral gradient \> 6 mm Hg, LVOT obstruction (gradient increase ≥10 mm Hg)) at 30-day follow up.
次要结局
- Change in LV end systolic volume index (LVESVI)(30 days, 3 months, 6 months)
- Kansas City Cardiomyopathy Questionnaire (KCCQ) score(30 days, 3 months, 6 months)
- 6-minute walk test (6MWT) distance(30 days, 3 months, 6 months)
- Clinical Frailty Score(30 days, 3 months, 6 months)
- Change in LV end diastolic volume index (LVEDVI)(30 days, 3 months, 6 months)
- Mitral Regurgitation severity(30 days, 3 months, 6 months)
- Changes in New York Heart Association (NYHA) functional class(30 days, 3 months, 6 months)