TAVI_Sarx: Overal Survival After TAVI According to Sarcopenia

• Sponsor: Nemocnice AGEL Trinec-Podlesi a.s. (Other)
• Overall Status: Completed
• CT.gov ID: NCT05672160
• Collaborator: (none)
• Enrollment: 930
• Location: 1
• Actual Duration (Months): 12
• Patients Per Site Per Month: 77.3

Study Details

Study Description

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?

Condition or Disease	Intervention/Treatment	Phase
Sarcopenia; Aortic Valve Stenosis	Diagnostic Test: CT evaluated sarcopenia

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

• Study Type: Observational
• Actual Enrollment: 930 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: CT Evaluated Sarcopenia Independently Predicts the Overal Survival After Transcatheter Aortic Valve Implantation
• Actual Study Start Date: Jan 1, 2022
• Actual Primary Completion Date: Jan 1, 2023
• Actual Study Completion Date: Jan 2, 2023

Outcome Measures

Primary Outcome Measures

1. Overal survival [11 years]

   Time from the TAVI procedure to death

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• patients udergone TAVI procedure

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	AGELTrinecPodlesi	Třinec	Česká Republika	Czechia	73961

Sponsors and Collaborators

• Nemocnice AGEL Trinec-Podlesi a.s.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Matej Pekar, MD, PhD, Mr. Matej Pekar, MD, PhD, Nemocnice AGEL Trinec-Podlesi a.s.
• ClinicalTrials.gov Identifier: NCT05672160
• Other Study ID Numbers: TAVI_Sarx
• First Posted: Jan 5, 2023
• Last Update Posted: Jan 5, 2023
• Last Verified: Jan 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Matej Pekar, MD, PhD, Mr. Matej Pekar, MD, PhD, Nemocnice AGEL Trinec-Podlesi a.s.: sarcopenia; survival; TAVI
• Additional relevant MeSH terms: Sarcopenia; Aortic Valve Stenosis

Study Results

No Results Posted as of Jan 5, 2023