An observational study in Aortic Valve Stenosis, Chronic Kidney Diseases and Renal Failure Acute Chronic, sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS. Recruiting at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-04.
Sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Observational
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
All patients undergoing trans-catheter aortic valve implantation (TAVI) for severe aortic stenosis at Our Institution after the introduction of a standardized approach (2017 - TAVI lite technique) will be eligible for the study. To be enrolled in this registry, patients need to have performed both diagnostic preliminary exams (coronary angiography, percutaneous coronary intervention, or CT) and TAVI procedure in our hospital within maximal time lapse of two months. A complete renal function assessment after each contrast-based procedure (i.e. at least three measurements) is also an essential pre-requisite for enrolment.
Study design: ambispective registry. Estimated population size: 340 for the retrospective phase (based on annual TAVI procedure rate of \~150); 760 for the prospective phase (based on annual TAVI procedure rate of \~200) The incidence of contrast medium-induced acute kidney injury according to Kidney Disease Improving Global Outcomes (KDIGO) classification before and after the TAVI procedure will be the primary end-point of the study. The Incidence of 1-year mortality after TAVI procedure in patients with and without post-procedural CI-AKI will be the co-primary end-point.
985 studies on the registry are indexed under Aortic Valve Stenosis; 283 are open to participants now.
This study's planned enrollment of 1,000 is above the median of 200 across 424 observational studies indexed under Aortic Valve Stenosis.
Browse Aortic Valve Stenosis studies →Fondazione Policlinico Universitario Agostino Gemelli IRCCS is the lead sponsor of 920 studies on the registry; 529 are open to participants now.
Counted across the registry records on this site, refreshed daily.
All patients undergoing trans-catheter aortic valve implantation (TAVI) for severe aortic stenosis at Our Institution will be eligible for the study.
Exclusion Criteria:
All patients undergoing trans-catheter aortic valve implantation (TAVI) for severe aortic stenosis at Our Institution during the study period.
Procedure: Trans-catheter aortic valve implantation (TAVI)
Transcatheter aortic valve implantation (TAVI) for severe aortic stenosis
Rate of Contrast-induced acute kidney injuy
contrast medium induced acute kidney injury according to KDIGO classification
Time frame: In-hospital (up to day 5)
Rate of 1-year mortality
Incidence of 1-year mortality after TAVI procedure in patients with and without post-procedural CI-AKI.
Time frame: 1-year follow-up
Rate of 30-day procedural safety
Procedure 30-day safety endpoint including: all cause mortality, stroke, infections, sepsis.
Time frame: 1-month follow-up
Days of hospitalization
Days of hospitalization following TAVI procedure
Time frame: In hospital (up to day 30)
Rate of 5-year major cardiovascular event
Five-year composite rate of all-cause mortality, stroke, myocardial infarction, coronary revascularization, hospitalization
Time frame: 5-year follow-up
Clinical predictors of contrast-induced acute kidney injury in TAVI
Patient-related and procedure-related elements associated with the risk of post TAVI acute kidney injury
Time frame: In-hospital (up to day 5)
Impact of AKI in surgical vs percutaneous treatment of aortic stenosis
Comparison between percutaneous and surgical aortic stenosis treatment in patients with contrast medium-induced AKI during preliminary diagnostic exams
Time frame: 30-day follow up
Post TAVI acute kidney injury risk in patients with concurrent coronary artery disease
Incidence of AKI in patients with concurrent coronary artery disease (CAD)
Time frame: In-hospital (up to day 5)
Peri-procedural bleeding incidence in patients with post-procedural CI-AKI
Assessment of access-related and non access related bleeding incidence in patients with and without post-procedural CI-AKI.
Time frame: 30-day follow up
Plan to share: Yes — All IPD that underlie published results will be shared on reasonable request to the principal investigator.
Supporting information: Study protocol, Csr
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Fondazione Policlinico Universitario Agostino Gemelli IRCCS