Impact of Trans-catheter Aortic Valve Implantation on Renal Function (NCT07626710) | Clinical Trial Compass
RecruitingNot Applicable
Impact of Trans-catheter Aortic Valve Implantation on Renal Function
Italy1,000 participantsStarted 2024-08-30
Plain-language 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
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This study is specifically tracking whether the TAVI procedure causes contrast-induced kidney injury — given that I already have chronic kidney disease, how concerned are you about that risk in my particular case, and how would my kidneys be monitored during and after the procedure?
2The trial is measuring one-year mortality as a primary outcome, which suggests there's meaningful uncertainty about survival — can you help me understand what that means for someone with my combination of aortic stenosis and kidney disease, and how my individual risk compares?
3Since this trial has no assigned phase, it appears to be an observational study rather than a test of a new treatment — does that mean TAVI itself is already standard care for my condition, and if so, would I receive the same treatment whether or not I enroll?
4This study is actively recruiting right now — if I were to discuss joining, what would actually be expected of me in terms of extra visits, blood tests, or kidney function monitoring over that one-year follow-up period?
5Are there patients with my level of kidney function for whom you'd recommend a different treatment path — like medical management or surgical valve replacement — before considering TAVI, and how would participation in this trial affect that decision?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.