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TAVI study aims to uncover kidney risks from contrast dye

NCT ID NCT07626710

Knowledge-focused Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study observes 1000 people with severe aortic stenosis and kidney disease who are getting a TAVI procedure. Researchers want to see how removing the blocked valve affects the kidneys' response to contrast dye used during the procedure. The goal is to understand if TAVI lowers the risk of kidney injury from the dye.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this could help doctors better predict and prevent kidney damage after TAVI procedures.
What could go wrong
This is an observational study, not a treatment trial. It will not directly test a new therapy, and results may not change current practice.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 1,000 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2024

Expected to finish

Aug 2033

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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) \<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;

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Conditions

The condition(s) this trial relates to.

aortic valve stenosis chronic kidney disease chronic renal failure syndrome kidney failure

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Aortic valve stenosis Chronic kidney diseases Renal failure acute chronic

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Enrico Romagnoli

    RECRUITING

    Roma, RM, 00168, Italy

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