ACTRN12607000531415招募中1 期
A trial investigating the safety and effectiveness of the HeartPOD as a hemodynamically guided home self-therapy in severe heart failure patients
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 85 Years（—）
- 性别
- All
入选标准
- •Age > 18 and 85.
- •Documented history of congestive heart failure resulting from ischemic or non-ischemic cardiomyopathy with systolic or diastolic dysfunction of at least 6 months duration.
- •American Heart Association(AHA)/American College of Cardiology(ACC) Stage C heart failure with New York Heart Association (NYHA) Class III or IV symptoms.
- •Baseline 6-minute walk distance <450 meters (1476 feet)
- •Minimum of one (1) prior hospital admission within the last 12 months for exacerbation of Congestive Heart Failure (CHF).
- •Female subjects of child-bearing potential must have a negative pregnancy test within seven (7) days before the procedure.
- •Central venous vascular access.
- •Capable of Valsalva maneuver with airway pressure > 40 mm Hg for =10 seconds.
- •The subject and the treating physician agree that the subject will comply with all required post – procedure follow-up, and that the patient is capable of correct device use as outlined in the protocol.
- •The subject or the subject’s legal representative has been informed of the nature of the study and agrees to it’s provisions and has provided written informed consent as approved by the ethics committee of the respective clinical site
排除标准
- •Intractable Heart Failure (HF) with resting symptoms despite maximal medical therapy (AHA/ACC Stage D) or active listing for cardiac transplantation.( 6 months survival expected)
- •Resting systolic blood pressure <90 or > 180 mm Hg.
- •Acute Myocardial Infarction (MI), unstable ischemic syndrome within the last 6 weeks.
- •Percutaneous coronary intervention (PCI) or cardiac surgery performed or planned within +/- six weeks.
- •Coexisting stenotic valve lesions, vegetations, hypertrophic cardiomyopathy, amyloidosis or other infiltrative heart disease, constrictive, restrictive disease, tamponade, or >moderate or large small pericardial effusion.
- •Surgical correction of congenital heart disease involving atrial septum
- •Cerebrovascular Accident (CVA) or Transient Ischaemic Attack (TIA) within 6 months. History of uncorrected cerebral vascular disease
- •Atrial thrombus or myxoma
- •Chronic atrial fibrillation
- •Symptomatic bradyarrhythmia or sustained Ventricular Tachycardia (VT)/Ventricular Fibrillation (VF) unless successfully treated with cardiac rhythm management device for >6 weeks.
- •Atrial septal thickness > 5 mm.
- •Atrial septal defect or patent foramen ovale > 2 mm in diameter.
- •Life expectancy < 1 year from malignancy, primary pulmonary hypertension, renal, hepatic, or neurological condition, etc.
- •Gastrointestinal bleeding during the last 6 months.
- •Coagulopathy or uninterruptible anticoagulation therapy or unable to take anti-platelet medications.
- •Creatinine >2.5 gm/dl (220umol/L).
- •Temperature >37.8 ?C or white blood cell count (WBC) >13,000/mm3.
- •The subject is currently participating in an investigational drug or another device study that has not completed the primary endpoint or clinically interferes with the current study endpoints.
研究者
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