Safety and Efficacy Study of the Cardiapex Percutaneous Trans-apical Access and Closure System
NCT ID: NCT01722591
Last Updated: 2015-02-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
38 participants
INTERVENTIONAL
2013-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
NONE
Study Groups
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Cardiapex device
Use of the Cardiapex device in the context of transapical TAVI procedures
Cardiapex device
Cardiapex percutaneous transapical access and closure system
Interventions
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Cardiapex device
Cardiapex percutaneous transapical access and closure system
Eligibility Criteria
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Inclusion Criteria
* Patient ≥ 70 years of age
* Patient able to give informed written consent
* Patient able to attend follow up examinations
Exclusion Criteria
* Patient with Left Ventricular Ejection Fraction (LVEF) \< 30% at time of enrollment
* Patient with known apical infarcted area
* Patient with a distinct large vessel right at the anatomical apex9 (based on pre-operative coronary angiography
* Patients with known lung tissue surrounding the apex and possibly interfering with the in-out puncture (based on preoperative gated CT assessment
* Patient with contra-indications to transapical TAVI
* Patient's inability to tolerate or comply with normal post-surgical drug regimen
* Patient's inability to comply with required follow-ups, including echocardiography
* Patient participation in other clinical trials within previous month
70 Years
ALL
No
Sponsors
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Cardiapex Ltd.
INDUSTRY
Responsible Party
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Locations
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Kerckhoff Clinic
Bad Nauheim, , Germany
Hamburg University Heart Center
Hamburg, , Germany
Countries
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Other Identifiers
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CLN-PRO-01
Identifier Type: -
Identifier Source: org_study_id
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