RecruitingNot ApplicableNCT04861805

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

A Two -Stage First in Human (FIH) Feasibility / Pivotal Study of the Vienna Aortic Valve SE System

Sponsor

P+F Products + Features GmbH

Enrollment

267 participants

Start Date

Jul 3, 2023

Study Type

INTERVENTIONAL

Conditions

Symptomatic Aortic Stenosis

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.

Eligibility

Min Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Vienna Aortic Valve SE System for people with symptomatic aortic stenosis. The study is currently recruiting participants at 31 locations. People eligible for this study include aged 65 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DEVICEVienna Aortic Valve SE System

Vienna Aortic Valve SE system for TAVI.

Locations(31)

Hospital Privado Sur (FUMEBA)

Bahía Blanca, Argentina

Fundación Favaloro

Buenos Aires, Argentina

Hospital Italiano De Buenos Aires

Buenos Aires, Argentina

Instituto Nacional de Cardiologia

Rio de Janeiro, Rio de Janeiro, Brazil

Escola Paulista de Medicina da UNIFESP

São Paulo, São Paulo, Brazil

Instituto Estadual De Cardiologia Aloysio De Castro

Rio de Janeiro, Brazil

Instituto Dante Pazzanese De Cardiologia

São Paulo, Brazil

Instituto Do Coração (InCor) De São Paulo

São Paulo, Brazil

Hospital Del Torax De Santiago

Santiago, Chile

Hospital Clínico San Borja Arriarán

Santiago, Chile

Hospital Las Higueras - Talcahuano

Talcahuano, Chile

Narayana Health, Multispeciality Hospital

Bangalore, India

Medanta - The Medicity Multi-Speciality Hospital

Gurgaon, India

RHL- Rajasthan Hospital

Jaipur, India

LISIE Hospital

Kochi, India

Christian Medical College Hospital

Vellore, India

Hospital of Lithuanian University of Health Sciences Kauno klinikos

Kaunas, Kaunas County, Lithuania

Hospital Santa Marta

Lisbon, Lisbon District, Portugal

Hospital Santa Maria

Lisbon, Lisbon District, Portugal

Hospital de Santa Cruz

Carnaxide, Portugal

Unidade Local de Saúde de Gaia e Espinho

Vila Nova de Gaia, Portugal

Hospital do Espírito Santo de Évora

Evora, Évora District, Portugal

Hospital Clinic De Barcelona

Barcelona, Barcelona, Spain

Hospital de la Santa Creu i Sant Pau

Barcelona, Barcelona, Spain

Hospital Universitario Ramón y Cajal

Madrid, Madrid, Spain

Hospital Clinico San Carlos

Madrid, Madrid, Spain

University Clinical Hospital of Valladolid

Valladolid, Valladolid, Spain

Hospital Puerta De Hierro

Majadahonda, Spain

Hospital Virgen De La Victoria

Málaga, Spain

Hospital Universitario Central de Asturias

Oviedo, Spain

İ.A.Ü. VM Medical Park Florya Hospital

Istanbul, Istanbul, Turkey (Türkiye)

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT04861805

Related Trials

Structured Shared Decision Making for Patients Undergoing SAVR or TAVR

NCT057111861 location

Transcatheter Aortic Valve Replacement Single Center Registry in Chinese Population

NCT028032941 location