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REdo Transcatheter Aortic VALVE Implantation for the Management of Transcatheter Aortic Valve Failure
Sponsor: The Leeds Teaching Hospitals NHS Trust
Summary
Transcatheter aortic valve implantation (TAVI) is a key-hole technique to replace an aortic heart valve that is narrowed and/or leaking. Although TAVI is a safe and effective treatment for a faulty aortic heart valve, the new TAVI valve will not last forever. Because it is a 'tissue' valve (made from the lining of a cow or pig heart), the valve will fail after a period of time as the tissue degenerates. When the TAVI valve fails, a viable treatment option is to perform a 'Redo TAVI' procedure, implanting a second TAVI valve inside the first failing valve. The main purpose of this study is to carefully evaluate patients being treated by Redo TAVI in order to document the short-term and long-term outcomes of the procedure. The study will also obtain information about which factors predict those outcomes. The study will also assess outcomes in patients who present with TAVI valve failure but are not suitable for Redo TAVI, and instead are treated either by open-heart surgery and surgical aortic valve replacement, or by medical therapy (medication). The study will provide doctors the information they need to understand the best way to treat patients who present with TAVI valve failure, and in particular how to perform Redo TAVI procedures with the best possible outcomes for patients.
Official title: Prospective, Multi-centre Clinical Investigation Evaluating the Outcomes of Patients Treated by Redo Transcatheter Aortic Valve Implantation for Bioprosthetic Valve Failure of a Transcatheter Aortic Valve
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
550
Start Date
2024-12-12
Completion Date
2033-03
Last Updated
2026-04-06
Healthy Volunteers
No
Conditions
Interventions
Any commercially available Edwards or Medtronic transcatheter aortic valve with the TAV-in-TAV (Redo TAVI) indication
Redo TAVI will be performed using any commercially available Edwards or Medtronic transcatheter aortic valve platforms that have the TAV-in-TAV (Redo TAVI) indication according to the preferences of the local team in keeping with standard clinical care.
Surgical explantation and aortic valve replacement
Surgical explantation of all or part of the index transcatheter aortic valve, with open implantation of a new surgical or transcatheter aortic valve replacement will be performed according to the preferences of the local team in keeping with standard clinical care. Any commercially available approved surgical or transcatheter aortic valve may be used. Additional surgery, such as aortic root replacement, root enlargement, CABG, mitral valve repair/replacement, etc. will be performed at the discretion of the local team.
Conservative management
Conservative treatment, including optimal medical therapy +/- balloon aortic valvuloplasty
Locations (61)
Aalborg Universitethospital
Aalborg, Denmark
Århus Universitetshospital
Aarhus, Denmark
Rigshospitalet
Copenhagen, Denmark
HUS Helsinki University Hospital
Helsinki, Finland
Turku University Hospital
Turku, Finland
Clinical Saint Augustin - Elsan
Bordeaux, France
Brest University Hospital Centre
Brest, France
Henri Mondor University Hospital
Créteil, France
ICPS Hôpital privé Jacques-Cartier
Massy, France
Centre Hospitalier Universitaire de Montpellier
Montpellier, France
University Hospital of Nimes
Nîmes, France
Hospital Marie Lannelongue
Paris, France
Institute Mutualiste Montsouris
Paris, France
Les Hospital Universitaires de Strasbourg
Strasbourg, France
Clinique Pasteur Toulouse
Toulouse, France
CHRU Hospitals of Tours
Tours, France
Medipole Lyon-Villeurbanne
Villeurbanne, France
Kerckhoff Klinik
Bad Nauheim, Germany
Herz- und Diabeteszentrum NRW
Bad Oeynhausen, Germany
Klinikum Dortmund GmbH - St. Johannes Hospital
Dortmund, Germany
Herzzentrum Dresden Universitätsklinik
Dresden, Germany
Universitatsklinikum Dusseldorf (University Hospital Dusseldorf)
Düsseldorf, Germany
Universitatsklinikum Frankfurt
Frankfurt, Germany
Asklepios Klinik St. Georg
Hamburg, Germany
Universitätsklinikum Schleswig-Holstein (UKSH)
Kiel, Germany
HELIOS Herzzentrum Leipzig GmbH
Leipzig, Germany
Universitätsklinikum Schleswig-Holstein (UKSH)
Lübeck, Germany
LMU Klinikum
München, Germany
Universitatsklinikum Ulm (University Hospital Ulm)
Ulm, Germany
Shaare Zedek Medical Center
Jerusalem, Israel
Rabin Medical Center - Belinson Campus
Petah Tikva, Israel
Azienda Ospedaliero Universitaria Policlinico Vittorio Emanuele
Catania, Italy
Ospedale San Martino - IRCCS Ospedale Policlinico
Genova, Italy
Centro Cardiologico Monzino
Milan, Italy
IRCCS Ospedale San Raffaele
Milan, Italy
IRCSS Policlinico San Donato
San Donato Milanese, Italy
Ospedale Borgo Trento - Azienda Ospedaliera Universitaria Integrata Verona
Verona, Italy
Amphia Hospital
Breda, Netherlands
Maastricht University Medical Center (MUMC)
Maastricht, Netherlands
Erasmus University Medical Center
Rotterdam, Netherlands
Haukeland Sykehus
Bergen, Norway
Oslo University Hospital
Oslo, Norway
Sahlgrenska University Hospital
Gothenburg, Sweden
Skånes Universitetssjukhus Lund
Lund, Sweden
Nya Karolinska Sjukhuset Solna
Solna, Sweden
Inselspital - Universitätsspital Bern
Bern, Switzerland
Luzerner Kantonsspital
Lucerne, Switzerland
Queen Elizabeth Hospital
Birmingham, United Kingdom
Royal Sussex County Hospital
Brighton, United Kingdom
Bristol Royal Infirmary
Bristol, United Kingdom
University Hospital of Wales
Cardiff, United Kingdom
Golden Jubilee National Hospital
Glasgow, United Kingdom
Leeds Teaching Hospitals NHS Trust
Leeds, United Kingdom
Glenfield Hospital
Leicester, United Kingdom
Guys and St Thomas' NHS Foundation Trust
London, United Kingdom
St. George's Hospital
London, United Kingdom
Manchester Royal Infirmary
Manchester, United Kingdom
Freeman Hospital
Newcastle upon Tyne, United Kingdom
Oxford University Hospitals NHS Foundation Trust
Oxford, United Kingdom
University Hospital Southampton NHS Foundation Trust
Southampton, United Kingdom
New Cross Hospital
Wolverhampton, United Kingdom