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临床试验/CTRI/2025/10/096465
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

P+F Products + Features GmbH2 个研究点 分布在 1 个国家目标入组 267 人开始时间: 2025年11月10日最近更新:
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试验速览

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.
研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

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The clinical trial is completed after all 267 patients, that are not prematurely withdrawn, have completed their 5-year follow-up visit involving all specified assessments.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.
  • •Agreement by the Heart Team that subject is at moderate to high operative risk of serious morbidity or mortality with surgical valve replacement.
  • •7.The local Heart Team deems the patient to be eligible for transfemoral TAVI.
  • •8.Perimeter-based aortic annulus diameter between greater than or equal to18 and less than or equal to 29 mm measured by computed tomography (CT) analyzed by a core lab.
  • •9.Adequate iliofemoral access with either: a.
  • •At least one side with minimum vessel diameter greater than equal to6.0 mm and acceptable level of vessel calcification and tortuosity for safe placement of the introducer sheath, as analyzed by a core lab, OR b.
  • •At least one side with minimum vessel diameter greater than or equal to 5.5 and no significant calcification or severe tortuosity for safe placement of the introducer sheath, as analyzed by a core lab.
  • •10.Patient (or legal representative) understands the study requirements and the treatment procedures and provides written informed consent.
  • •11.The patient and the treating physician agree that the patient will return for all required post-procedure follow-up visits.

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.
  • •Patient has severe peripheral vascular disease: a.
  • •including aortic aneurysm defined as maximal luminal diameter greater than 5 cm or with documented presence of thrombus, marked tortuosity, narrowing of the abdominal aorta, severe unfolding of the thoracic aorta or thick [greater than 5 mm], protruding or ulcerated atheroma in the aortic arch) or b.
  • •symptomatic carotid or vertebral disease or successful treatment of carotid stenosis within 30 days prior to screening or IMD implantation.
  • •Patient with iliofemoral vessel characteristics that would preclude safe passage of the introducer (both sides), as analyzed by a core lab: a.
  • •severe calcification, b.
  • •severe tortuosity (greater than two 90-degree bends), c.
  • •diameter less than 6 mm, in patients with acceptable levels of calcification and acceptable levels of tortuosity d.
  • •diameter less than 5.5, in patients with no calcification and no significant tortuosity, OR e.
  • •subject has had an aorto-femoral bypass
  • •Patient with active bacterial endocarditis within 6 months prior to screening or IMD implantation.
  • •Patient has (echocardiographic/ CT and/or MRI) evidence of intra-cardiac mass, thrombus or vegetation.
  • •Patient has a pre-existing prosthetic heart valve in any position (Note: mitral ring is not an exclusion).
  • •Patient has severe mitral regurgitation, severe aortic regurgitation or severe tricuspid regurgitation, moderate or severe mitral stenosis.
  • •Patient has a need for emergency surgery for any reason at time of screening or IMD implantation.
  • •Any condition considered a contraindication for placement of a bioprosthetic valve (e.g., patient with contraindication to oral antiplatelet therapy).
  • •Patient with renal insufficiency (eGFR less than 30 ml/min per the Cockcroft-Gault formula) and/ or renal replacement therapy and/ or has serum creatinine level greater than 3.0 mg/dL or 265 µmol/L replacement therapy at the time of screening.
  • •Patient with significant pulmonary disease (FEV1 less than 30%) or currently on home oxygen.
  • •Severe pulmonary hypertension (e.g., pulmonary artery systolic pressure greater than or equal to 60 mmHg)
  • •Patients with evidence of an active systemic infection or sepsis.
  • •Patient has a known hypersensitivity or contraindication to contrast media, bovine tissue, nitinol (titanium or nickel), contraindication to oral antiplatelet therapy (aspirin, ticlopidine or clopidogrel) or heparin.
  • •Patient has a haemoglobin less than 9 g/dL, platelet count less than 50,000 cells/mm3 or greater than 700.000 cells/mm3, or white blood cell count less than 1.000 cells/mm3, or history of bleeding diathesis or coagulopathy.
  • •Patient has peptic ulcer disease or history of gastrointestinal bleeding within the 3 months prior to screening or IMD implantation.
  • •Patient refuses blood transfusions.
  • •Patient has a life expectancy of less than 12 months due to non cardiac, co-morbid conditions based on the assessment of the investigator at the time of enrolment (i.e. the time of informed consent).
  • •Patient is pregnant or breast feeding.
  • •Severe dementia (resulting in either inability to provide informed consent for the study/procedure, prevents independent lifestyle outside of a chronic care facility, or will fundamentally complicate rehabilitation from the procedure or compliance with follow-up visits).
  • •Other medical, social, or psychological conditions that in the opinion of the Investigator precludes the patient from appropriate consent or adherence to the protocol required follow-up exams.
  • •Patient is currently participating in another investigational drug or device study that has not reached its primary endpoint (excluding observational studies).

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

申办方类型
Pharmaceutical industry-Global
责任方
Principal Investigator
主要研究者

Dr Prabhakar Kolamuri

Techsol Life Sciences Private Limited,

研究点 (2)

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