RecruitingNot ApplicableNCT06049654

Comparison of Allegra vs Sapien Transcatheter Aortic Valves in Valve-In-Valve Indication

Clinical Trial of the Results of Allegra vs Sapien Transcatheter Aortic Valves in Valve-In-Valve Indication

Sponsor

Fundación EPIC

Enrollment

104 participants

Start Date

Feb 1, 2024

Study Type

INTERVENTIONAL

Conditions

Aortic Valve Stenosis Structural Valve Deterioration

Summary

The VIVALL-2 study is a randomized trial to compare the self-expandable supra-annular Allegra and the balloon-expandable intra-annular Edwards transcatheter valve systems in patients with degenerated biological aortic surgical valve.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called EDWARDS SAPIEN 3 or SAPIEN ULTRA SYSTEM and a medical device called NVT ALLEGRA TAVI System TF for people with aortic valve stenosis and structural valve deterioration. The study is currently recruiting participants at 11 locations. People eligible for this study include aged 18 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.

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Interventions

DEVICENVT ALLEGRA TAVI System TF

Transcatheter aortic valve implantation of a NVT ALLEGRA TAVI System TF in patients with severe haemodynamical valve deterioration of a biological aortic valve implanted surgically

DEVICEEDWARDS SAPIEN 3 or SAPIEN ULTRA SYSTEM

Transcatheter aortic valve implantation of an EDWARDS SAPIEN 3 SYSTEM in patients with severe haemodynamical valve deterioration of a biological aortic valve implanted surgically

Locations(11)

Azienda Ospedaliero- Universitaria di Alessandria

Alessandria, Italy

Azienda Ospedaliera di Perugia

Perugia, Italy

Hospital Universitari de Bellvitge

L'Hospitalet de Llobregat, Spain

Hospital Clinico San Carlos

Madrid, Spain

Hospital Universitario de La Paz

Madrid, Spain

Hospital Universitario Puerta De Hierro

Majadahonda, Spain

Hospital Clínico Universitario de Salamanca

Salamanca, Spain

Hospital Universitari I Politècnic de La Fe

Valencia, Spain

Manchester University NHS Foundation Trust

Manchester, United Kingdom

Freeman Hospital

Newcastle, United Kingdom

Morriston Hospital, Swansea

Swansea, United Kingdom

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NCT06049654

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