- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03583398
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
|
Transcatheter aortic valve implantation using transaortic and transfemoral access and surgical aortic valve replacement.
|
TAVI TF
|
Transcatheter aortic valve implantation using transaortic and transfemoral access and surgical aortic valve replacement.
|
AVR
|
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
Collaborators
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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