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NCT07052071: GUT-TAVI
Impact of Transcatheter Aortic Valve Implantation (TAVI) on the Gut Microbiota in Patients With Aortic Valve Stenosis
trial testing TAVI in Aortic Stenosis in 40 participants. Currently enrolling.
1 September 2027
Quick facts
| Lead sponsor | Hippocration General Hospital |
|---|---|
| Status | Recruiting now |
| Study type | OBSERVATIONAL |
| Enrollment | 40 |
| Start date | 1 September 2025 |
| Primary completion | 1 September 2027 |
| Estimated completion | 1 November 2027 |
| Sites | 1 location across Greece |
Drugs / interventions tested
- TAVI
Conditions studied
- Aortic Stenosis — all drugs for Aortic Stenosis →
- Gut Microbiome — all drugs for Gut Microbiome →
- Gut Microbiota — all drugs for Gut Microbiota →
- TAVI — all drugs for TAVI →
Sponsor
Hippocration General Hospital
Who can join
Eligibility, any sex, with Aortic Stenosis or Gut Microbiome. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Transcatheter aortic valve implantation and gut microbiota: Rationale and design of the 'GUT-TAVI' cohort study.
Manti M, Dimitriadis K, Dri E, Mavromoustakou K, et al · · 2026 · PMID 41910441 · DOI 10.1177/00368504261426427
Verify or expand the search:
- PubMed search for NCT07052071
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of TAVI
Trials testing the same drug.
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- NCT04817735 — The CASPER Registry · NA · completed
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- NCT04600739 — Validation of a Novel, Non-Dimensional Approach for Estimation of Pressure Gradients in Aortic Stenosis · unknown
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Currently open trials in the same condition.
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Other Hippocration General Hospital trials
Trials by the same sponsor.
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- NCT06208501 — The Predictive Role of Proteomics in Blood Pressure Response of Hypertensive Patients Undergoing Renal Denervation. · unknown
- NCT05549752 — Flecainide Versus Amiodarone in the Cardioversion of Paroxysmal Atrial Fibrillation at the Emergency Department, in Pati · Phase 3 · recruiting
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- NCT04055285 — Effect of Renal Denervation on Atrial Fibrillation · NA · unknown
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07052071 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Hippocration General Hospital
- Last refreshed: 18 November 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07052071.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing