REdo Transcatheter Aortic VALVE Implantation for the Management of Transcatheter Aortic Valve Failure

RecruitingOBSERVATIONAL
Enrollment

550

Participants

Timeline

Start Date

December 12, 2024

Primary Completion Date

June 30, 2027

Study Completion Date

March 31, 2033

Conditions
Aortic Valve Stenosis
Interventions
DEVICE

Any commercially available transcatheter aortic valve

Redo TAVI will be performed using any commercially available transcatheter aortic valve according to the preferences of the local team in keeping with standard clinical care.

PROCEDURE

Surgical explantation and aortic valve replacement

Surgical explantation and 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 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.

OTHER

Conservative management

Conservative treatment, including optimal medical therapy +/- balloon aortic valvuloplasty

Trial Locations (21)

Unknown

RECRUITING

Århus Universitetshospital, Aarhus

RECRUITING

Rigshospitalet, Copenhagen

RECRUITING

HUS Helsinki University Hospital, Helsinki

RECRUITING

Turku University Hospital, Turku

RECRUITING

Maastricht University Medical Center (MUMC), Maastricht

RECRUITING

Erasmus University Medical Center, Rotterdam

RECRUITING

Haukeland Sykehus, Bergen

RECRUITING

Oslo University Hospital, Oslo

RECRUITING

Sahlgrenska University Hospital, Gothenburg

RECRUITING

Inselspital - Universitätsspital Bern, Bern

RECRUITING

Luzerner Kantonsspital, Lucerne

RECRUITING

Bristol Royal Infirmary, Bristol

RECRUITING

Golden Jubilee National Hospital, Glasgow

RECRUITING

St. George's Hospital, London

RECRUITING

Freeman Hospital, Newcastle upon Tyne

RECRUITING

New Cross Hospital, Wolverhampton

BN2 1ES

RECRUITING

Royal Sussex County Hospital, Brighton

CF14 4XW

RECRUITING

University Hospital of Wales, Cardiff

LS1 3EX

RECRUITING

Leeds Teaching Hospitals NHS Trust, Leeds

OX3 9DU

RECRUITING

Oxford University Hospitals NHS Foundation Trust, Oxford

SO16 6YD

RECRUITING

University Hospital Southampton NHS Foundation Trust, Southampton

Sponsors

Collaborators (2)

All Listed Sponsors
collaborator

Medtronic

INDUSTRY

collaborator

NAMSA

OTHER

lead

The Leeds Teaching Hospitals NHS Trust

OTHER