Cardiac Resynchronization Therapy in Pulmonary Hypertension
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- 15% increase in cardiac output at the optimal VV interval over baseline cardiac output
研究概览
简要总结
This study is being conducted to determine whether patients with advanced pulmonary hypertension when treated with cardiac resynchronization therapy improve hemodynamically and/or receive clinical benefit.
详细描述
This study aims to determine whether stimulating earlier activation of the failing right ventricle in pulmonary hypertension reduces the effects of interventricular dependence in human subjects, thereby improving overall cardiac function and symptoms in patients with pulmonary hypertension and right ventricle failure with NYHA Class 3-4 symptoms.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pulmonary hypertension, defined as pulmonary artery systolic pressure greater than 40 mm Hg by transthoracic echocardiogram or right heart catheterization
- •LVEF ≥ 50%
- •Baseline 6MWT distant <400 meters
- •Baseline NYHA Functional class ≥ III
排除标准
- •LVEF < 50%
- •6MWT duration > 400 meters
- •NYHA Functional class < III
- •Left bundle branch block
- •Non-sinus rhythm
- •Severe aortic stenosis (Aortic valve area < 1 cm2)
- •Severe mitral regurgitation
- •Acute cardiac failure
- •Dependency on intravenous inotropies
- •Severe obstructive pulmonary disease
- •Hypertrophic obstructive cardiomyopathy
- •Amyloidosis
- •Dependence on pacing
研究组 & 干预措施
Arms
Pacing wires used to stimulate ventricles in a synchronous matter
干预措施: Cardiac Resynchronization Therapy (CRT) (Device)
结局指标
主要结局
15% increase in cardiac output at the optimal VV interval over baseline cardiac output
时间窗: the procedure
Primary Outcome
次要结局
未报告次要终点
研究者
Dr. Daniel P Morin, MD MPH FHRS
Cardiac Electrophysiologist
Ochsner Health System