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Clinical Trials in Italy / NCT07626710
Recruiting Observational

Impact of Trans-catheter Aortic Valve Implantation on Renal Function

NCT07626710 · tracked via the Priya Life Science Italy tracker
Phase
Observational
Started
2024-08-30
Last updated
2026-06-04

Condition(s) studied

Aortic Valve StenosisChronic Kidney DiseasesRenal Failure Acute Chronic

Investigational drug(s) / intervention(s)

Trans-catheter aortic valve implantation (TAVI)

Trans-catheter aortic valve implantation (TAVI): Transcatheter aortic valve implantation (TAVI) for severe aortic stenosis

Study summary

Both contrast-induced acute kidney injury (AKI) and pre-existing chronic kidney disease are associated with an increased mortality risk in patients requiring aortic valve replacement. Nonetheless, the direct haemodynamic impact of the aortic barrage (i.e. pre-renal mechanism) on renal function compromising and its reversibility in patients undergoing trans-catheter aortic valve implantation (TAVI) is unknown.

This registry aims to evaluate the effect of severe aortic stenosis removal on the risk of contrast-induced acute renal injury (CI-AKI) during TAVI procedures and on renal function evolution

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Age \>18 years with a life expectancy \>1 year; * Patient candidate for percutaneous aortic valve implantation after formal indication of our "Heart Team". * Patient performed at least one contrast-based exam other than the TAVI procedure in the previous two months. * Patients had adequate renal function assessment after each contrast medium administration (TAVI procedure included) with at least three post-procedural measurements in the following 5 days. * Patients were informed of the possibility to be the object of anonymized data collection for study protocols approved by the internal Ethical Committee and had provided written informed consent to the procedure (for patients before 2018) or had provided written informed consent to the research purposes of IRCCS (for patients from 2018 to date). Exclusion Criteria: * Female with childbearing potential or lactating; * Acute or chronic end-stage renal dysfunction defined as estimated glomerular filtration rate (eGFR) \<30 mL/min/1.73m2); * Candidate for dialysis treatment; * Co-morbidities that could interfere with the completion of study procedures, or life expectancy of less than 1 year; * Absent or incomplete renal function assessment after each contrast-based procedure; * Participating in another investigational drug or device trial that has not completed the primary endpoint or would interfere with the endpoints of this study;

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Enrico Romagnoli Roma RM Recruiting

More Fondazione Policlinico Universitario Agostino Gemelli IRCCS trials in Italy

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07626710 on ClinicalTrials.gov ↗ ← All trials in Italy