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

July 11, 2018 updated by: Aleksandra Stańska, Medical University of Gdansk

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

97

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Elderly population with aortic valve stenosis.

Description

Inclusion Criteria:

  • aortic valve stenosis

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
TAVI TAo
Procedure: transcatheter aortic valve implantation, surgical aortic valve replacement
Transcatheter aortic valve implantation using transaortic and transfemoral access and surgical aortic valve replacement.
TAVI TF
Procedure: transcatheter aortic valve implantation, surgical aortic valve replacement
Transcatheter aortic valve implantation using transaortic and transfemoral access and surgical aortic valve replacement.
AVR
Procedure: transcatheter aortic valve implantation, surgical aortic valve replacement
Transcatheter aortic valve implantation using transaortic and transfemoral access and surgical aortic valve replacement.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Health-related quality of life: EQ-5D-3L questionnaire
Time Frame: 1 month and 1 year follow-up
EQ-5D-3L questionnaire
1 month and 1 year follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Gdansk

Collaborators

Institut für Pharmakologie und Präventive Medizin

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2015

Primary Completion (Actual)

December 1, 2017

Study Completion (Actual)

March 1, 2018

Study Registration Dates

First Submitted

June 28, 2018

First Submitted That Met QC Criteria

July 10, 2018

First Posted (Actual)

July 11, 2018

Study Record Updates

Last Update Posted (Actual)

July 12, 2018

Last Update Submitted That Met QC Criteria

July 11, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • MUGdansk

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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