Impact of TAVR on kidney function in people with aortic valve disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This ambispective registry follows adults undergoing trans-catheter aortic valve implantation for severe aortic stenosis to see how the procedure influences renal function and the risk of contrast-induced kidney injury. It compares the incidence of acute kidney injury before and after TAVI and looks at one-year mortality in patients with and without post-procedural kidney injury. Data are collected from a standardized peri-procedural approach and require multiple renal function measurements within five days after each contrast-based assessment. The study leverages historical (retrospective) and ongoing (prospective) data from a single Italian center to characterize renal outcomes associated with TAVI.

Why it matters

Who can join: the full rules

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;

Where it's running

• Enrico Romagnoli
  Roma, Rm, Italy Recruiting

Study contacts

• Principal investigator: Enrico Romagnoli — Fondazione Policlinico Universitario Agostino Gemelli
• Study coordinator: Enrico Romagnoli, MD, PhD
• Email: enromagnoli@gmail.com
• Phone: +390630154187

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Transcatheter Aortic Valve Replacement Registry for Outcomes and Quality Monitoring

  This registry collects information from hospitals about patients undergoing TAVR to see how care and outcomes compare to guidelines and nationwide data.

  Recruiting American College of Cardiology · Washington D.C., District of Columbia · NCT07908355

• Clinical decision support to help consider SGLT2 inhibitors after AKI in type 2 diabetes

  This pilot test checks if a CDS message given to clinicians can help decide whether to consider SGLT2 inhibitors for adults with type 2 diabetes who recently had acute kidney injury.

  Recruiting University of Minnesota · Minneapolis, Minnesota · NCT07868666

• Vericiguat to slow calcific aortic valve narrowing

  This trial tests whether vericiguat can slow the progression of mild-to-moderate calcific aortic valve stenosis compared with placebo.

  Recruiting Phase 2 West China Hospital · Chengdu, Sichuan · NCT07715279

• CHATEAU Registry: Real-world outcomes after TAVR

  This registry collects real-world data from adults who had TAVR between 2021 and 2025 to see how they do over time and how valve performance holds up.

  Recruiting Eunpyeong St. Mary's Hospital · Seoul · NCT07709858

• Hydra THV Transfemoral Valve Implantation in Severe Aortic Stenosis

  This registry tests how safely and effectively the Hydra THV works when implanted through the femoral artery in adults with severe symptomatic aortic stenosis.

  Recruiting at 8 sites Fundación EPIC · Aravaca and 7 other locations · NCT07566624

• How the type of sedation affects recovery after TAVR

  This study will test whether three common sedation approaches (propofol, dexmedetomidine, or midazolam with fentanyl) change how people recover on the first day after transfemoral TAVR.

  Recruiting Phase 4 Endeavor Health · Glenview, Illinois · NCT07556523

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.