Transcatheter Implantation of Aortic Bioprosthesis Without the Use of Iodinated Contrast in Patients With Chronic Kidney Disease
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Renal Failure
- Renal Insufficiency
- Stenosis; Valve
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentIntervention Model Description: Twenty-five patients who meet all inclusion criteria and without exclusion criteria will be submitted to TAVI using the "zero contrast" strategy. Four imaging methods will be used to evaluate this new strategy: (1) multi-slice computed tomography (TCMS) without contrast, (2) aortoiliac angiography with CO2, (3) nuclear magnetic resonance (MR) of heart without contrast and (4 ) 3D transesophageal echocardiogram (3D TEE).Masking: None (Open Label)Primary Purpose: Prevention
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
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, feas...
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.
Tracking Information
- NCT #
- NCT04581694
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Fábio S Brito Jr., PhD Structural Heart Disease - Interventional cardiologist
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