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Transfemoral Implant of Inovare® Transcatheter Valve

NCT05531578 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2024-01-11

No results posted yet for this study

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.

Conditions

  • Aortic Valve Stenosis

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

Sponsors & Collaborators

  • Braile Biomedica Ind. Com. e Repr. Ltda.

    lead INDUSTRY

Principal Investigators

  • José Honório de Almeida Palma da Fonseca, Dr · InCor Heart Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-11
Primary Completion
2024-02-20
Completion
2028-12-30

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 NCT05531578 on ClinicalTrials.gov