NCT01543022Unknown1 期
First in Man Study - a Prospective, Multicenter, Single Arm Trial to Investigate the Safety and Feasibility of the Symphony Device
适应症
干预措施
试验速览
- 阶段
- 1 期
- 发起方
- Abiomed Inc.
- 入组人数
- 10
- 试验地点
- 3
- 主要终点
- Death, Stroke or Transient Ischemic Attack (TIA), Limb Ischemia requiring surgical intervention
研究概览
简要总结
The Counter Pulsation Device (CPD) System 'Symphony' is intended to provide counter pulsation therapy for up to thirty (30) days to patients with chronic heart failure who have persistent worsening of their condition despite optimal medical therapy. Patients will be in New York Heart Association (NYHA) Class IIIb or IV heart failure and have exhausted all medical or surgical options.
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •New York Heart Association Class IIIB or IV heart failure despite optimal medical therapy, including ACE inhibitors, beta blockers, IV diuretics and pressors
- •Left Ventricular Ejection Fraction < 40%.
- •Patient is not a candidate for conventional catheter-based or surgical intervention such as valve intervention or coronary artery bypass surgery.
- •Patient is not currently a candidate for heart transplantation or placement of a left ventricular assist device (LVAD) as bridge to heart transplantation due to co-morbidities. Patients may become a candidate for these options if they have improvement on the device due to improved cardiac output.
- •Patients have exhausted all approved surgical and medical therapies as determined by a heart failure cardiologist and a surgeon with expertise in heart failure.
- •Patient has been evaluated by a multi-disciplinary research team and felt to be a suitable candidate for a research study. The final decision regarding the patient's candidacy for research will remain with the attending cardiologist and heart surgeon.
- •Improved hemodynamics on device support will allow for potential for physical rehabilitation.
- •Signed Informed Consent, or oral informed consent with written confirmation by uninvolved third party
- •Age of subject at least 19 years
排除标准
- •High likelihood of death during the current hospitalization (as judged by the attending physician) and condition other than heart failure that would limit survival to less than two years.
- •Require mechanical ventilation.
- •Failure to wean from IABP, Impella, ECMO or other mode of circulatory support.
- •Complex arrhythmias that negatively impact the effectiveness of counter pulsation.
- •Dependency on high dose inotropes.
- •Cerebrovascular accident or TIA within the previous 3 months.
- •Contraindication to anticoagulation medication such as Heparin, Coumadin, Aspirin and Plavix.
- •Presence of hypercoaguable state or history of idiopathic venous or arterial thrombosis.
- •Severe calcification in the target vessel that will preclude insertion of the Symphony device.
- •Moderate to severe aortic insufficiency (2+ or more).
- •Ongoing systemic infection defined as two of the following:
- •WBC > 12,500
- •positive blood culture
- •Abnormal pre-albumin (< 13mg/dL), or albumin (< 3.0 mg/dl)
- •A cardiac rhythm that cannot be used to trigger the CPD (sinus rhythm, ventricular or atrial pacing, A-V pacing).
- •Abnormal bilateral carotid Doppler or CT exam define as > 50% stenosis.
- •Subclavian artery internal diameter of < 7 mm on Doppler study or CT exam.
- •Ability to ambulate < 200 metres on a 6 minute walk test.
- •Any aortic aneurysmal disease.
- •Active documented HIT.
- •Presence of mechanical heart valve.
- •Moderate to severe RV failure.
- •Severe tricuspid regurgitation.
- •History of major psychiatric illness.
- •End-organ dysfunction including:
- •renal failure defined as serum Cr > 2.5 mg/dl,
- •liver dysfunction defined as bilirubin 2X normal, or elevated INR with no anticoagulation,
- •respiratory failure defined as FEV1 < 50% predicted.
- •Chest X-ray to rule out pulmonary pathology that increases the risk of need for treatment prior to device implant.
- •BMI > 40 kg/ m
- •Active participation in another clinical trial that may interfere with this trial.
研究组 & 干预措施
Symphony system
Experimental
干预措施: Symphony (Device)
Symphony system
Experimental
干预措施: The operative approach is limited to an infraclavicular incision similar to that used for placement of a pacemaker (Procedure)
结局指标
主要结局
Death, Stroke or Transient Ischemic Attack (TIA), Limb Ischemia requiring surgical intervention
时间窗: hospital discharge or 30 days of support, whichever is longer
The trial will primarily look at patient safety defined as proportion of composite Major Adverse Events (MAE) up to hospital discharge or 30 days of CPD support, whichever is longer.
次要结局
未报告次要终点
研究者
研究点 (3)
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