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

Aortic Stenosis Clinical Trial

Official title:
Prospective, Randomized, Cost-utility Analysis of Transcatheter Aortic Valve Implantation Versus Surgical Aortic Valve Replacement in Brazil

Clinical 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).

Clinical Trial 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

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04067089
Study type Interventional
Source Hospital do Coracao
Contact
Status Active, not recruiting
Phase N/A
Start date December 10, 2018
Completion date December 31, 2023
View Details
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