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Sponsored by: |
Ventor Technologies |
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Information provided by: | Ventor Technologies |
ClinicalTrials.gov Identifier: | NCT00677638 |
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.
Condition | Intervention |
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Aortic Valve Disease |
Device: Ventor Embracer |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Single Group Assignment |
Official Title: | Catheter-Based Transapical Implantation of the Ventor Embracer™ Heart Valve Prosthesis in Patients With Severe Aortic Valve Disease |
Estimated Enrollment: | 30 |
Study Start Date: | June 2008 |
Estimated Study Completion Date: | June 2014 |
Estimated Primary Completion Date: | July 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Embracer implantation
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Device: Ventor Embracer
Implantation of Ventor Embracer
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Ages Eligible for Study: | 75 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Germany | |
Friedrich Mohr, MD | Recruiting |
Leipzig, Germany, 04289 | |
Contact: Friedrich Mohr, Prof. MD +49 3418651421 mohrf@medizin.uni-leipzig.de | |
Sub-Investigator: Friedrich Mohr, Prof. MD | |
Prof. Jochen Schaefers | Recruiting |
Homburg, Germany, 66421 | |
Contact: Jochen H Schafers, Prof. MD +49 (6841) -1632000 chhjsc@uniklinikum-saarland.de | |
Principal Investigator: Jochen H Schafers, Prof. MD |
Principal Investigator: | Jochen Schaefers, MD | Universitatsklinikum des Saarlandes |
Principal Investigator: | Friedrich Mohr, MD | Universität Leipzig |
Responsible Party: | Ventor Technologies ( Sharon Sax ) |
Study ID Numbers: | CLIN004 |
Study First Received: | May 12, 2008 |
Last Updated: | August 31, 2008 |
ClinicalTrials.gov Identifier: | NCT00677638 History of Changes |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |