Treatment of Aortic Stenosis in Brazil: Cost-Utility Analysis of TAVI vs SAVR
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Aortic Stenosis
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Randomized controlled trialMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 70 years and 125 years
- Gender
- Both males and females
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) h...
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.
Tracking Information
- NCT #
- NCT04067089
- Collaborators
- Not Provided
- Investigators
- Study Chair: Alexandre A Abizaid, MD, PhD Hospital do Coracao Study Chair: Fabio Jatene, MD, PhD Hospital do Coracao Principal Investigator: Dimytri A Siqueira, MD PhD Hospital do Coracao Study Chair: Paulo P Fernandes, Md, PhD Hospital do Coracao
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