Coronary and Structural Interventions - Transcatheter Aortic Valve Replacement

Not Applicable

Completed

• Conditions: Aortic Valve Stenosis
• Interventions: Device: CE certified transcatheter ( aortic valve replacement)

• Registration Number: NCT02162069
• Lead Sponsor: University of Ulm

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.

Study Timeline

• Study Start: 2014-06
• Study First Submitted: 2014-06-07
• Study First Submitted QC: 2014-06-11
• Study First Posted: 2014-06-12
• Primary Completion: 2018-12
• Study Completion: 2018-12
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-25
• Last Update Posted: 2020-04-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 843

Inclusion Criteria

• aortic valve stenosis
• transcatheter aortic valve replacement

Exclusion Criteria

• no written informed consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
transcatheter aortic valve replacement	CE certified transcatheter ( aortic valve replacement)	Patients receive transcatheter aortic valve replacement.

Primary Outcome Measures

Name	Time	Method
Major adverse cerebral and cardiac events.	1-5 years

Trial Locations

Locations (1)

University of Ulm; 🇩🇪 Ulm, Germany