NCT04067089

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 126 (estimated)
• Sponsor: Hospital do Coracao · Academic / Other
• Sex: All
• Age: 70 Years
• Healthy volunteers: Not accepted

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).

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2018-12-10
• Primary completion: 2023-09-13
• Completion: 2023-12-31
• First posted: 2019-08-26
• Last updated: 2023-03-02

Locations

1 site across 1 country: Brazil