ACTRN12616000717459
Suspended
未知
A Feasibility Study to Assess Safety and Efficacy of the Transapical and Transfemoral JenaValve Pericardial TAVR (Transcatheter Aortic Valve Replacement) System in the Treatment of Patients with Symptomatic Severe Aortic Stenosis (AS)
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Aortic Stenosis
- Sponsor
- JenaValve Technology, Inc.
- Enrollment
- 30
- Status
- Suspended
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\.Patient with severe degenerative native aortic stenosis (AS)
- •2\.Patient at high risk for open surgical valve replacement
- •3\.Patient symptomatic according to NYHA functional class II or higher
Exclusion Criteria
- •1\.Congenital uni\- or bicuspid aortic valve morphology
- •2\.Previous prosthetic aortic valve (bioprosthesis or mechanical) implant
- •3\.Endocarditis or other active infection
- •4\.Need for urgent or emergent TAVR procedure for any reason
- •5\.Cardiogenic shock or hemodynamic instability requiring inotropic support or ventricular assist device
Outcomes
Primary Outcomes
Not specified
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