NCT07626710Recruiting
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
Source: ClinicalTrials.gov · Last updated 4 Jun 2026
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 1000 (estimated)
- First submitted
- 9 Mar 2023
- Start date
- 30 Aug 2024
- Primary completion date
- 30 Aug 2028
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Diseases
- Chronic kidney disease
- NCT number
- NCT07626710
What you commit to
- Study type: Observational
- Planned participants: 1000
- From 30 Aug 2024 to the primary completion date, 30 Aug 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Participating in another investigational drug or device trial that has not completed the primary endpoint or would interfere with the endpoints of this study;
Lab values
- Acute or chronic end-stage renal dysfunction defined as estimated glomerular filtration rate (eGFR) \<30 mL/min/1.73m2);
Other
- Female with childbearing potential or lactating;
- 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;
Who the study is looking for
- 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).
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Enrico Romagnoli Coordinator of this site? Confirm its status | Roma | Italy | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.