Aortic Valve Stenosis Clinical Trials

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

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Observational
SUMMARY

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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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).

Locations
Other Locations
Italy
Enrico Romagnoli
RECRUITING
Roma
Contact Information
Primary
Enrico Romagnoli, MD, PhD
enromagnoli@gmail.com
+390630154187
Backup
Benedetta Brancadoro
benedetta.brancadoro@unicatt.it
+390630154187
Time Frame
Start Date: 2024-08-30
Estimated Completion Date: 2033-08-30
Participants
Target number of participants: 1000
Treatments
TAVI patients
All patients undergoing trans-catheter aortic valve implantation (TAVI) for severe aortic stenosis at Our Institution during the study period.
Sponsors
Leads: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

This content was sourced from clinicaltrials.gov