A feasibility study to assess the safety and efficacy of JenaValve for patients with severe aortic stenosis (AS).
Not Applicable
Suspended
- Conditions
- Aortic StenosisCardiovascular - Other cardiovascular diseases
- Registration Number
- ACTRN12616000717459
- Lead Sponsor
- JenaValve Technology, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Suspended
- Sex
- All
- Target Recruitment
- 30
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method