CTRI/2025/10/096465
尚未招募
不适用
A Two -Stage First in Human (FIH) Feasibility / Pivotal Study of the Vienna Aortic Valve SE System
概览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 267
- 试验地点
- 2
- 主要终点
- All-cause mortality at 30 days from the index procedure.
概览
简要总结
The purpose of this trial is to determine the safety and effectiveness of the Vienna Aortic Valve SE System, a new self-expanding transcatheter heart valve, in patients with symptomatic severe aortic stenosis (SSAS). This is a prospective, single arm, multicenter study in an expanding cohort of symptomatic patients with severe aortic stenosis following the FIH feasibility study. The clinical investigation comprises 11 visits (V1 to V11). After implantation of the IMD at visit 2, safety and effectiveness assessment of the device will be performed at 30 days (V4), 3 months (V5), 6 months (V6), 1 year (V7) and every year thereafter up to 5 years post-implantation (V8 to V11).
In summary, the clinical investigation for the individual patient will end after 5 years with a full clinical evaluation. The primary study endpoints for safety and effectiveness will be reached at 30-day follow-up timepoint.
The clinical trial is completed after all 267 patients, that are not prematurely withdrawn, have completed their 5-year follow-up visit involving all specified assessments.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 65.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Male or Female.
- •2.Age greater than or equal to 65 years at time of consent.
- •3.Women of non-childbearing potential.
- •4.Severe degenerative calcific native aortic valve stenosis with the following criteria assessed either by resting or dobutamine stress TTE: a.
- •Aortic valve area (AVA) less than 1.0 cm2 or AVA index less than or equal to 0.6 cm2/m2 and b.
- •Jet velocity greater than4.0 m/s or mean gradient greater than 40 mmHg 5.Symptomatic aortic stenosis (AS), defined as a history of at least one of the following: a.
- •Dyspnoea that qualifies at NYHA class II or greater b.
- •Angina pectoris c.
- •Cardiac syncope 6.Subject is considered at intermediate or high risk for surgical valve replacement based on at least one of the following: a.
- •EuroSCORE II greater than or equal to 4 percentage along with assessment of frailty, major organ system dysfunction, and procedure-specific impediments, in accordance with scientific guidelines b.
排除标准
- •Cardiovascular System
- •Patient has a congenital unicuspid or bicuspid aortic valve or non-calcified valves.
- •Evidence of an acute myocardial infarction (MI) less than or equal to 30 days prior to screening or IMD implantation (defined as Q-wave MI or non Q-wave MI with total CK elevation greater than or equal to twice normal in the presence of CK-MB elevation and/or troponin elevation).
- •Patient has had a cerebrovascular stroke or TIA within the past 90 days prior to screening or valve implantation.
- •Patient has a hypertrophic obstructive cardiomyopathy.
- •History of any therapeutic invasive cardiac procedure (including balloon aortic valvuloplasty) within 30 days prior to screening or IMD implantation (except for pacemaker implantation which is allowed).
- •Untreated clinically significant coronary artery disease requiring revascularization at the screening visit.
- •Severe left ventricular dysfunction with left ventricular ejection fraction (LVEF) less than 20% by echocardiography, contrast ventriculography, or radionuclide ventriculography.
- •Patient with cardiogenic shock manifested by low cardiac output and hemodynamic instability and vasopressor dependence, or mechanical hemodynamic support.
- •Patients with clinically significant conduction abnormalities (clinically significant sinus bradycardia, sinus block or pauses, clinically significant atrioventricular (AV)-block greater than I) at screening and at time of IMD implantation.
结局指标
主要结局
All-cause mortality at 30 days from the index procedure.
时间窗: All-cause mortality at 30 days from the index procedure.
次要结局
- All-cause, cardiovascular and non-cardiovascular mortality at 30 days, 3 months, 6 months, 1 year and every year thereafter up to 5 years post-implantation.(up to 5 years)
- Incidence of peri-procedural death (to capture intra-procedural events that result in immediate or consequent death less than or equal to 72 h post-procedure)(up to 72 hours)
- Life-threatening bleeding (at 30 days, 3 months, 6 months and 1year post-implantation)(up to 1 year)
- Conduction disturbances requiring permanent pacemaker implantation (at 30 days, 3 months, 6 months, 1 year and every year thereafter up to 5 years post-implantation)(up to 5 years)
- Re-hospitalization for valve-related complications or worsening congestive heart failure (at 30 days, 3 months, 6 months, 1 year and every year thereafter up to 5 years post-implantation)(up to 5 years)
- Device success defined as:(a. correct positioning of a single prosthetic investigational heart valve in the proper anatomical location AND ability to provide appropriate hemodynamic AND absence of peri-procedural mortality within 72 hours after implantation)
- Technical success defined as(1. successful vascular access, delivery and deployment of the IMD and successful retrieval of the delivery system; and)
- Clinical efficacy (at 1 year and thereafter)(1. Freedom from all-cause mortality)
- Valve-related clinical efficacy(1. Freedom from bioprosthetic Valve Failure (defined as: Valve-related mortality OR Aortic valve re-operation/re-intervention OR Stage 3 haemodynamic valve deterioration))
- Change in heart failure symptoms from baseline as assessed by the New York Heart Association (NYHA) classification (at 30 days, 3 months, 6 months, 1 year and every year thereafter up to 5 years post-implantation)(up to 5 years)
- Scale from 0 to 100 and summarized in 25-point ranges, where scores represent health status as follows: 0 to 24: very poor to poor; 25 to 49: poor to fair; 50 to 74: fair to good; and 75 to 100: good to excellent(1 year)
- Change in exercise capacity from baseline measured as the 6-minute walk distance (6-MWD) (at 30 days, 3 months, 6 months and 1 year post-implantation)(1 year)
- Cerebrovascular event (at 30 days, 3 months, 6 months, 1 year and every year thereafter up to 5 years post-implantation):(1. Stroke, defined as an acute episode of focal or global neurological dysfunction caused by the brain, spinal cord, or retinal vascular injury as a result of haemorrhage or infarction)
研究者
Dr Prabhakar Kolamuri
Techsol Life Sciences Private Limited,
研究点 (2)
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