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RECRUITING
NCT07052071

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

Sponsor: Hippocration General Hospital

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

Any - Any

Study Type

OBSERVATIONAL

Enrollment

40

Start Date

2025-09-01

Completion Date

2027-11-01

Last Updated

2025-11-18

Healthy Volunteers

No

Interventions

PROCEDURE

TAVI

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.

Locations (1)

Hippokration General Hospital of Athens

Athens, Greece