Pivotal Study of the Vienna Transcatheter Self Expandable Aortic Valve SE System

Summary

This is a prospective, single arm, multicenter study in an cohort of up to 267 patients (up to 100 Roll-ins and 167 patients implanted per protocol) symptomatic patients with severe aortic stenosis who will be followed up for up to 5 years.

Conditions

• Symptomatic Aortic Stenosis

Interventions

DEVICE

Vienna Aortic Valve SE System

Vienna Aortic Valve SE system for TAVI.

Sponsors & Collaborators

• Meditrial USA Inc.

  collaborator INDUSTRY

• P+F Products + Features GmbH

  lead INDUSTRY

Principal Investigators

• Alexandre Abizaid, MD · Instituto do Coração (InCor) de São Paulo

• Carla Agatiello, MD · Hospital Italiano de Buenos Aires

• Alejandro Alvarez Iorio, MD · Hospital Privado Sur (FUMEBA)

• Ignacio J Amat-Santos, MD · University Clinical Hospital of Valladolid

• Rimantas Benetis, MD · Lithuanian University of Health Sciences

• Pedro Braga, MD · Unidade Local de Saúde de Gaia e Espinho

• Juan Horacio A Briales, MD · Hospital Virgen de la Victoria

• João Brito, MD · Hospital de Santa Cruz

• Duarte Cacela, MD · Hospital Santa Marta

• Adriano M Caixeta, MD · Escola Paulista de Medicina da UNIFESP

• Praveen Chandra, MD · Medanta - The Medicity Hospital

• Christian Dauvergne, MD · Hospital del Tórax de Santiago

• Pedro C Ferreira, MD · Hospital Santa Maria

• John Jose E, MD · Christian Medical College Hospital

• Rony Mathew Kadavil, MD · Lisie Hospital

• Gabriel Maluenda, MD · Hospital Clínico San Borja Arriarán

• Cesar R Medeiros, MD · Instituto Nacional de Cardiologia

• Oscar Mendiz, MD · Fundación Favaloro

• Sanjay Mehrotra, MD · Narayana Health Hospital

• Marcio J Montenegro Da Costa, MD · Instituto Estadual de Cardiologia Aloysio de Castro

• Cesar Morís de La Tassa, MD · Hospital Universitario Central de Asturias

• Luis Nombela, MD · Hospital San Carlos, Madrid

• Juan Oteo, MD · Hospital Puerta De Hierro

• Lino MD Patrício, MD · Hospital do Espírito Santo de Évora

• Osvaldo Perez, MD · Hospital Las Higueras - Talcahuano

• Ravinder Singh Rao, MD · RHL - Rajasthan Hospital

• Ángel S Recalde, MD · Hospital Universitario Ramón y Cajal

• Ander Regueiro, MD · Hospital Clinic of Barcelona

• Lluis A Serra, MD · Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

• Dimytri Siqueira, MD · Instituto Dante Pazzanese de Cardiologia

• Hakan Ucar, MD · İ.A.Ü. VM Medical Park Florya Hospital

Study Design

Allocation

NA

Purpose

OTHER

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-07-03

Primary Completion

2025-10-31

Completion

2030-10-31

Countries

• Argentina
• Brazil
• Chile
• India
• Lithuania
• Portugal
• Spain
• Turkey (Türkiye)

Study Locations