Transapical Implantation of Ventor Embracer™ Valve in Patients With Severe Aortic Valve Disease
NCT00677638 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30
Last updated 2009-12-03
Summary
A prospective single arm study evaluating feasibility and safety of a catheter-based transapical implantation of the Ventor Embracer™ aortic valve bioprosthesis in patients with severe aortic valve disease, specifically aortic stenosis, who are at elevated risk for standard surgical valve replacement.
Conditions
- Aortic Valve Disease
Interventions
- DEVICE
-
Ventor Embracer
Implantation of Ventor Embracer
Sponsors & Collaborators
-
Ventor Technologies
lead INDUSTRY
Principal Investigators
-
Jochen Schaefers, MD · Universitatsklinikum des Saarlandes
-
Friedrich Mohr, MD · Universität Leipzig
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2008-06-30
- Primary Completion
- 2010-01-31
- Completion
- 2014-12-31
Countries
- Germany
Study Locations
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