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Transcatheter Implantation of Aortic Bioprosthesis Without the Use of Iodinated Contrast in Patients With Chronic Kidney Disease

NCT04581694 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2021-03-16

No results posted yet for this study

Summary

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.

Conditions

  • Stenosis; Valve
  • Renal Failure
  • Renal Insufficiency

Interventions

DIAGNOSTIC_TEST

TAVI without contrast

TAVI without contrast

Sponsors & Collaborators

  • University of Sao Paulo General Hospital

    lead OTHER

Principal Investigators

  • Fábio S Brito Jr., PhD · Structural Heart Disease - Interventional cardiologist

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-01
Primary Completion
2022-04-01
Completion
2022-04-01

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04581694 on ClinicalTrials.gov