ISRCTN82621856暂停2 期
Distal ventricular pacing and intraventricular gradient reduction for symptomatic relief in drug-refractory hypertrophic cardiomyopathy patients with mid-cavity obstruction
适应症
试验速览
- 阶段
- 2 期
- 状态
- 暂停
- 入组人数
- 25
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Male or female, >18 years
- •2. Referred for PPM +/- ICD implantation for either primary prevention of sudden cardiac death or other indications such as heart block or obstructive physiology
- •3. HCM patients with a mid-cavity gradient of =30 mmHg demonstrated by echocardiography and morphology confirmed by cardiac MRI. Gradient confirmed by cardiac catheterisation
- •4. All patients should be taking maximum tolerated doses of beta blockers or verapamil with or without disopyramide
- •5. Symptoms refractory to optimum medical therapy as above, for example breathlessness, chest pain, dizziness, or syncope
排除标准
- •1. Patients with multi-level obstruction, i.e. across the mid-cavity and outflow tract
- •2. Patients with moderate or severe valvular stenosis or regurgitation due to primary valvular disease
- •3. Patients with untreated symptomatic coronary disease
- •4. Patients in atrial fibrillation at the time of implantation
- •5. Pregnancy
- •6. Renal failure with eGFR < 20mL/min
- •7. Any patient not suitable in the clinicians opinion
- •8. Any patient who is for whatever reason is not expected for more than one year
- •9. Patients unable to provide informed consent
研究者
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