NCT02499601招募中不适用
CORolla® TAA for Heart Failure With Preserved Ejection Fraction (HFpEF) and Diastolic Dysfunction (DD) Safety and Feasibility
CorAssist Cadiovascular Ltd.2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2015年9月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Number of participants with All-cause mortality and Serious Adverse Events (SAEAs)
研究概览
简要总结
The study objective is to demonstrate safety and feasibility of the CORolla® TAA during 12 months of follow up, and to evaluate the performance of the therapy in relieving symptoms and restore diastolic function in patients with heart failure and preserved ejection fraction.
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
- •Clinical criteria:
- •Adult (age > 18 years)
- •Diagnosis of heart failure with preserved ejection fraction
- •NYHA F. Class III or IV or documented history of at least two heart failure hospitalization in the past year prior to enrollment.
- •No contraindication for anticoagulation and antiplatelet treatment.
- •Optimal medical cardiovascular pharmacotherapy with stable doses for at least 4 weeks (not including diuretics)
- •Pulmonary Wedge pressure > 15 mmHg documented by right heart catheterization at enrollment.
- •Patient understands the study requirements and the treatment procedures and provides written Informed Consent before any study-specific tests or procedures are performed
- •Patient is able and willing to adhere to the required follow-up visits and testing
- •Minimal endocardial height from Apex to Mitral Annulus > 60mm at end systole
- •Echocardiographic criteria:
- •Left ventricular ejection fraction≥50%
- •HFpEF diagnosis according to ESC 2016 guidelines
- •No evidence of intra-cardiac thrombus
- •Cardiovascular disease:
- •Implanted or planned implantation of defibrillator devices such as ICD cardiac resynchronization device (CRT-D) or left ventricular assist device (LVAD).
- •Within the past 3 months - Acute myocardial infarction (AMI), cerebral vascular accident (CVA), or Transient Ischemic Attack (TIA).
- •History of thrombus within the previous 3 months.
- •Coronary Artery Bypass Surgery (CABG), valve replacement or repair, aortic surgery or percutaneous coronary intervention (PCI in the past 3 months or planned/anticipated within the coming 6 months. Patients with mechanical valve replacement or CABG performed more than 3 months before may be eligible for enrollment.
- •Significant valvular disease classified as
- •Moderate or severe aortic stenosis/regurgitation
- •Moderate or severe mitral stenosis
- •Severe mitral regurgitation
- •Hypertrophic cardiomyopathy
- •History of pericardial disease.
- •HF attributed to Cor pulmonale or other cause of isolated right heart failure.
- •Moderate to severe right ventricle failure or right ventricular myocardial infarction.
- •Infiltrative heart disease including amyloidosis.
- •Non-cardiovascular disease:
- •Prior surgery, radiation, or thoracic surgery limiting the ability to place the device.
- •Moderate to severe asthma or COPD, or severe restrictive lung disease.
- •Severe chronic renal failure indicated by MDRD GFR <30 mL/min/1.73 m
- •Liver impairment addressed by bilirubin > 2 mg/dl and serum albumin <3 g/dL
- •Severe anemia addressed by Hb concentration <9 gr/l.
- •Solid organ or hematologic transplant.
- •Previous Trans Apical procedures/implantation.
- •Miscellaneous conditions:
- •Co-morbid condition that in the physician's opinion would prohibit the subject's ability to meet the protocol requirements.
- •Pregnancy at the time of enrollment. (Women of childbearing potential must have a negative serum pregnancy test within two weeks prior to enrollment, or be using hormonal contraceptives or intrauterine devices).
- •Participating in another treatment investigational study.
- •A history of alcohol abuse, drug addiction, or other psychosocial condition that would preclude successful participation, or clear judgment and informed consent in the opinion of the Principal Investigator.
排除标准
- 未提供
结局指标
主要结局
Number of participants with All-cause mortality and Serious Adverse Events (SAEAs)
时间窗: 6 months
Investigational device safety with the intended study population with respect to 6 months follow up will be demonstrated using the following: All-cause mortality and Serious Adverse Events (SAEAs) throughout 6 months post-surgery.
Incidence of in-hospital procedure success.
时间窗: up ot 24 hour.
Success of the implant surgical procedure and ability to position the CORolla® TAA will be determined according to Implantation Rating Questionnaire.
次要结局
- Device impact on diastolic dysfunction markers assessed by conventional echocardiography imaging and novel approach including Tissue Doppler Imaging (TDI).(up to 24 months)
- Rate of HF death and re-hospitalization due to HF (including IV diuretic)(12 months)
- Rate of device related Major Adverse Cardiac and Neurological Events (MACNE)(up to 6 months)
- Changes in cardiac medications, including daily diuretic dose.(up to 24 months)
- Rate, type and severity of procedure related and device-related events(30 days)
- Change in New York Heart Association functional Class (NYHA f. Cl).(up to 24 months)
- Change of Wedge pressure(up to 24 months)
- Change in VO2 Max(up to 24 months)
- Change in Quality of Life (QoL) Questionnaire(up to 24 months)
- Change in exercise capacity as measured by the Six-Minute Walk test.(up to 24 months)
- Change in Pulmonary Capillary Wedge Pressure during handgrip/ergometry(up to 24 months)
- Change in exercise testing during echocardiography(up to 24 months)
研究者
研究点 (2)
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