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How Aortic Valve Replacement Affects Kidney Function and Reaction to Contrast Dye

Observes kidney function in adults having transcatheter aortic valve implantation for aortic stenosis.

Key facts

Who runs it
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Where
Roma, ItalySee the site
Trial code
Registry title
Impact of Trans-catheter Aortic Valve Implantation on Renal Function
Status
Recruiting
People taking part
1,000 people, planned
Started
30 Aug 2024
Expected to end
30 Aug 2033
Type of study
Observational
Treatments tested
  • Trans-catheter aortic valve implantation (TAVI)
Record updated
4 June 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with severe aortic stenosis who are going to have a valve implanted through a catheter (TAVI). It studies how the kidneys react to contrast dye.

Age
Over 18 years
Sex
All sexes
Disease stage
Severe aortic stenosis, with a Heart Team decision for TAVI. Life expectancy over 1 year.
Earlier treatment
At least one other contrast-dye exam in the previous two months.

Main reasons for not taking part

  • Women who could become pregnant or are breastfeeding
  • Kidney function below 30 mL/min/1.73m2 (eGFR)
  • Candidate for dialysis treatment
  • Illnesses that could get in the way of the study, or life expectancy under 1 year
  • Missing or incomplete kidney tests after a contrast-dye procedure

The registry criteria, word for word

Show all 11 criteriaShow less

Who can take part

  • 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)

Who cannot take part

  • Participating in another investigational drug or device trial that has not completed the primary endpoint or would interfere with the endpoints of this study
  • Acute or chronic end-stage renal dysfunction defined as estimated glomerular filtration rate (eGFR) <30 mL/min/1.73m2)
  • 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

Where in Italy

  • Enrico RomagnoliRoma, ItalyContact: Enrico Romagnoli, MD, PhDTaking people

About the trial

What the trial wants to find out

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.

Read full original descriptionShow less

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

The group in the trial

  • TAVI patients

    All patients undergoing trans-catheter aortic valve implantation (TAVI) for severe aortic stenosis at Our Institution during the study period.

    Treatment: Trans-catheter aortic valve implantation (TAVI)

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Impact of Trans-catheter Aortic Valve Implantation on Kidney Response to Contrast Dye Administration: an Observational Registry
Plain-language title
How Aortic Valve Replacement Affects Kidney Function and Reaction to Contrast DyeGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 13 November 2026.
Record updated
4 June 2026