Overal Survival After TAVI According to Sarcopenia

NCT ID: NCT05672160

Last Updated: 2023-01-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

930 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-01-01

Study Completion Date

2023-01-02

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Sarcopenia Aortic Valve Stenosis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* patients udergone TAVI procedure

Exclusion Criteria

* patients with incomplete TAVI procedure, patients without clinical follow up
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Nemocnice AGEL Trinec-Podlesi a.s.

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Matej Pekar, MD, PhD

Mr. Matej Pekar, MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

AGELTrinecPodlesi

Třinec, Česká Republika, Czechia

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Czechia

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

TAVI_Sarx

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

RESTORE-TAVI Pilot
NCT06121921 COMPLETED NA