Surgical Septal Myectomy Versus Percutaneous Transluminal Alcohol Septal Ablation in Patients With Hypertrophic Obstructive Cardiomyopathy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Metabolic Equivalent (METs) assessed with a bicycle ergometry exercise test
研究概览
简要总结
The aim of this randomized trial is to compare the improvement in exercise capacity among patients with highly symptomatic hypertrophic obstructive cardiomyopathy despite optimal medical treatment who undergo alcohol septal ablation (ASA) or surgical septal myectomy (SSM).
详细描述
This is a prospective, multicentre, open label, randomized controlled, non-inferiority trial (RCT) with a 1:1 randomization to alcohol septal ablation or surgical septal myectomy in patients with hypertrophic obstructive cardiomyopathy (HOCM) between 40-75 year of age with symptoms and/or syncope due to HOCM despite medical therapy. A total of 100 patients will be included. All patients will be evaluated with bicycle ergometry exercise test, MRI and 2D-echo before and 1 year after invasive treatment. Follow-up will be at 1,3 and 5 years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 40-75 years including 40 and 75 years of age
- •HOCM eligible for both SSM and ASA by a heart team (multidisciplinary team) and core lab.
- •Left ventricle outflow tract (LVOT) obstruction > 30mmHg at rest or during physiological provocation by transthoracic echocardiogram
- •Symptomatic (New York Heart Association classification (NYHA) >1 or Canadian Cardiovascular Society (CCS) class >1) and/or syncope due to HOCM
排除标准
- •Unable to give informed consent
- •A life expectancy of less than 1 year
- •Concomitant (structural valve disease, aorta, rhythm, CABG) surgery during the same session
- •Not able to perform bicycle ergometry exercise test
结局指标
主要结局
Metabolic Equivalent (METs) assessed with a bicycle ergometry exercise test
时间窗: 1 year after the invasive treatment
The primary endpoint is the improvement of the exercise capacity in the form of Metabolic Equivalent (METs) which will be assessed with a bicycle ergometry exercise test (difference in exercise capacity in Metabolic Equivalents) performed before and 1 year after invasive treatment.
次要结局
- Number of participants with hospital Readmittance(Follow up will be 1,3 and 5 years)
- Number of participants with with complete heart block requiring permanent pacemaker implantation(Follow up will be 1,3 and 5 years)
- Number of participants with re-intervention(Follow up will be 1,3 and 5 years)
- Number of participants with cardiovascular mortality(Follow up will be 1,3 and 5 years)
- Number of participants with ventricular arrhythmias(Follow up will be 1,3 and 5 years)
- Number of participants with all-cause mortality(Follow up will be 1,3 and 5 years)
- Quality of life evaluation using the The Kansas City Cardiomyopathy Questionnaire (KCCQ)(Follow up will be 1,3 and 5 years)
- Number of participants with transient Ischemic Attack(Follow up will be 1,3 and 5 years)
- Number of participants with with occurrence of atrial fibrillation(Follow up will be 1,3 and 5 years)
- Number of participants with major bleeding(First 30 days)
- Blood sample results(Follow up will be 1,3 and 5 years)
- Cardiac Magnetic Resonance Imaging (CMR) parameters(Follow up will be 1,3 and 5 years)
- Transthoracic echocardiogram(Follow up will be 1,3 and 5 years)
研究者
J.M. ten Berg
Clinical Professor
St. Antonius Hospital