SarcopeniaTAVI_SarxNCT05672160
Overal Survival After TAVI According to Sarcopenia
An observational study of Sarcopenia and Aortic Valve Stenosis, run by Nemocnice AGEL Trinec-Podlesi a.s. at 1 site in Czechia.
Trial summary
The goal of this observational study is to compare the overal survival after transcatheter aortic valve implantation (TAVI) according to sarcopenia status evaluated from preprocedural CT scans. The main question it aims to answer is: Is CT evaluated sarcopenia an independent predictor of overal survival after TAVI? Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Sarcopenia, Aortic Valve Stenosis
- What is being tested?
- CT evaluated sarcopenia
- How many people
- 930 participants
- Where
- 1 siteCzechia
- Study dates
- 1 Jan 2022to 2 Jan 2023
- 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: The patients indicated for TAVI procedure because of the critical aortic valve stenosis.
Who may be able to join
- patients udergone TAVI procedure
Who cannot join
- patients with incomplete TAVI procedure, patients without clinical follow up
Trial locations and contacts
1 site in 1 country.
About this study
Official title: CT Evaluated Sarcopenia Independently Predicts the Overal Survival After Transcatheter Aortic Valve Implantation
The goal of this observational study is to compare the overal survival after transcatheter aortic valve implantation (TAVI) according to sarcopenia status evaluated from preprocedural CT scans.
The main question it aims to answer is:
- Is CT evaluated sarcopenia an independent predictor of overal survival after TAVI?
Read the detailed description
The patients suffering from aortic valve stenosis, that are not eligible for cardiosurgery were indicated to miniinvasive transcatheter aortic valve implantation (TAVI). The follow up of 930 patients were done in time interval from 1 to 11 years. In every patient the preprocedural CT scans were done. From these CT scans the L3 cross sections will be used for sarcopenia evaluation. Then we will statisticaly evaluate the overal survival after TAVI procedure in the relation with sarcopenia status. We will answer the main question: Is CT evaluated sarcopenia an independent predictor of overal survival after TAVI?
- Conditions
- Sarcopenia, Aortic Valve Stenosis
- Being tested
- CT evaluated sarcopenia
- Keywords
- sarcopenia, survival, TAVI
- Medical subject headings
- Sarcopenia, Aortic Valve Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT evaluated sarcopeniaDiagnostic test
At L3 level of CT scan we will measure the area and density of muscles and fat tissue. We devided the patients to sarcopenia and non-sarcopenia groups according to these values.
What is being measured
The primary outcome is the main question the study is designed to answer.
Overal survival
Time from the TAVI procedure to death
Measured: 11 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2023
- Study start1 Jan 2022
- Primary completion1 Jan 2023
- Study completion2 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcopeniaStudies of the same condition, open and under way.
- 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
- Retrospective
- Enrolment
- 930 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nemocnice AGEL Trinec-Podlesi a.s.
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matej Pekar, MD, PhD, Nemocnice AGEL Trinec-Podlesi a.s.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05672160
- Sponsor's protocol ID
- TAVI_Sarx
- Acronym
- TAVI_Sarx
- Status last verified
- Jan 2023
- First submitted
- 3 Jan 2023
- Last updated
- 5 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CT Evaluated Sarcopenia Independently Predicts the Overal Survival After Transcatheter Aortic Valve Implantation
- ClinicalTrials.gov ID
- NCT05672160
- Acronym / sponsor ID
- TAVI_Sarx / TAVI_Sarx
- Conditions
- Sarcopenia, Aortic Valve Stenosis
- Keywords
- sarcopenia, survival, TAVI
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 930 participants (actual)
- Lead sponsor
- Nemocnice AGEL Trinec-Podlesi a.s.University, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 1 Jan 2023 (actual)
- Study completion
- 2 Jan 2023 (actual)
- First posted
- 5 Jan 2023 (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 goal of this observational study is to compare the overal survival after transcatheter aortic valve implantation (TAVI) according to sarcopenia status evaluated from preprocedural CT scans.
The main question it aims to answer is:
- Is CT evaluated sarcopenia an independent predictor of overal survival after TAVI?
Detailed description
The patients suffering from aortic valve stenosis, that are not eligible for cardiosurgery were indicated to miniinvasive transcatheter aortic valve implantation (TAVI). The follow up of 930 patients were done in time interval from 1 to 11 years. In every patient the preprocedural CT scans were done. From these CT scans the L3 cross sections will be used for sarcopenia evaluation. Then we will statisticaly evaluate the overal survival after TAVI procedure in the relation with sarcopenia status. We will answer the main question: Is CT evaluated sarcopenia an independent predictor of overal survival after TAVI?
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The patients indicated for TAVI procedure because of the critical aortic valve stenosis.
Key inclusion criteria (1 listed)
- patients udergone TAVI procedure
Key exclusion criteria (1 listed)
- patients with incomplete TAVI procedure, patients without clinical follow up
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 |
|---|---|---|
| CT evaluated sarcopeniaAt L3 level of CT scan we will measure the area and density of muscles and fat tissue. We devided the patients to sarcopenia and non-sarcopenia groups according to these values. | Diagnostic test | – |
Primary outcome
Overal survival
Time frame: 11 years
Time from the TAVI procedure to death
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 5 Jan 2023.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sarcopenia and Aortic Valve Stenosis, run by Nemocnice AGEL Trinec-Podlesi a.s. at 1 site in Czechia.
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 5 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Overal survival (time frame: 11 years). 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 5 Jan 2023.