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Coronary and Structural Interventions - Transcatheter Aortic Valve Replacement

Coronary and Structural Interventions - Transcatheter Aortic Valve Replacement

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02162069
Acronym
CSI-TAVR
Enrollment
843
Registered
2014-06-12
Start date
2014-06-30
Completion date
2018-12-31
Last updated
2020-04-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aortic Valve Stenosis

Brief summary

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

Detailed description

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

Interventions

DEVICECE certified transcatheter ( aortic valve replacement)

Patients receive a transcatheter aortic valve replacement with CE certified transcatheter aortic valves.

Sponsors

University of Ulm
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

TAVR

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* aortic valve stenosis * transcatheter aortic valve replacement

Exclusion criteria

* no written informed consent

Design outcomes

Primary

MeasureTime frame
Major adverse cerebral and cardiac events.1-5 years

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 12, 2026