Back to resultsTranscatheter Implantation of Aortic Bioprosthesis Without the Use of Iodinated Contrast in Patients With Chronic Kidney Disease
Primary Purpose
Stenosis; Valve, Renal Failure, Renal Insufficiency
Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
TAVI without contrast
Sponsored by
About this trial
This is an interventional prevention trial for Stenosis; Valve
Eligibility Criteria
Inclusion Criteria:
- 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).
Exclusion Criteria:
- 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.
- Contraindication for the transfemoral approach based on evaluation by non-contrast TCMS and by CO2 aortoiliac angiography (anatomical screening).
- High risk of rupture of the ring or significant residual paravalvular leak due to important calcification of the left ventricular outflow tract.
- High risk of coronary occlusion (height of the coronary ostium <10 mm with narrow SOV: <1 mm greater than the size of the bioprosthesis) defined by imaging methods.
Sites / Locations
- Heart Institute - InCor. University of Sao Paulo Medical SchoolRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
TAVI without contrast
Arm Description
Outcomes
Primary Outcome Measures
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).
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.
Secondary Outcome Measures
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.
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).
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)
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)
Full Information
NCT ID
NCT04581694
First Posted
September 25, 2020
Last Updated
March 12, 2021
Sponsor
University of Sao Paulo General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04581694
Brief Title
Transcatheter Implantation of Aortic Bioprosthesis Without the Use of Iodinated Contrast in Patients With Chronic Kidney Disease
Official Title
Transcatheter Implantation of Aortic Bioprosthesis Without the Use of Iodinated Contrast in Patients With Chronic Kidney Disease
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Unknown status
Study Start Date
December 1, 2020 (Actual)
Primary Completion Date
April 1, 2022 (Anticipated)
Study Completion Date
April 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo General Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
Detailed 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, 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stenosis; Valve, Renal Failure, Renal Insufficiency
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
75 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
TAVI without contrast
Arm Type
Experimental
Intervention Type
Diagnostic Test
Intervention Name(s)
TAVI without contrast
Intervention Description
TAVI without contrast
Primary Outcome Measure Information:
Title
Pilot Phase: Early safety at 30 days - (VARC-2 criteria)
Description
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
Title
Zero Contrast Phase: incidence of AKI up to a7 days
Description
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
Secondary Outcome Measure Information:
Title
Pilot phase: Accuracy in choosing the size of the bioprosthesis.
Description
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
Title
Pilot phase: Device success (VARC-2 criteria)
Description
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
Title
Zero Contrast phase: Device success (VARC-2 criteria)
Description
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
Title
Zero Contrast phase: Early safety at 30 days - (VARC-2 criteria)
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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).
Exclusion Criteria:
- 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.
Contraindication for the transfemoral approach based on evaluation by non-contrast TCMS and by CO2 aortoiliac angiography (anatomical screening).
High risk of rupture of the ring or significant residual paravalvular leak due to important calcification of the left ventricular outflow tract.
High risk of coronary occlusion (height of the coronary ostium <10 mm with narrow SOV: <1 mm greater than the size of the bioprosthesis) defined by imaging methods.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fabio S Brito, PHDq
Phone
+551126615286
Email
fabio.cardiol@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fábio S Brito Jr., PhD
Organizational Affiliation
Structural Heart Disease - Interventional cardiologist
Official's Role
Principal Investigator
Facility Information:
Facility Name
Heart Institute - InCor. University of Sao Paulo Medical School
City
São Paulo
ZIP/Postal Code
05403-900
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fábio S Brito Jr., PhD
Phone
+5511266153286
Email
fabio.cardiol@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Transcatheter Implantation of Aortic Bioprosthesis Without the Use of Iodinated Contrast in Patients With Chronic Kidney Disease
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