Stenosis; ValveNCT04581694
Transcatheter Implantation of Aortic Bioprosthesis Without the Use of Iodinated Contrast in Patients With Chronic Kidney Disease
A study testing TAVI without contrast in people with Stenosis; Valve and Renal Failure, run by University of Sao Paulo General Hospital at 1 site in Brazil.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stenosis; Valve, Renal Failure, Renal Insufficiency
- What is being tested?
- TAVI without contrast
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Dec 2020to 1 Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Heart Institute - InCor. University of Sao Paulo Medical School
São Paulo, 05403-900
Fábio S Brito Jr., PhD, +5511266153286, fabio.cardiol@gmail.com
About this study
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.
Read the 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.
- Conditions
- Stenosis; Valve, Renal Failure, Renal Insufficiency
- Being tested
- TAVI without contrast
- Medical subject headings
- Constriction, Pathologic, Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAVI without contrastDiagnostic test
TAVI without contrast
| Study group | Role | What they receive |
|---|---|---|
| TAVI without contrast | Experimental | Not described Receives: Diagnostic Test: TAVI without contrast |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 7 days
Secondary outcomes (4)
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.
Measured: 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).
Measured: 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).
- 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)
Measured: 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)
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2020
- Study start1 Dec 2020
- Primary completion1 Apr 2022 (estimated)
- Study completion1 Apr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stenosis; ValveStudies of the same condition, open and under way.
- More trials run by University of Sao Paulo General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fábio Sândoli de Brito Júnior, University of Sao Paulo General Hospital
- Investigators
- Fábio S Brito Jr., PhD, Principal investigator, Structural Heart Disease - Interventional cardiologist
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04581694
- Sponsor's protocol ID
- FábioSândoli
- Status last verified
- Mar 2021
- First submitted
- 25 Sep 2020
- Last updated
- 16 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcatheter Implantation of Aortic Bioprosthesis Without the Use of Iodinated Contrast in Patients With Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT04581694
- Acronym / sponsor ID
- FábioSândoli
- Conditions
- Stenosis; Valve, Renal Failure, Renal Insufficiency
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 1 Apr 2022 (estimated)
- Study completion
- 1 Apr 2022 (estimated)
- First posted
- 9 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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).
| Arm | Type | Receives |
|---|---|---|
| TAVI without contrast | Experimental | Diagnostic Test: TAVI without contrast |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (18 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TAVI without contrastTAVI without contrast | Diagnostic test | TAVI without contrast |
Primary outcome
Pilot Phase: Early safety at 30 days - (VARC-2 criteria)
Time frame: 30 days
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
Time frame: 7 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.
4 secondary outcomes
Pilot phase: Accuracy in choosing the size of the bioprosthesis.
Time frame: Procedure - 1 day
Pilot phase: Device success (VARC-2 criteria)
Time frame: Procedure - 1 day
Zero Contrast phase: Device success (VARC-2 criteria)
Time frame: Procedure - 1 day
Zero Contrast phase: Early safety at 30 days - (VARC-2 criteria)
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fábio S Brito Jr., PhD principal investigator
Structural Heart Disease - Interventional cardiologist
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TAVI without contrast in people with Stenosis; Valve and Renal Failure, run by University of Sao Paulo General Hospital at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fabio S Brito, PHDq (+551126615286, fabio.cardiol@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pilot Phase: Early safety at 30 days - (VARC-2 criteria) (time frame: 30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2021.