ACTRN12626000799358进行中（未招募）不适用
Prospective, Multicentre, First in Human (FIH) Study of the Shockwave Medical Valvular Transcatheter Lithotripsy II (VTL II) System for the Treatment of Symptomatic Severe Calcified Mitral Stenosis.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 No limit（—）
- 性别
- All
入选标准
- •Subjects are required to meet all of the following inclusion criteria in order to be enrolled in the study:
- •Age is greater than or equal to 18 years
- •Subjects diagnosed with symptomatic severe, calcified mitral stenosis defined as Mitral Valve Area (MVA) is less than or equal to 1.5cm squared, Mean Gradient greater than or equal to 8mmHg or mitral valve diastolic pressure half time less than or equal to 150ms
- •Primary investigator and heart team agrees that the subject is indicated for TMVL treatment
- •Symptomatic calcified mitral valve stenosis with New York Heart Association (NYHA) class greater than or equal to 2
- •Native mitral valve
- •Subject is able and willing to comply with all assessments in the study
- •Subject has been informed of the nature of the study, agrees to participate and has signed the approved consent form
- •Subject eligibility approved by Physician Screening Committee
排除标准
- •Subjects who meet any of the following exclusion criteria may not be enrolled in the study:
- •Subject has other medical, social, or psychological problems that, in the opinion of the investigator, preclude them from receiving this treatment, and the procedures and evaluations pre- and post-treatment, or impact the scientific soundness of the clinical investigation result
- •Co-morbid conditions that, in the opinion of the investigator, limit life expectancy to less than 1 year
- •Rheumatic heart disease
- •Mitral valve regurgitation greater than 1 plus (Mild)
- •Prior mitral valve intervention or surgery at any timepoint, cardiovascular surgery, or carotid surgery within 90 days prior to the index procedure
- •Severe Chronic Obstructive Pulmonary Disease (COPD) defined as forced expiratory volume (FEV1) of less than 750cc, continuous home oxygen, or chronic systemic outpatient steroid use
- •Severe pulmonary hypertension with a fixed pulmonary artery systolic pressure (PASP) greater than 70mmHg
- •Inferior Vena Cava (IVC) filter that would interfere with delivery of catheter
- •Left ventricular ejection fraction (LVEF) less than 30 percent
- •Myocardial infarction within 30 days [defines as Fourth Universal Definition of MI] prior to the index procedure
- •History of significant arrhythmia requiring hospitalisation within 30 days prior to the index procedure
- •Stroke or neurological signs and symptoms attributed to carotid or vertebrobasilar disease within 90 days prior to the index procedure
- •Subject has acute or chronic renal disease with eGRF less than 30ml/min/1.73m squared (using CKD-EPI formula) or is on any form of dialysis
- •History of or active endocarditis
- •Active infection
- •Liver failure (Child-Pugh-C)
- •Need for emergency surgery of any reason within 30 days prior to the index procedure
- •Leukopenia (WBC less than 2000 cells/mL), anaemia (Hgb less than 9g/dL), thrombocytopenia (platelet less than 100,000 cells/mL), history of bleeding diathesis or coagulopathy, hypercoagulable states, or subject refuses blood/blood product transfusion
- •Inability to tolerate, or precluding condition, treatment with anticoagulant therapy
- •Hospitalisation for heart failure within 30 days prior to the index procedure
- •Planned endovascular or surgical procedures within 30 days prior to or following the index procedure
- •Untreated, clinically significant CAD or PCI within 30 days prior to the index procedure
- •Need for aortic, tricuspid, or pulmonary valve intervention within 123 months following index procedure
- •Severe Tricuspid Regurgitation (TR) greater than or equal to 4 plus or severe aortic stenosis
- •evidence of intracardiac mass, thrombus, or vegetation
- •Subject is contraindicated for Transoesophageal echocardiography (TOE) or mitral valve anatomy not fully evaluable by TTE and TOE
- •Subjects with hypertrophic cardiomyopathy (HCM), restrictive cardiomyopathy, or infiltrative cardiomyopathy
- •Subjects with refractory heart failure (Stage D) requiring advanced interventi9o0n (LVAD, transplant)
- •Haemodynamic or respiratory instability requiring inotropic or mechanical support within 30 days prior to the index procedure
- •Subject is pregnant or breastfeeding
- •Subject is participating in another research study involving an investigational agent (pharmaceutical, biologic, or medical device) that has not reached the primary endpoint
- •Active COVID-19 or prev
研究者
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