Aortic StenosisTEAm-BRNCT04067089
Treatment of Aortic Stenosis in Brazil: Cost-Utility Analysis of TAVI vs SAVR
A study testing TAVR - Transcatheter aortic valve replacement and Surgical aortic valve replacement in people with Aortic Stenosis, run by Hospital do Coracao at 1 site in Brazil.
Trial summary
TEAM-Br is a randomized, prospective, cost-utility study comparing transcatheter aortic valve implantation (TAVI) versus surgical aortic vale replacement in Brazil. The study is sponsored by the national Minister of Health, through PROADI-SUS (Programa de Apoio ao Desenvolvimento Institucional do SUS). Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Aortic Stenosis
- What is being tested?
- TAVR - Transcatheter aortic valve replacement and Surgical aortic valve replacement
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 siteBrazil
- Study dates
- 10 Dec 2018to 31 Dec 2023
- 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 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Age > 70 years;
- Symptoms of heart failure NYHA class > II;
- Severe aortic stenosis (as defined by echocardiography: mean gradient >40 mmHg or jet velocity greater than 4.0 m/s or an initial aortic valve area of < 1.0 cm2)
- Heart team (including examining cardiac surgeon) agree on eligibility including assessment that TAVR or SAVR is appropriate;
- The study patient or the study patient's legal representative informed of the nature of the study, agreed to its provisions and provided written informed consent as approved by the Institutional Review Board (IRB) center;
- The study patient agreed to comply with all required post-procedure follow-up visits including visits through 1 month and 1 year;
- Heart team agreed (a priori) on treatment strategy for concomitant coronary disease (if present);
- Patient agreed to undergo surgical aortic valve replacement (SAVR) if randomized to control treatment.
Who cannot join
- Heart Team assessment of inoperability (including examining cardiac surgeon);
- Hostile chest
- Evidence of an acute myocardial infarction ≤ 1 month (30 days) before the intended treatment [defined as: Q wave MI, or non-Q wave MI with total CK elevation of CK-MB ≥ twice normal in the presence of MB elevation and/or troponin level elevation (WHO definition)];
- Concomitant severe valvular disease (mitral, tricuspid or pulmonic) requiring surgical intervention;
- Preexisting mechanical or bioprosthetic aortic valve with dysfunction;
- Complex coronary artery disease: unprotected left main coronary artery, Syntax score > 32 (in the absence of prior revascularization);
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- Any therapeutic invasive cardiac procedure resulting in a permanent implant that is performed within 30 days of the index procedure (unless part of planned strategy for treatment of concomitant coronary artery disease). Implantation of a permanent pacemaker is not an exclusion criteria;
- Leukopenia (WBC < 3000 cell/mL), acute anemia (Hgb < 9 g/dL), thrombocytopenia (Plt < 50,000 cell/mL);
- Hypertrophic cardiomyopathy with or without obstruction (HOCM);
- Severe ventricular dysfunction with LVEF < 20%;
- Echocardiographic evidence of intracardiac mass, thrombus or vegetation;
- Active upper GI bleeding within 3 months (90 days) prior to procedure;
- A known contraindication or hypersensitivity to all anticoagulation regimens, or inability to be anticoagulated for the study procedure;
- Clinically (by neurologist) or neuroimaging confirmed stroke or transient ischemic attack (TIA) within 6 months (180 days) of the procedure;
- Renal insufficiency (creatinine > 3.0 mg/dL) and/or renal replacement therapy at the time of screening;
- Estimated life expectancy < 24 months (730 days) due to carcinomas, chronic liver disease, chronic renal disease or chronic end stage pulmonary disease;
- Currently participating in an investigational drug or another device study;
- Active bacterial endocarditis within 6 months (180 days) of procedure;
- Patient refuses surgery for aortic valve replacement.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective, Randomized, Cost-utility Analysis of Transcatheter Aortic Valve Implantation Versus Surgical Aortic Valve Replacement in Brazil
TEAM-Br is a randomized, prospective, cost-utility study comparing transcatheter aortic valve implantation (TAVI) versus surgical aortic vale replacement in Brazil.
The study is sponsored by the national Minister of Health, through PROADI-SUS (Programa de Apoio ao Desenvolvimento Institucional do SUS).
Read the detailed description
Transcatheter aortic valve implantation has been shown to be non-inferior to surgical aortic valve replacement in patients with severe aortic stenosis at high, intermediate and low surgical risk. In recent years, a concept of a simplified and optimized TAVR procedure (known as minimalist approach) has led experienced centers to perform the majority of these procedures using conscious sedation and local anesthesia only. From a clinical perspective, this approach is associated with better and faster recovery and mobilization, reduced need for a prolonged intensive care unit (ICU) stay and faster hospital discharge, as compared to general anesthesia.
The cost-effectiveness of minimalist TAVR strategy - as compared to surgery - in Brazil is uncertain. Our objective is to conduct a cost-utility analysis comparing minimalist transcatheter aortic valve implantation with surgical aortic valve replacement in patients with severe aortic stenosis.
- Conditions
- Aortic Stenosis
- Being tested
- TAVR - Transcatheter aortic valve replacement, Surgical aortic valve replacement
- Keywords
- aortic stenosis
- Medical subject headings
- Aortic Valve Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAVR - Transcatheter aortic valve replacementProcedure or surgery
Also called TAVR
TAVR - Transcatheter aortic valve replacement with Acurate Neo bioprosthesis (Boston Scientific) using minimalist approach
Surgical aortic valve replacementProcedure or surgery
Also called SAVR
Surgical aortic valve replacement
| Study group | Role | What they receive |
|---|---|---|
| TAVR - Transcatheter aortic valve replacement | Experimental | TAVR - Transcatheter aortic valve replacement with Acurate Neo bioprosthesis (Boston Scientific) using minimalist approach Receives: Procedure: TAVR - Transcatheter aortic valve replacement |
| Surgical aortic valve replacement | Active comparator | Surgical aortic valve replacement Receives: Procedure: Surgical aortic valve replacement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cost-utility of minimalist TAVR as compared to SAVR
Quality-adjusted life-years (QALYs). Quality of life will be assessed by EuroQol 5D.
Measured: 1 year
Cost-utility of minimalist TAVR as compared to SAVR
Incremental cost-effectiveness ratio (ICER)
Measured: 1 year
Secondary outcomes (1)
Clinical outcomes
All-cause mortality, cardiovascular mortality, disabling stroke, acute renal failure, bleeding, major vascular complications, atrial fibrillation and permanent pacemaker implantation
Measured: 30 days and 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2019
- Study start10 Dec 2018
- Primary completion13 Sep 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic StenosisStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 126 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital do Coracao
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alexandre A Abizaid, MD, PhD, Study chair, Hospital do CoracaoFabio Jatene, MD, PhD, Study chair, Hospital do CoracaoDimytri A Siqueira, MD PhD, Principal investigator, Hospital do CoracaoPaulo P Fernandes, Md, PhD, Study chair, Hospital do Coracao
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04067089
- Sponsor's protocol ID
- TEAm-BR
- Acronym
- TEAm-BR
- Status last verified
- Mar 2023
- First submitted
- 11 Aug 2019
- Last updated
- 2 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Reproducible Research Statement:We will share the database containing de-identified individual participant data, data dictionary documentation, statistical analysis plan, and analysis code. Beginning 6 months and ending 24 months following article publication, the trial steering committee will evaluate proposals of studies accompanied by a statistical analysis plan and may grant access to the data for approved proposals. After 24 months, the database and accompanying documents will be publicly available in an institutional data repository (http://www.hcor.com.br).
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Randomized, Cost-utility Analysis of Transcatheter Aortic Valve Implantation Versus Surgical Aortic Valve Replacement in Brazil
- ClinicalTrials.gov ID
- NCT04067089
- Acronym / sponsor ID
- TEAm-BR / TEAm-BR
- Conditions
- Aortic Stenosis
- Keywords
- aortic stenosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 126 participants (estimated)
- Lead sponsor
- Hospital do CoracaoUniversity, hospital or other
- Study start
- 10 Dec 2018 (actual)
- Primary completion
- 13 Sep 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 26 Aug 2019 (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.
TEAM-Br is a randomized, prospective, cost-utility study comparing transcatheter aortic valve implantation (TAVI) versus surgical aortic vale replacement in Brazil.
The study is sponsored by the national Minister of Health, through PROADI-SUS (Programa de Apoio ao Desenvolvimento Institucional do SUS).
Detailed description
Transcatheter aortic valve implantation has been shown to be non-inferior to surgical aortic valve replacement in patients with severe aortic stenosis at high, intermediate and low surgical risk. In recent years, a concept of a simplified and optimized TAVR procedure (known as minimalist approach) has led experienced centers to perform the majority of these procedures using conscious sedation and local anesthesia only. From a clinical perspective, this approach is associated with better and faster recovery and mobilization, reduced need for a prolonged intensive care unit (ICU) stay and faster hospital discharge, as compared to general anesthesia.
The cost-effectiveness of minimalist TAVR strategy - as compared to surgery - in Brazil is uncertain. Our objective is to conduct a cost-utility analysis comparing minimalist transcatheter aortic valve implantation with surgical aortic valve replacement in patients with severe aortic stenosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| TAVR - Transcatheter aortic valve replacement | Experimental | Procedure: TAVR - Transcatheter aortic valve replacementTAVR - Transcatheter aortic valve replacement with Acurate Neo bioprosthesis (Boston Scientific) using minimalist approach |
| Surgical aortic valve replacement | Active comparator | Procedure: Surgical aortic valve replacementSurgical aortic valve replacement |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (8 listed)
- Age > 70 years;
- Symptoms of heart failure NYHA class > II;
- Severe aortic stenosis (as defined by echocardiography: mean gradient >40 mmHg or jet velocity greater than 4.0 m/s or an initial aortic valve area of < 1.0 cm2)
- Heart team (including examining cardiac surgeon) agree on eligibility including assessment that TAVR or SAVR is appropriate;
- The study patient or the study patient's legal representative informed of the nature of the study, agreed to its provisions and provided written informed consent as approved by the Institutional Review Board (IRB) center;
Key exclusion criteria (19 listed)
- Heart Team assessment of inoperability (including examining cardiac surgeon);
- Hostile chest
- Evidence of an acute myocardial infarction ≤ 1 month (30 days) before the intended treatment [defined as: Q wave MI, or non-Q wave MI with total CK elevation of CK-MB ≥ twice normal in the presence of MB elevation and/or troponin level elevation (WHO definition)];
- Concomitant severe valvular disease (mitral, tricuspid or pulmonic) requiring surgical intervention;
- Preexisting mechanical or bioprosthetic aortic valve with dysfunction;
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 |
|---|---|---|
| TAVR - Transcatheter aortic valve replacementAlso: TAVRTAVR - Transcatheter aortic valve replacement with Acurate Neo bioprosthesis (Boston Scientific) using minimalist approach | Procedure or surgery | TAVR - Transcatheter aortic valve replacement |
| Surgical aortic valve replacementAlso: SAVRSurgical aortic valve replacement | Procedure or surgery | Surgical aortic valve replacement |
Primary outcome
Cost-utility of minimalist TAVR as compared to SAVR
Time frame: 1 year
Quality-adjusted life-years (QALYs). Quality of life will be assessed by EuroQol 5D.
Cost-utility of minimalist TAVR as compared to SAVR
Time frame: 1 year
Incremental cost-effectiveness ratio (ICER)
1 secondary outcome
Clinical outcomes
Time frame: 30 days and 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2023.
- Individual participant dataSharing planned: Yes. Reproducible Research Statement:We will share the database containing de-identified individual participant data, data dictionary documentation, statistical analysis plan, and analysis code. Beginning 6 months and ending 24 months following article publication, the trial steering committee will evaluate proposals of studies accompanied by a statistical analysis plan and may grant access to the data for approved proposals. After 24 months, the database and accompanying documents will be publicly available in an institutional data repository (http://www.hcor.com.br).
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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.
Alexandre A Abizaid, MD, PhD study chair
Hospital do Coracao
Fabio Jatene, MD, PhD study chair
Hospital do Coracao
Dimytri A Siqueira, MD PhD principal investigator
Hospital do Coracao
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TAVR - Transcatheter aortic valve replacement and Surgical aortic valve replacement in people with Aortic Stenosis, run by Hospital do Coracao 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 8 inclusion and 19 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 2 Mar 2023. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cost-utility of minimalist TAVR as compared to SAVR (time frame: 1 year). 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 2 Mar 2023.