RecruitingNot ApplicableNCT05496998

Transcatheter Mitral Valve Replacement in Patients With Severe Symptomatic Mitral Regurgitation - APOLLO-EU Trial

Transcatheter Mitral Valve Replacement With the Medtronic Intrepid™ TMVR Transfemoral System in Patients With Severe Symptomatic Mitral Regurgitation - APOLLO-EU Trial

Sponsor

Medtronic Cardiovascular

Enrollment

400 participants

Start Date

Feb 7, 2023

Study Type

INTERVENTIONAL

Conditions

Mitral Regurgitation

Summary

Evaluate the safety and efficacy of Medtronic Intrepid™ TMVR TF System in patients with moderate-to-severe or severe symptomatic mitral regurgitation, or moderate symptomatic mitral regurgitation combined with mitral stenosis in the presence of MAC who, by agreement of the local site multidisciplinary heart team experienced in mitral valve therapies, are unsuitable for treatment with approved transcatheter repair or surgical mitral valve intervention.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a new minimally invasive procedure to replace a leaky heart valve (the mitral valve) using a device called the Medtronic Intrepid system. Instead of open-heart surgery, the new valve is delivered through a catheter (a thin tube) inserted through the leg — called a transcatheter approach. This is for patients who are not suitable candidates for standard surgery or repair. **You may be eligible if...** - You have moderate-to-severe or severe mitral valve leakage (mitral regurgitation) causing symptoms - Your heart care team has decided you are not a good candidate for standard surgery or current repair procedures - Your anatomy is compatible with the device **You may NOT be eligible if...** - Your expected survival is less than 2 years - You already have a surgically or catheter-implanted mitral valve - Your heart pumping function (ejection fraction) is below 25% - You have end-stage kidney disease, liver failure, or significant frailty - You are in an emergency situation or hemodynamically unstable 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

DEVICEMedtronic Intrepid™ TMVR TF System

Patients with moderate-to-severe or severe symptomatic mitral regurgitation, or moderate symptomatic mitral regurgitation combined with mitral stenosis in the presence of MAC will have a Transcatheter Mitral Valve Replacement with the Medtronic Intrepid™ TMVR Transfemoral System

Locations(37)

Aarhus University Hospital

Aarhus, Denmark

Rigshospitalet

Copenhagen, Denmark

Odense University Hospital

Odense, Denmark

Clinique Pasteur

Toulouse, Cedex 03, France

CHU Bordeaux

Bordeaux, Pessac Cedex, France

Henri-Mondor University Hospital

Créteil, France

CHU Timone

Marseille, France

CHU de Nantes

Nantes, France

CHU Rennes - Pontchaillou Hospital

Rennes, France

Centre Cardiologique du Nord (CCN)

Saint-Denis, France

CHRU de Tours

Tours, France

Heart and Diabetes Center NRW

Bad Oeynhausen, Germany

Deutsches Herzzentrum der Charité (DHZC)

Berlin, Germany

Universitätsklinikum Bonn

Bonn, Germany

Universitäres Herz- und Gefäßzentrum Hamburg

Hamburg, Germany

Herzzentrum Leipzig

Leipzig, Germany

University Medical Center Mainz

Mainz, Germany

Deutsches Herzzentrum München

München, Germany

LMU Clinic of University Hospital München

München, Germany

Universitätsklinikum Ulm

Ulm, Germany

Azienda Ospedaliero - Universitaria di Bologna - Policlinico S.Orsola Malpighi

Bologna, Italy

Azienda Ospedaliera Spedali Civili di Brescia

Brescia, Italy

Ospedale San Raffaele

Milan, Italy

Azienda Ospedaliero Universitaria Pisana

Pisa, Italy

IRCCS Policlinico San Donato

San Donato Milanese, Italy

Catharina Hospital

Eindhoven, Netherlands

St. Antonius Hospital

Nieuwegein, Netherlands

Erasmus University Medical Center

Rotterdam, Netherlands

Hospital Clínic de Barcelona

Barcelona, Spain

Hospital Universitario Ramón y Cajal

Madrid, Spain

Central University Hospital of Asturias

Oviedo, Spain

University Hospital Alvaro Cunqueiro

Vigo, Spain

Universitätsspital Bern

Bern, Switzerland

University Hospitals Sussex NHS Foundation Trust

Brighton, United Kingdom

Leeds General Infirmary

Leeds, United Kingdom

Guys & St Thomas NHS Foundation Trust - St Thomas Hospital London

London, United Kingdom

Royal Brompton Hospital

London, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT05496998

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