What is the Vienna Aortic Valve SE System studying for symptomatic aortic stenosis?

The Vienna Aortic Valve SE System is being studied to evaluate its safety and effectiveness in patients with symptomatic severe aortic stenosis. This clinical trial aims to understand how well the new self-expanding valve works over time and to assess any risks involved. The study is sponsored by P+F Products + Features GmbH.

Who may be eligible for this symptomatic aortic stenosis clinical trial?

Adults aged 65 years or older with severe symptomatic aortic stenosis may be eligible. Both men and women can participate, but women must not be of childbearing potential. Additional requirements include the ability to undergo transcatheter valve implantation and meeting certain heart and vessel health criteria. Please review eligibility criteria for more details.

Is there any cost to participate in this symptomatic aortic stenosis clinical trial?

Study-related care, including the study device and all trial visits, is provided at no cost. However, personal travel expenses may vary and are not guaranteed to be covered by the study. Participants should plan accordingly for any travel or lodging costs.

Actively Recruiting

Phase Not Applicable

Age: 65Years +

All Genders

ID04861805

A Two-Stage First in Human FIH Feasibility and Pivotal Study of the Vienna Aortic Valve SE System for Symptomatic Severe Aortic Stenosis

Led by P+F Products + Features GmbH · Updated on 2025-06-29

267

Participants Needed

Research Sites

260 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating 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. This prospective, single-arm, multicenter trial includes up to 267 patients and follows them for up to five years after valve implantation. The study aims to gather important data beyond an initial feasibility study to better understand this devices performance over time. Participants will receive the Vienna Aortic Valve SE System through a transcatheter aortic valve implantation TAVI procedure. After implantation, patients will have 11 scheduled visits, including follow-ups at 30 days, 3 months, 6 months, 1 year, and annually up to 5 years. These visits allow researchers to monitor the devices safety and effectiveness throughout the study period. During the trial, participants will undergo clinical evaluations including assessments of mortality, valve function, and heart-related events. Quality of life and exercise capacity will also be measured. Monitoring includes checking for complications like bleeding or conduction problems requiring pacemakers. The study concludes after each participant completes their 5-year follow-up visit, providing long-term information on the valve systems outcomes.

CONDITIONS

Brief Title

Pivotal Study of the Vienna Transcatheter Self Expandable Aortic Valve SE System

Who Can Participate

Age: 65Years +

All Genders

Eligibility Criteria

You may qualify if you...

Male or female patients
Age 65 years or older at time of consent
Women of non-childbearing potential
Severe degenerative calcific native aortic valve stenosis with aortic valve area less than 1.0 cm2 or AVA index less than or equal to 0.6 cm2/m2
Jet velocity greater than 4.0 m/s or mean gradient greater than 40 mmHg
Symptomatic aortic stenosis with history of dyspnea (NYHA class II or greater), angina pectoris, or cardiac syncope
Considered at intermediate or high risk for surgical valve replacement based on EuroSCORE II of 4% or more or Heart Team agreement
Eligible for transfemoral transcatheter aortic valve implantation (TAVI) as determined by local Heart Team
Aortic annulus diameter between 18 and 29 mm measured by computed tomography
Adequate iliofemoral vascular access meeting size and calcification criteria
Ability to understand study requirements and provide written informed consent
Agreement to return for all required post-procedure follow-up visits

You will not qualify if you...

Congenital unicuspid or bicuspid aortic valve or non-calcified valves
Acute myocardial infarction within 30 days prior to screening or implantation
Cerebrovascular stroke or transient ischemic attack within 90 days prior to screening or implantation
Hypertrophic obstructive cardiomyopathy
Therapeutic invasive cardiac procedure within 30 days prior to screening or implantation (except pacemaker implantation)
Untreated clinically significant coronary artery disease requiring revascularization
Severe left ventricular dysfunction with ejection fraction less than 20%
Cardiogenic shock or need for mechanical hemodynamic support
Significant conduction abnormalities at screening or implantation
Severe peripheral vascular disease or symptomatic carotid/vertebral disease
Iliofemoral vessel characteristics preventing safe device passage
Active bacterial endocarditis within 6 months prior to screening or implantation
Presence of intra-cardiac mass, thrombus, or vegetation
Pre-existing prosthetic heart valve (except mitral ring)
Severe mitral, aortic, or tricuspid valve regurgitation or mitral stenosis
Need for emergency surgery at time of screening or implantation
Contraindications to bioprosthetic valve placement or antiplatelet therapy
Renal insufficiency with eGFR below 30 ml/min or on renal replacement therapy
Significant pulmonary disease or severe pulmonary hypertension
Active systemic infection or sepsis
Known hypersensitivity or contraindication to contrast media or device materials
Blood disorders or recent gastrointestinal bleeding
Refusal of blood transfusions
Life expectancy less than 12 months due to non-cardiac conditions
Pregnancy or breastfeeding
Severe dementia affecting consent or follow-up
Other medical, social, or psychological conditions preventing adherence
Participation in another investigational drug or device study not completed

Research Team

Katharina Kiss, Dr

Monica Tocchi, MD, PhD

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