PERcutaneous heModynamic Support With Impella 2.5 During Scar-related Ventricular Tachycardia Ablation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Number of Participants With Procedural Success
研究概览
简要总结
The purpose of this research study is to evaluate the safety and feasibility of the Impella 2.5 Circulatory Support System for use during mapping and ablation of ventricular tachycardia in the setting of Ventricular dysfunction.
详细描述
The Impella 2.5 is a percutaneous heart pump that will be used to provide partial circulatory support -. The Impella 2.5 is approved by the US Food and Drug Administration and is being tested to see if it helps keep the patient's blood pressure stable during the cardiac ablation procedure. The Impella 2.5 Circulatory Support System works by placing a small pump into the left pumping chamber of the heart which will then help the heart circulate blood throughout the body. The Impella 2.5 Circulatory Support system will be removed once the heart no longer needs help with the pumping action which can be at any time from just after the completion of the heart procedure up to several days post procedure as determined by physician.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •male or female
- •age 18 to 90 years
- •catheter ablation of ventricular tachycardia
- •Left Ventricular ejection fraction less than or equal to 40% or hypertrophic cardiomyopathy
排除标准
- •Any reversible cause of VT [electrolyte derangements, medication related itc]
- •Evidence of active, ongoing cardiac ischemia as the cause of VT
- •Patients who have experienced any cerebral ischemic event including any TIA in the preceding one month
- •Mural thrombus in left Ventricle
- •Presence of mechanical aortic valve
- •Severe Aortic Stenosis [orifice area of 2.0 cm2 or less] or moderate to severe aortic insufficiency
- •Severe abnormalities of the aorta that would preclude Impella insertion, including aneurysms and extreme tortuosity or calcifications
- •Liver dysfunction or markedly abnormal coagulation parameters [as defined by platelet count less than or equal to 50,000/ul]
- •Any condition resulting in contraindication to anticoagulation [eg GI bleeding]
- •Women who are known to be pregnant or have had a positive B-HCG test 7 days prior to procedure
- •Patients whose life expectancy is less than one year
- •Mental Impairment precluding patient or family from providing informed consent or completing the appropriate follow up
结局指标
主要结局
Number of Participants With Procedural Success
时间窗: Inpatient Admission
Satisfactory hemodynamic status during the ablation procedure \[during VT Mapping and Ablation Procedure\], utilizing the Hemodynamic Support of Impella 2.5 Circulatory Support System
次要结局
- Clinical Outcomes(1 Month post ablation Follow up)
研究者
Vivek Reddy
DIRECTOR CARDIAC ARRHYTHMIA SERVICE, PROFESSOR OF MEDICINE
Icahn School of Medicine at Mount Sinai