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NCT07626710
Impact of Trans-catheter Aortic Valve Implantation on Renal Function
Conditions: Aortic Valve Stenosis, Chronic Kidney Diseases, Renal Failure Acute Chronic
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 1000
Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Location: Enrico Romagnoli Roma RM
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 Criteria
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) \
Source: ClinicalTrials.gov (NCT07626710). StuddyBuddy aggregates publicly available trial information.