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Impact of Transcatheter Aortic Valve Implantation (TAVI) on the Gut Microbiota in Patients With Aortic Valve Stenosis
Sponsor: Hippocration General Hospital
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
Conditions
Interventions
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