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

NCT04581694 | Unknown

• 1 other identifier: FábioSândoli
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (2)

• 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).

  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.

  7 days

Secondary Outcomes (4)

• Pilot phase: Accuracy in choosing the size of the bioprosthesis.

  Procedure - 1 day

• Pilot phase: Device success (VARC-2 criteria)

  Procedure - 1 day

• Zero Contrast phase: Device success (VARC-2 criteria)

  Procedure - 1 day

• Zero Contrast phase: Early safety at 30 days - (VARC-2 criteria)

  30 days

Study Arms (1)

TAVI without contrast

EXPERIMENTAL

Diagnostic Test: TAVI without contrast

Interventions

TAVI without contrast DIAGNOSTIC_TEST

TAVI without contrast

TAVI without contrast

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Symptomatic patients with severe aortic valve stenosis (AoS).
• CKD in stage ≥3a (GFR \<60mL / min / 1.73m2).
• Signature of the free and informed consent form (ICF).

You may not qualify if:

• \- Any condition considered a contraindication for the implantation of a biological valve prosthesis (for example, the patient has an indication for mechanical valve prosthesis).
• Hypersensitivity or known contraindication to any of the following items that cannot be adequately premedicated: aspirin, clopidogrel or heparin (HIT / HITTS) nitinol (titanium or nickel) the contrast medium (pilot phase)
• Blood dyscrasias: leukopenia (white blood cell count \<1000 / mm3), thrombocytopenia (platelet count \<50,000 cells / mm3), history of hemorrhagic diathesis, coagulopathy or hypercoagulable states.
• Active infection, including active endocarditis.
• Cardiogenic shock manifested by low cardiac output, dependence on vasopressors or mechanical hemodynamic support.
• Recent stroke (up to 2 months after heart-team evaluation) or transient ischemic attack.
• Gastrointestinal bleeding that prevents platelet anticoagulation or anti-aggregation.
• Refusal to transfuse blood.
• Severe dementia (resulting in the inability to provide informed consent for the study / procedure).
• Life expectancy estimated at less than 12 months.
• Other medical, social or psychological conditions that, in the investigator's opinion, prevent the patient from consenting or adhering adequately to the protocol.
• Pre-existing prosthetic heart valve in the aortic position.
• Presence of stenosis or significant mitral regurgitation.
• Presence of obstructive hypertrophic cardiomyopathy.
• Clinical indication for coronary angiography or percutaneous coronary intervention in the period including the previous 30 days and 30 days after the TAVI procedure. In this case, the use of contrast media for these procedures can be a confusing factor for the analysis of the primary study outcome.

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead

Study Sites (1)

Heart Institute - InCor. University of Sao Paulo Medical School

São Paulo, 05403-900, Brazil

RECRUITING

MeSH Terms

Conditions

Constriction, Pathologic; Renal Insufficiency

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Fábio S Brito Jr., PhD

  Structural Heart Disease - Interventional cardiologist

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fabio S Brito, PHDq

CONTACT

+551126615286; fabio.cardiol@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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).

Study Record Dates

• First Submitted: September 25, 2020
• First Posted: October 9, 2020
• Study Start: December 1, 2020
• Primary Completion: April 1, 2022
• Study Completion: April 1, 2022
• Last Updated: March 16, 2021

Record last verified: 2021-03

Locations

BR (1)