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ACTIVE NOT RECRUITING
NCT05531578
NA

Transfemoral Implant of Inovare® Transcatheter Valve

Sponsor: Braile Biomedica Ind. Com. e Repr. Ltda.

View on ClinicalTrials.gov

Summary

Clinical trial to evaluate the early safety and efficacy of the transfemoral implant of Inovare® Transcatheter Valve for the treatment of patients with severe degenerative aortic stenosis and high surgical risk.

Official title: Transfemoral Implant of Inovare® Transcatheter Valve - Clinical Trial of Feasibility and Safety and Efficacy Verification

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2020-09-11

Completion Date

2028-12-30

Last Updated

2024-01-11

Healthy Volunteers

No

Interventions

DEVICE

INOVARE® Transcatheter Valve, NexusCath Delivery System, Aureus Expandable Introducer, Balloon Catheter for Pre-Dilation and Compression Device (Crimper)

Transfemoral implantation of the INOVARE® transcatheter valve

Locations (4)

Fundação Faculdade Regional de Medicina de São José do Rio Preto

São José do Rio Preto, Brazil

INCOR - Instituto do Coração do Hospital das Clínicas da FMUSP

São Paulo, Brazil

Instituto Dante Pazzanese de Cardiologia

São Paulo, Brazil

Universidade Federal de São Paulo

São Paulo, Brazil