NCT05672160

Brief 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?

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
930

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2022

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2023

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 2, 2023

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

January 3, 2023

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 5, 2023

Completed
Last Updated

January 5, 2023

Status Verified

January 1, 2023

Enrollment Period

1 year

First QC Date

January 3, 2023

Last Update Submit

January 3, 2023

Conditions

SarcopeniaAortic Valve Stenosis

Keywords

sarcopeniasurvivalTAVI

Outcome Measures

Primary Outcomes (1)

  • Overal survival

    Time from the TAVI procedure to death

    11 years

Interventions

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.

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The patients indicated for TAVI procedure because of the critical aortic valve stenosis.

You may qualify if:

  • patients udergone TAVI procedure

You may not qualify if:

  • patients with incomplete TAVI procedure, patients without clinical follow up

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AGELTrinecPodlesi

Třinec, Česká Republika, 73961, Czechia

Location

MeSH Terms

Conditions

SarcopeniaAortic Valve Stenosis

Condition Hierarchy (Ancestors)

Muscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and SymptomsAortic Valve DiseaseHeart Valve DiseasesHeart DiseasesCardiovascular DiseasesVentricular Outflow Obstruction

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Mr. Matej Pekar, MD, PhD

Study Record Dates

First Submitted

January 3, 2023

First Posted

January 5, 2023

Study Start

January 1, 2022

Primary Completion

January 1, 2023

Study Completion

January 2, 2023

Last Updated

January 5, 2023

Record last verified: 2023-01

Locations

CZ(1)