RecruitingNot ApplicableNCT04029363

Expanded Study of the HighLife 28mm Trans-septal Trans-catheter Mitral Valve in Patients With Moderate-severe or Severe Mitral Regurgitation and at High Surgical Risk


Sponsor

HighLife SAS

Enrollment

120 participants

Start Date

May 28, 2019

Study Type

INTERVENTIONAL

Conditions

Summary

to evaluate the safety and performance of the HighLife 28mm transcatheter, trans-septal Mitral Valve in patients with moderate-severe or severe mitral regurgitation who are at high risk for surgical treatment.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called HighLife Transcatheter Mitral Valve Replacement for people with mitral regurgitation. The study is currently recruiting participants at 50 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

DEVICEHighLife Transcatheter Mitral Valve Replacement

Transcatheter Mitral Valve Replacement


Locations(50)

St. Vincent's Hospital - Sydney

Darlinghurst, New South Wales, Australia

John Hunter Hospital

Newcastle, New South Wales, Australia

Macquarie University Hospital

Sydney, New South Wales, Australia

The Wesley Hospital

Auchenflower, Queensland, Australia

St. Andrew's Hospital

Adelaide, Australia

Princess Alexandra Hospital

Brisbane, Australia

Warringal Hospital

Heidelberg, Australia

The Alfred Hospital

Melbourne, Australia

John Hunter Hospital

Newcastle, Australia

Mount Hospital

Perth, Australia

North Shore Private Hospital

Sydney, Australia

ZNA Middelheim

Antwerp, Belgium

AZ Sint-Jan

Bruges, Belgium

UZ Leuven

Leuven, Belgium

Rangueil University Hospital

Toulouse, Toulouse, France

CHU Lille

Lille, France

Medipole Lyon-Villeurbanne

Lyon, France

Hopital Prive - Jacques Cartier

Massy, France

Centre Hospitalo-Universitaire de Nantes

Nantes, France

European Hospital George Pompidou

Paris, France

CHU Bordeaux

Pessac, France

CHU de Rennes

Rennes, France

Centr Cardiologiqque du Nord

Saint-Denis, France

CHRU Strasbourg

Strasbourg, France

Clinque Pasteur

Toulouse, France

Rangueil University Hospital

Toulouse, France

University Heart Center Freiburg - Bad Krozingen

Bad Krozingen, Germany

Universitaetsklinikum Bonn

Bonn, Germany

Heart Center, University Hospital Dresden

Dresden, Germany

Universitatsklink Hamburg-Eppendorf

Hamburg, Germany

Mediinisches Versorgungszentrum

Hamburg, Germany

University Hospital Heidelberg

Heidelberg, Germany

Herzentrum Leipzig

Leipzig, Germany

Deutsches Herzzentrum Munchen

Munich, Germany

University Medicine Dept of Cardiology

Rostock, Germany

University Hospital Ulm

Ulm, Germany

Medical University of Gdansk

Gdansk, Poland

Medical University of Silesia Hospital

Katowice, Poland

University Hospital of Lord's Transfiguration

Poznan, Poland

Medical University of Warsaw

Warsaw, Poland

Institute of Cardiology

Warsaw, Poland

National Heart Center Singapore

Singapore, Singapore

Royal Victoria Hospital

Belfast, United Kingdom

Brighton and Sussex University Hospital

Brighton, United Kingdom

Royal Infirmary of Edinburgh

Edinburgh, United Kingdom

Leeds Teaching Hospitals NHS Trust

Leeds, United Kingdom

University Hospitals of Leicester NHS Trust

Leicester, United Kingdom

Guy's and St. Thomas' NHS Foundation Trust - St. Thomas Hospital

London, United Kingdom

Barts Heart Center

London, United Kingdom

John Radcliffe

Oxford, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT04029363


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