RecruitingNCT07626710

Impact of Trans-catheter Aortic Valve Implantation on Renal Function

Impact of Trans-catheter Aortic Valve Implantation on Kidney Response to Contrast Dye Administration: an Observational Registry

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Enrollment

1,000 participants

Start Date

Aug 30, 2024

Study Type

OBSERVATIONAL

Conditions

Chronic Kidney Diseases Aortic Valve Stenosis Renal Failure Acute Chronic

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

Min Age: 18 Years

Inclusion Criteria5

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 Criteria6

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;