An interventional study of TAVI without contrast in Stenosis; Valve, Renal Failure and Renal Insufficiency, sponsored by University of Sao Paulo General Hospital. Status unknown at 1 site in Brazil. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-03-16.
Sponsored by University of Sao Paulo General Hospital · Not applicable, Interventional, and Prevention
Acute renal failure (ARF) after transcatheter aortic valve implantation (TAVI) is a frequent complication, with significant clinical consequences. History of chronic kidney disease and the use of a large amount of iodinated contrast for planning and procedure are among the main risk factors for the development of this complication. The present study aims to: (1) define the role of non-contrast imaging modalities in pre-procedure planning; (2) evaluate the feasibility and safety of a new TAVI technique without using iodinated contrast; (3) to determine the incidence of acute renal failure in patients with aortic stenosis and chronic kidney disease undergoing TAVI, using the new technique without contrast. The study will be divided into two stages. In the pilot phase, 25 consecutive patients with chronic kidney disease (stage ≥ 3a) will have the TAVI planning and procedure performed without the use of iodinated contrast, but with all the steps subjected to verification by the standard technique, to ensure the safety of the patient. The occurrence of the combined primary safety outcome composed of adverse clinical events within 30 days (defined by the VARC-2 criteria) in less than 20% of cases will be used to define the continuity of the study. In the second phase, 50 patients with chronic kidney disease stage ≥ 3b will be submitted to TAVI with the "zero contrast" technique. The primary outcome assessed at this stage of the study will be the incidence of AKI within 7 days after TAVI using the new technique in this high-risk population.
This will be a prospective, single-center, single-arm clinical trial, to be carried out at the Heart Institute of Hospital das Clínicas, Faculty of Medicine, University of São Paulo (InCor - HC - FMUSP). The study will be divided into two phases. The first phase ("pilot") will test the concept, feasibility and safety of using a "zero contrast" strategy to carry out the planning and procedure of TAVI through transfemoral access with the self-expanding bioprosthesis Evolut R / Pro in 25 consecutive patients with CKD. The second phase ("zero contrast") will include 50 patients with CKD who will be submitted to transfemoral TAVI with the Evolut R / Pro bioprosthesis using the "zero contrast" approach, seeking to evaluate the results of the procedure and the incidence of AKI with the new strategy.
3,840 studies on the registry are indexed under Kidney Diseases; 500 are open to participants now.
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Exclusion Criteria:
Diagnostic Test: TAVI without contrast
TAVI without contrast
Pilot Phase: Early safety at 30 days - (VARC-2 criteria)
In the pilot phase, we aim to assess the combined primary safety outcome (at 30 days) including all-cause mortality, severe stroke, bleeding with a risk of death, acute renal failure (stages 2 or 3), peri-procedure infarction, major vascular complication and valve-related dysfunction requiring repeated intervention (aortic valvuloplasty, TAVI or surgical valve replacement).
Time frame: 30 days
Zero Contrast Phase: incidence of AKI up to a7 days
The incidence of AKI up to 7 days after TAVI will be the primary outcome of the "zero contrast" phase. Acute renal failure will be defined according to the VARC-2 criteria and classified into 3 stages: * Stage 1: 1.5-1.99-fold increase in serum creatinine compared to baseline OR absolute increase of 0.3 mg / dL OR urine output less than 0.5 mL / kg / h for more than 6 hours, but for less than 12 h; * Stage 2: 2.0-2.99-fold increase in serum creatinine compared to baseline OR urine output below 0.5 mL / kg / h for more than 12 hours, but for less than 24 hours; * Stage 3: greater than 3-fold increase in serum creatinine compared to baseline OR baseline serum creatinine equal to or greater than 4.0 mg / dL with an acute increase of at least 0.5 mg / dL OR urine output less than 0, 3 mL / kg / h for 24h or more OR anuria for 12h or more. The need for renal replacement therapy, regardless of other criteria, is classified as stage 3 AKI.
Time frame: 7 days
Pilot phase: Accuracy in choosing the size of the bioprosthesis.
Accuracy in choosing the size of the bioprosthesis based on the non-contrast imaging modalities, compared to the size chosen by another experienced member of the heart-team through the assessment of the contrast-enhanced TCMS, the gold standard method for this purpose. Accuracy is defined as the number of cases with correct choice of the size of the transcatheter prosthesis, divided by the total number of cases treated in the pilot phase.
Time frame: Procedure - 1 day
Pilot phase: Device success (VARC-2 criteria)
Success of the device using the "zero contrast" strategy for the TAVI procedure. The device's Absence of death in the procedure AND correct positioning of a single bioprosthesis with the intended performance (mean gradient \<20 mmHg and absence of moderate or important aortic insufficiency).
Time frame: Procedure - 1 day
Zero Contrast phase: Device success (VARC-2 criteria)
Absence of death in the procedure AND correct positioning of a single bioprosthesis with the intended performance (mean gradient \<20 mmHg and absence of moderate or significant aortic insufficiency). 2. Safety at 30 days: outcome consisting of death from all causes, stroke, bleeding with risk of death, major vascular complication, coronary obstruction, ARF stages 2 or 3, valve-related dysfunction requiring repeated intervention (aortic valvuloplasty) , TAVI or surgical valve replacement)
Time frame: Procedure - 1 day
Zero Contrast phase: Early safety at 30 days - (VARC-2 criteria)
Outcome consisting of death from all causes, stroke, bleeding with risk of death, major vascular complication, coronary obstruction, ARF stages 2 or 3, valve-related dysfunction requiring repeated intervention (aortic valvuloplasty) , TAVI or surgical valve replacement)
Time frame: 30 days
Plan to share: Undecided
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University of Sao Paulo General Hospital