Impact of Trans-catheter Aortic Valve Implantation on Renal Function
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorFondazione Policlinico Universitario Agostino Gemelli IRCCS
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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;
Trial population
All patients undergoing trans-catheter aortic valve implantation (TAVI) for severe aortic stenosis at Our Institution will be eligible for the study.
Trial design
Design model
Cohort
Time perspective
Other
Treatments tested in this trial
Trans-catheter aortic valve implantation (TAVI)
Procedure/SurgeryTranscatheter aortic valve implantation (TAVI) for severe aortic stenosis
Treatment groups
1,000 Participants
are divided into 1 treatment groupGroup A: TAVI patients1 intervention
Trial outcomes
Primary outcomes
1
Rate of Contrast-induced acute kidney injuy
contrast medium induced acute kidney injury according to KDIGO classification
Time frame
In-hospital (up to day 5)2
Rate of 1-year mortality
Incidence of 1-year mortality after TAVI procedure in patients with and without post-procedural CI-AKI.
Time frame
1-year follow-upSecondary outcomes
1
Rate of 30-day procedural safety
Procedure 30-day safety endpoint including: all cause mortality, stroke, infections, sepsis.
Time frame
1-month follow-up2
Days of hospitalization
Days of hospitalization following TAVI procedure
Time frame
In hospital (up to day 30)3
Rate of 5-year major cardiovascular event
Five-year composite rate of all-cause mortality, stroke, myocardial infarction, coronary revascularization, hospitalization
Time frame
5-year follow-upOther outcomes
1
Clinical predictors of contrast-induced acute kidney injury in TAVI
Patient-related and procedure-related elements associated with the risk of post TAVI acute kidney injury
Time frame
In-hospital (up to day 5)2
Impact of AKI in surgical vs percutaneous treatment of aortic stenosis
Comparison between percutaneous and surgical aortic stenosis treatment in patients with contrast medium-induced AKI during preliminary diagnostic exams
Time frame
30-day follow up3
Post TAVI acute kidney injury risk in patients with concurrent coronary artery disease
Incidence of AKI in patients with concurrent coronary artery disease (CAD)
Time frame
In-hospital (up to day 5)4
Peri-procedural bleeding incidence in patients with post-procedural CI-AKI
Assessment of access-related and non access related bleeding incidence in patients with and without post-procedural CI-AKI.
Time frame
30-day follow upSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov