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Treatment of Aortic Stenosis in Brazil: Cost-Utility Analysis of TAVI vs SAVR

NCT04067089 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 126

Last updated 2023-03-02

No results posted yet for this study

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).

Conditions

  • Aortic Stenosis

Interventions

PROCEDURE

TAVR - Transcatheter aortic valve replacement

TAVR - Transcatheter aortic valve replacement with Acurate Neo bioprosthesis (Boston Scientific) using minimalist approach

PROCEDURE

Surgical aortic valve replacement

Surgical aortic valve replacement

Sponsors & Collaborators

  • Hospital do Coracao

    lead OTHER

Principal Investigators

  • Alexandre A Abizaid, MD, PhD · Hospital do Coracao

  • Fabio Jatene, MD, PhD · Hospital do Coracao

  • Dimytri A Siqueira, MD PhD · Hospital do Coracao

  • Paulo P Fernandes, Md, PhD · Hospital do Coracao

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-10
Primary Completion
2023-09-13
Completion
2023-12-31

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 NCT04067089 on ClinicalTrials.gov