RecruitingNCT07052071

Impact of Transcatheter Aortic Valve Implantation (TAVI) on the Gut Microbiota in Patients With Aortic Valve Stenosis

Sponsor

Hippocration General Hospital

Enrollment

40 participants

Start Date

Sep 1, 2025

Study Type

OBSERVATIONAL

Conditions

Gut Microbiome TAVI Gut Microbiota Aortic Stenosis TAVI(Transcatheter Aortic Valve Implantation)

Summary

This study investigates the impact of transcatheter aortic valve implantation (TAVI) on the composition and function of the gut microbiota in patients with severe aortic valve stenosis. The improvement in haemodynamics following TAVI may positively influence gut microbial balance by increasing splanchnic perfusion and reducing intestinal congestion. A total of 40 patients undergoing TAVI at the "Hippokration" General Hospital of Athens will be enrolled, with the aim of analysing stool and blood samples before and after the procedure. The primary endpoint is the change in gut microbiota composition two months post-TAVI, assessed via 16S rRNA sequencing. Secondary endpoints include changes in serum TMAO levels and their association with the severity of aortic stenosis and post-procedural valve haemodynamics. Data will be collected at two timepoints (1 month up to 1 day pre-TAVI and 3 to 4 months post-TAVI), along with dietary questionnaires to account for potential confounding factors. This observational study aims to highlight the potential relationship between cardiac function and the gut microbiome, offering new perspectives for targeted therapeutic strategies in cardiovascular disease.

Eligibility

Inclusion Criteria1

Aortic stenosis suitable for TAVI

Exclusion Criteria9

Patients will be excluded if they present any condition or intervention that may independently affect gut microbiota composition. These include:
Use of antibiotics, systemic corticosteroids, antivirals, probiotics, bile acid sequestrants, or new medications within one month prior to enrollment.
History of inflammatory bowel disease.
End-stage renal disease requiring dialysis.
End-stage chronic liver disease.
Acute infection. Patients with aortic stenosis due to rheumatic fever or infectious endocarditis will be excluded.
Active cancer under treatment.
Psychiatric illness impairing ability to consent.
Substance or alcohol abuse.

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Interventions

PROCEDURETAVI

Transcatheter Aortic Valve Implantation (TAVI) is a minimally invasive method for replacing the aortic valve in patients with severe aortic stenosis. The procedure involves the placement of a bioprosthetic valve within the patient's degenerated aortic valve via a catheter.