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NCT03583398 Clinical Trial

Health-related QoL Following TAVI TAo, TAVI TF and AVR

Quality of Life Clinical Trial

Official title:
Health-related Quality of Life Following Transcatheter Aortic Valve Implantation Using Transaortic, Transfemoral Approaches and Surgical Aortic Valve Replacement - a Single-center Study

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03583398
Other study ID # MUGdansk
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 2015
Est. completion date March 2018

Study information
Verified date July 2018
Source Medical University of Gdansk
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The aim of the study was to evaluate short- and long-term changes in QoL in patients undergoing TAVI and to assess differences in patient QoL when using the TAVI TAo approach compared with the transfemoral approach (TAVI TF) and surgical aortic valve replacement (SAVR).

Recruitment information / eligibility
Status Completed
Enrollment 97
Est. completion date March 2018
Est. primary completion date December 2017
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

- aortic valve stenosis

Exclusion Criteria:

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• transcatheter aortic valve implantation, surgical aortic valve replacement
Transcatheter aortic valve implantation using transaortic and transfemoral access and surgical aortic valve replacement.

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
Medical University of Gdansk Institut für Pharmakologie und Präventive Medizin

Outcome
Type Measure Description Time frame Safety issue
Primary Health-related quality of life: EQ-5D-3L questionnaire EQ-5D-3L questionnaire 1 month and 1 year follow-up
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