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NCT02162069 Clinical Trial

Coronary and Structural Interventions - Transcatheter Aortic Valve Replacement

Aortic Valve Stenosis Clinical Trial

— CSI-TAVR  

Official title:
Coronary and Structural Interventions - Transcatheter Aortic Valve Replacement

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02162069
Other study ID # CSI TAVR 1.0
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 2014
Est. completion date December 2018

Study information
Verified date April 2020
Source University of Ulm
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To evaluate the long-term results after transcatheter aortic valve replacement

Description:

Patients with transcatheter aortic valve replacement are followed for 5 years to demonstrate efficacy and safety.

Recruitment information / eligibility
Status Completed
Enrollment 843
Est. completion date December 2018
Est. primary completion date December 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- aortic valve stenosis

- transcatheter aortic valve replacement

Exclusion Criteria:

- no written informed consent

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• CE certified transcatheter ( aortic valve replacement)
Patients receive a transcatheter aortic valve replacement with CE certified transcatheter aortic valves.

Locations
Country Name City State
Germany University of Ulm Ulm

Sponsors (1)
Lead Sponsor Collaborator
University of Ulm

Country where clinical trial is conducted

Germany, 

References & Publications (2)

Seeger J, Gonska B, Otto M, Rottbauer W, Wöhrle J. Cerebral Embolic Protection During Transcatheter Aortic Valve Replacement Significantly Reduces Death and Stroke Compared With Unprotected Procedures. JACC Cardiovasc Interv. 2017 Nov 27;10(22):2297-2303. doi: 10.1016/j.jcin.2017.06.037. Epub 2017 Sep 13. — View Citation

Seeger J, Kapadia SR, Kodali S, Linke A, Wöhrle J, Haussig S, Makkar R, Mehran R, Rottbauer W, Leon M. Rate of peri-procedural stroke observed with cerebral embolic protection during transcatheter aortic valve replacement: a patient-level propensity-match — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Major adverse cerebral and cardiac events. 1-5 years
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