Safety and Efficacy Study of the Cardiapex Percutaneous Trans-apical Access and Closure System
NCT01722591 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 38
Last updated 2015-02-04
Summary
A prospective, multicenter, uncontrolled study to evaluate the safety and efficacy of the Cardiapex percutaneous trans-apical access and closure system. The Cardiapex device intended for percutaneous access and closure of the left ventricular apex in conjunction with transapical Transcatheter Aortic Valve Implantation (TAVI).
Conditions
- Transapical Transcatheter Aortic Valve Implantation
Interventions
- DEVICE
-
Cardiapex device
Cardiapex percutaneous transapical access and closure system
Sponsors & Collaborators
-
Cardiapex Ltd.
lead INDUSTRY
Study Design
- Allocation
- NA
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2013-01-31
- Primary Completion
- 2014-02-28
Countries
- Germany
Study Locations
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