NCT03030274已完成不适用
Prospective, Non-randomized, Pilot Study to Assess Safety and Efficacy of a Novel Atrial Flow Regulator (AFR) in Heart Failure Patients With Reduced Ejection Fraction or in Heart Failure Patients With Preserved Ejection Fraction
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 106
- 试验地点
- 38
- 主要终点
- Serious Adverse Device Effects (SADE) within 3 month following implantation.
研究概览
简要总结
This study aims to investigate safety and efficacy of the Occlutech® AFR device in patients with HFrEF (Heart failure with reduced ejection fraction) and HFpEF (Heart failure with preserved ejection fraction)
详细描述
This study will enroll subjects with HFrEF or HFpEF, until a maximum of 100 patients have undergone implantation with the Occlutech® AFR device.
Enrolled patients will be stratified according to their ejection fraction as either HFrEF (ejection fraction > 15% and <40 %) or HFpEF ( ejection Fraktion > 40 % to 70 %). It is planned to enroll at least 100 patients per stratification subgroup.
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
- 未提供
排除标准
- •Local or generalized sepsis or other acute infection(s)
- •Any coagulation disorder, if clinically relevant in the opinion of the operator.
- •Allergy to nickel and/or titanium and/or nickel/titanium-based materials, if not medically manageable
- •Allergy to anti-platelet, -coagulant, or -thrombotic therapy, if not medically manageable
- •Intolerance to contrast agents, if not medically manageable
- •Participation in another medical trial testing a therapy less than 30 days before the intended AFR implantation procedure
- •Trans-oesophageal echocardiography and / or use of general anaesthetic is contraindicated
- •Breast feeding women
- •Processes which would technically disturb the safe intervention as planned:
- •Occluded inferior vena cava access
- •History of ASD and/or atrial septal repair or closure device in place
- •Intracardiac thrombus
- •Clinical conditions:
- •Moderate valvular diseases requiring therapy according to current ESC guidelines. Patients are eligible in case therapy is formally indicated but cannot be performed due to technical or medial reasons if the latter is confirmed in writing by the PI in mutual agreement with the heart team and Severe aortic stenosis with valve area < 1.5cm² and Severe AR, TR or MR. Classification of severity of regurgitation should follow the definition provided in Lancelotti et al, Eur Heart J Cardiovasc Imaging 2013 [22]
- •Patients who has unstable and intractable angina pectoris
- •Evidence of right heart failure defined as (by ECHO)
- •Severe Right Ventricular Dysfunction (TAPSE < 14 mm)
- •Severe Right Ventricular Dilatation (RV volume ≥ LV volume)
- •Severe pulmonary hypertension (PASP > 60 mm Hg)
- •Active malignancy
- •Severe valve disease, or implanted mechanical valve prosthesis
- •Congenital heart defect
- •Large PFO with significant atrial septal aneurysm (bubble test shows more than 20 bubbles)
- •Inability to perform 6-minutes walking test
- •Clinically relevant thrombocytopenia, thrombocytosis, leukopenia, or anemia
- •Symptomatic carotid artery disease
- •Mitral valve stenosis
- •Has any condition that, in the opinion of the Investigator, might interfere with the Implantation, might affect the patients well-being thereafter or might interfere with the conduct of the study
- •Systolic blood pressure of >170 mmHg, despite medical therapy
- •Severe lung disease (causing PHT with systolic PAP >60mmHg)
- •Pulmonary Hypertension (Systolic PAP >60mmHg)
- •TIA or stroke within the last 6 months
- •Scheduled for heart transplantation
- •Bleeding disorders (INR > 2.0, Thrombocytes < 100.000, Hemoglobin <8.0 gr/dl)
- •Myocardial infarction or percutaneous intervention or CABG (all within the last 3 month) or indication for a coronary intervention
- •Resyncronization therapy started within the last 6 months
- •Aneurysm of the septum
- •Hypertrophied Inter Atrial Septum (IAS) > 10mm depth
- •Hypertrophic Obstructive Cardiomyopathy (HOCM) or infiltrative CM as cause of HF
- •Thromboembolic events within the last 6 months
- •Dialysis and renal insufficiency requiring dialysis
结局指标
主要结局
Serious Adverse Device Effects (SADE) within 3 month following implantation.
时间窗: 0-3 month
Incidence of Serious Adverse Device Effects (SADE) following implantation such as: * device dislocation / embolization * damage to the tricuspid or mitral valve caused by the device * intractable arrhythmias caused by the device * any circumstances that require device removal.
次要结局
- Device placement(0-12 month)
- Serious Adverse Device Effects (SADE) between 3-12 month following implantation(3-12 month)
- Left to Right shunt through the AFR device(0-12 month)
研究者
研究点 (38)
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