Actively Recruiting
Impact of Transcatheter Aortic Valve Implantation (TAVI) on the Gut Microbiota in Patients With Aortic Valve Stenosis
Led by Hippocration General Hospital · Updated on 2025-11-18
40
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to explore how transcatheter aortic valve implantation (TAVI) affects the gut microbiota in patients with severe aortic valve stenosis. The study investigates whether improved heart function after TAVI can positively change gut bacteria by enhancing blood flow to the intestines and reducing congestion. The trial will enroll 40 patients undergoing TAVI to analyze stool and blood samples before and after the procedure. Participants will undergo two main study phases: before TAVI and three to four months after TAVI. During these phases, stool samples will be collected for 16S rRNA sequencing to assess gut microbiota changes, and blood samples will measure markers like TMAO and other related health indicators. Dietary questionnaires will also be completed at each timepoint to consider diet’s influence on gut bacteria. Participants will be assessed at baseline (1 month to 1 day before TAVI) and followed up 3 to 4 months after the procedure. Data collected include medical history, echocardiography, blood tests, stool samples, and dietary information. The study’s main outcome is the change in gut microbiota composition after TAVI, with secondary outcomes examining serum TMAO levels and their relationship to heart valve severity and function. Safety and eligibility are monitored throughout, with follow-up adjusted if antibiotics are used.
CONDITIONS
Brief Title
Impact of Transcatheter Aortic Valve Implantation (TAVI) on the Gut Microbiota in Patients With Aortic Valve Stenosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of aortic stenosis suitable for TAVI
You will not qualify if you...
- 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 including aortic stenosis due to rheumatic fever or infectious endocarditis
- Active cancer under treatment
- Psychiatric illness impairing ability to consent
- Substance or alcohol abuse
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 1 day before TAVI
Participants undergo baseline assessments including collection of blood and stool samples, dietary questionnaires, and echocardiography up to 24 hours before the TAVI procedure.
1 visit (in-person)
Duration - 1 day
Participants undergo the Transcatheter Aortic Valve Implantation (TAVI) procedure, a minimally invasive method to replace the aortic valve.
1 visit (in-person)
Duration - 3 to 4 months after TAVI
Participants have follow-up assessments 3 to 4 months after TAVI to evaluate changes in gut microbiota and blood markers. If antibiotics were taken, the follow-up is delayed by 1 month.
1 follow-up visit (in-person)
Trial Site Locations
Total: 1 location
1
Hippokration General Hospital of Athens
Athens, Greece
Actively Recruiting
Research Team
K
Konstantinos Tsioufis
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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