Quality of LifeNCT03583398
Health-related QoL Following TAVI TAo, TAVI TF and AVR
An observational study of Quality of Life, run by Medical University of Gdansk.
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). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Quality of Life
- What is being tested?
- transcatheter aortic valve implantation, surgical aortic valve replacement
- Type of treatment
- Surgery or procedure
- How many people
- 97 participants
- Where
- No sites listed yet
- Study dates
- Jan 2015to Mar 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Elderly population with aortic valve stenosis.
Who may be able to join
- aortic valve stenosis
Who cannot join
- -
About this study
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
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).
- Conditions
- Quality of Life
- Being tested
- transcatheter aortic valve implantation, surgical aortic valve replacement
- Keywords
- TAVI, quality of life, SAVR
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcatheter aortic valve implantation, surgical aortic valve replacementProcedure or surgery
Transcatheter aortic valve implantation using transaortic and transfemoral access and surgical aortic valve replacement.
| Study group | Role | What they receive |
|---|---|---|
| TAVI TAo | Not described Receives: Procedure: transcatheter aortic valve implantation, surgical aortic valve replacement | |
| TAVI TF | Not described Receives: Procedure: transcatheter aortic valve implantation, surgical aortic valve replacement | |
| AVR | Not described Receives: Procedure: transcatheter aortic valve implantation, surgical aortic valve replacement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health-related quality of life: EQ-5D-3L questionnaire
EQ-5D-3L questionnaire
Measured: 1 month and 1 year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2018
- Study startJan 2015
- Primary completionDec 2017
- Study completionMar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Quality of LifeStudies of the same condition, open and under way.
- More trials run by Medical University of GdanskThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Gdansk
- Sponsor type
- University, hospital or other
- Collaborators
- Institut für Pharmakologie und Präventive Medizin
- Responsible party
- Principal investigator, Aleksandra Stańska, Medical University of Gdansk
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03583398
- Sponsor's protocol ID
- MUGdansk
- Status last verified
- Jul 2018
- First submitted
- 28 Jun 2018
- Last updated
- 12 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03583398
- Acronym / sponsor ID
- MUGdansk
- Conditions
- Quality of Life
- Keywords
- TAVI, quality of life, SAVR
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- Medical University of GdanskUniversity, hospital or other
- Collaborators
- Institut für Pharmakologie und Präventive Medizin
- Study start
- Jan 2015 (actual)
- Primary completion
- Dec 2017 (actual)
- Study completion
- Mar 2018 (actual)
- First posted
- 11 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| TAVI TAo | – | Procedure: transcatheter aortic valve implantation, surgical aortic valve replacement |
| TAVI TF | – | Procedure: transcatheter aortic valve implantation, surgical aortic valve replacement |
| AVR | – | Procedure: transcatheter aortic valve implantation, surgical aortic valve replacement |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Elderly population with aortic valve stenosis.
Key inclusion criteria (1 listed)
- aortic valve stenosis
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| transcatheter aortic valve implantation, surgical aortic valve replacementTranscatheter aortic valve implantation using transaortic and transfemoral access and surgical aortic valve replacement. | Procedure or surgery | AVR, TAVI TAo, TAVI TF |
Primary outcome
Health-related quality of life: EQ-5D-3L questionnaire
Time frame: 1 month and 1 year follow-up
EQ-5D-3L questionnaire
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Quality of Life, run by Medical University of Gdansk.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health-related quality of life: EQ-5D-3L questionnaire (time frame: 1 month and 1 year follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2018.