Impact of Trans-catheter Aortic Valve Implantation on Renal Function (TAVIKOD)

May 31, 2026 updated by: Romagnoli Enrico, Fondazione Policlinico Universitario Agostino Gemelli IRCCS

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Estimated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Italy
    • RM
      • Roma, RM, Italy, 00168
        • Recruiting
        • Enrico Romagnoli
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Francesco Burzotta, MD, PhD
        • Sub-Investigator:
          • Cristina Aurigemma, MD, PhD
        • Sub-Investigator:
          • Carlo Trani, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

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;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
TAVI patients
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of Contrast-induced acute kidney injuy
Time Frame: In-hospital (up to day 5)
contrast medium induced acute kidney injury according to KDIGO classification
In-hospital (up to day 5)
Rate of 1-year mortality
Time Frame: 1-year follow-up
Incidence of 1-year mortality after TAVI procedure in patients with and without post-procedural CI-AKI.
1-year follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of 30-day procedural safety
Time Frame: 1-month follow-up
Procedure 30-day safety endpoint including: all cause mortality, stroke, infections, sepsis.
1-month follow-up
Days of hospitalization
Time Frame: In hospital (up to day 30)
Days of hospitalization following TAVI procedure
In hospital (up to day 30)
Rate of 5-year major cardiovascular event
Time Frame: 5-year follow-up
Five-year composite rate of all-cause mortality, stroke, myocardial infarction, coronary revascularization, hospitalization
5-year follow-up

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical predictors of contrast-induced acute kidney injury in TAVI
Time Frame: In-hospital (up to day 5)
Patient-related and procedure-related elements associated with the risk of post TAVI acute kidney injury
In-hospital (up to day 5)
Impact of AKI in surgical vs percutaneous treatment of aortic stenosis
Time Frame: 30-day follow up
Comparison between percutaneous and surgical aortic stenosis treatment in patients with contrast medium-induced AKI during preliminary diagnostic exams
30-day follow up
Post TAVI acute kidney injury risk in patients with concurrent coronary artery disease
Time Frame: In-hospital (up to day 5)
Incidence of AKI in patients with concurrent coronary artery disease (CAD)
In-hospital (up to day 5)
Peri-procedural bleeding incidence in patients with post-procedural CI-AKI
Time Frame: 30-day follow up
Assessment of access-related and non access related bleeding incidence in patients with and without post-procedural CI-AKI.
30-day follow up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Investigators

  • Principal Investigator: Enrico Romagnoli, Fondazione Policlinico Universitario Agostino Gemelli

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 30, 2024

Primary Completion (Estimated)

August 30, 2028

Study Completion (Estimated)

August 30, 2033

Study Registration Dates

First Submitted

March 9, 2023

First Submitted That Met QC Criteria

May 31, 2026

First Posted (Actual)

June 4, 2026

Study Record Updates

Last Update Posted (Actual)

June 4, 2026

Last Update Submitted That Met QC Criteria

May 31, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3940

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All IPD that underlie published results will be shared on reasonable request to the principal investigator.

IPD Sharing Time Frame

From May 2025 (primary end-point completion) to May 2029 (study end)

IPD Sharing Access Criteria

request to the principal investigator.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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