- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05672160
Overal Survival After TAVI According to Sarcopenia (TAVI_Sarx)
January 3, 2023 updated by: Matej Pekar, MD, PhD, Nemocnice AGEL Trinec-Podlesi a.s.
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?
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Actual)
930
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Česká Republika
-
Třinec, Česká Republika, Czechia, 73961
- AGELTrinecPodlesi
-
-
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
The patients indicated for TAVI procedure because of the critical aortic valve stenosis.
Description
Inclusion Criteria:
- patients udergone TAVI procedure
Exclusion Criteria:
- patients with incomplete TAVI procedure, patients without clinical follow up
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
- Observational Models: Cohort
- Time Perspectives: Retrospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overal survival
Time Frame: 11 years
|
Time from the TAVI procedure to death
|
11 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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, 2022
Primary Completion (Actual)
January 1, 2023
Study Completion (Actual)
January 2, 2023
Study Registration Dates
First Submitted
January 3, 2023
First Submitted That Met QC Criteria
January 3, 2023
First Posted (Actual)
January 5, 2023
Study Record Updates
Last Update Posted (Actual)
January 5, 2023
Last Update Submitted That Met QC Criteria
January 3, 2023
Last Verified
January 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- TAVI_Sarx
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
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.
Clinical Trials on Aortic Valve Stenosis
-
Anteris Technologies Ltd.Active, not recruitingAortic Stenosis | Aortic Valve Calcification | Severe Aortic Valve Stenosis | Symptomatic Aortic StenosisUnited States
-
The Medicines CompanyCompletedTranscatheter Aortic Valve Replacement | Aortic Valve Replacement | Severe Aortic StenosisNetherlands, Germany, United Kingdom, Canada, France, Italy, Switzerland
-
Ningbo Jenscare Biotechnology Co., Ltd.UnknownAortic Regurgitation | Severe Aortic Stenosis
-
Anteris Technologies Ltd.Active, not recruitingAortic Valve Calcification | Severe Aortic Valve Stenosis | Symptomatic Aortic StenosisGeorgia
-
Edwards LifesciencesCompletedAortic Valve Stenosis | Aortic Valve Stenosis With Insufficiency | Regurgitation, Aortic Valve | Aortic Valve IncompetenceUnited States
-
Sorin Group USA, Inc.TerminatedAortic Valve Stenosis | Aortic Valve Stenosis With Insufficiency | Regurgitation, Aortic Valve | Aortic Valve IncompetenceUnited States
-
Edwards LifesciencesActive, not recruitingAortic Stenosis | Aortic Regurgitation | Symptomatic Aortic StenosisChina
-
Hospices Civils de LyonRecruiting
-
Edwards LifesciencesCompletedAortic Stenosis | Aortic Regurgitation | Symptomatic Aortic StenosisChina
-
Genesis Medtech CorporationRecruitingDiseases of Aortic Valve | Aortic Stenosis DiseaseChina
Clinical Trials on CT evaluated sarcopenia
-
Institut BergoniéRecruiting
-
CHU de ReimsUnknownPancreatic Cancer | Malnutrition | Sarcopenia | Liver CancerFrance
-
University Hospital, Clermont-FerrandCompleted
-
Far Eastern Memorial HospitalCompletedSarcopenia | COPD ExacerbationTaiwan
-
Brugmann University HospitalCompleted
-
WepromRecruitingSarcopenia | Cancer of Head and Neck | CT ScanFrance
-
Universidade do AlgarveEuropean Regional Development FundCompletedFrailty | Sarcopenia | Sarcopenic ObesityPortugal
-
WepromCompletedMetastatic CancerFrance
-
Wirral University Teaching Hospital NHS TrustUnknownEmergencies | Frailty | SurgeryUnited Kingdom
-
Herlev and Gentofte HospitalBispebjerg HospitalRecruitingSarcopenia | Muscle Loss | Fall PatientsDenmark