Overal Survival After TAVI According to Sarcopenia

Sarcopenia Clinical Trial

— TAVI_Sarx  

Official title:

CT Evaluated Sarcopenia Independently Predicts the Overal Survival After Transcatheter Aortic Valve Implantation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05672160
• Other study ID #: TAVI_Sarx
• Status: Completed
• Start date: January 1, 2022
• Est. completion date: January 2, 2023

Study information

• Verified date: January 2023
• Source: Nemocnice AGEL Trinec-Podlesi a.s.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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?

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?

Recruitment information / eligibility

• Status: Completed
• Enrollment: 930
• Est. completion date: January 2, 2023
• Est. primary completion date: January 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• patients udergone TAVI procedure

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Aortic Valve Stenosis
• Sarcopenia

Intervention

Diagnostic Test:
• CT evaluated sarcopenia
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.

Locations

Country	Name	City	State
Czechia	AGELTrinecPodlesi	Trinec	Ceská Republika

Sponsors (1)

Lead Sponsor	Collaborator
Nemocnice AGEL Trinec-Podlesi a.s.

Country where clinical trial is conducted

Czechia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overal survival	Time from the TAVI procedure to death	11 years