RecruitingNCT06569602

Real World European Investigation of Safety and Clinical Efficacy of the EVOQUE System (TRISCEND III EU)

Edwards EVOQUE Transcatheter Tricuspid Valve Replacement: Real World European Investigation of Safety and Clinical Efficacy Using a Novel Device

Sponsor

Edwards Lifesciences

Enrollment

500 participants

Start Date

Oct 1, 2024

Study Type

OBSERVATIONAL

Conditions

Cardiovascular Diseases Tricuspid Valve Regurgitation Heart Valve Diseases

Summary

This is a prospective, single-arm, multi-center, real-world study of an the Edwards EVOQUE system.

Eligibility

Plain Language Summary

Simplified for easier understanding

This real-world study tracks the safety and clinical outcomes of patients who have received the EVOQUE transcatheter tricuspid valve replacement system across European medical centers. The tricuspid valve is on the right side of the heart; when it leaks severely, the EVOQUE device can replace it without open heart surgery. **You may be eligible if:** - Your heart team has already decided that you are a suitable candidate for transcatheter tricuspid valve replacement with the EVOQUE system, based on the current approved guidelines - You are willing to attend follow-up appointments - You are able to provide written informed consent **You may NOT be eligible if:** - You are currently enrolled in another interventional drug, biologic, or device clinical trial that has not yet finished - You are considered a vulnerable patient unable to make independent decisions Talk to your doctor to see if this trial is right for you.

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

DEVICETranscatheter Tricuspid Valve Replacement

Replacement of the tricuspid valve through a transcatheter approach

Locations(23)

Zentralklinik Bad Berka GmbH

Bad Berka, Germany

Kerckhoff-Klinik GmbH Bad Nauheim

Bad Nauheim, Germany

Rhoen-Klinikum Campus - Bad Neustadt

Bad Neustadt an der Saale, Germany

Herz-und Diabeteszentrum NRW

Bad Oeynhausen, Germany

Deutsches Herzzentrum der Charité (DHZC)

Berlin, Germany

Herzzentrum Universitaet Bonn

Bonn, Germany

St. Johannes Hospital Dortmund

Dortmund, Germany

Universitatsklinik Essen

Essen, Germany

Asklepios Klinik St Georg Hamburg

Hamburg, Germany

Universitaetsklinikum Schleswig Holstein Campus Kiel

Kiel, Germany

Leipzig Herzzentrum

Leipzig, Germany

Universitaetsklinikum Schleswig Holstein Campus Lubeck

Lübeck, Germany

Johannes Gutenberg Universitaet Mainz

Mainz, Germany

Deutsches Herzzentrum Muenchen (DHM)

Munich, Germany

Klinikum der Universitaet Muenchen - Grosshadern

Munich, Germany

Universitaetsklinikum Tuebingen

Tübingen, Germany

Universitaetsklinikum Ulm

Ulm, Germany

Hygeia Hospital - Athens

Athens, Greece

Centro Cardiologico Monzino Milano

Milan, Italy

Hospital Clinico San Carlos - Madrid

Madrid, Spain

University Hospital Ramon Y Cajal Madrid

Madrid, Spain

Inselspital

Bern, Switzerland

Oxford John Radcliffe Hospital

Oxford, United Kingdom

View Full Details on ClinicalTrials.gov

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