Actively Recruiting
REdo Transcatheter Aortic VALVE Implantation for the Management of Transcatheter Aortic Valve Failure
Led by The Leeds Teaching Hospitals NHS Trust · Updated on 2026-05-13
550
Participants Needed
69
Research Sites
428 weeks
Total Duration
On this page
Sponsors
T
The Leeds Teaching Hospitals NHS Trust
Lead Sponsor
M
Medtronic
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
REdo Transcatheter Aortic VALVE Implantation for the Management of Transcatheter Aortic Valve Failure
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Bio-prosthetic Valve Failure of a Transcatheter Aortic Valve requiring possible reintervention
You will not qualify if you...
- Bio-prosthetic Valve Failure due solely to paravalvular aortic regurgitation
- Active endocarditis
- Untreated acute valve thrombosis
- Life-expectancy less than 1 year
- Subject is less than legal age of consent, legally incompetent, or otherwise vulnerable
- Pregnant or nursing
AI-Screening
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Trial Site Locations
Total: 69 locations
1
Aalborg Universitethospital
Aalborg, Denmark
Actively Recruiting
2
Århus Universitetshospital
Aarhus, Denmark
Actively Recruiting
3
Rigshospitalet
Copenhagen, Denmark
Actively Recruiting
4
HUS Helsinki University Hospital
Helsinki, Finland
Actively Recruiting
5
Turku University Hospital
Turku, Finland
Actively Recruiting
6
Clinical Saint Augustin - Elsan
Bordeaux, France
Actively Recruiting
7
Brest University Hospital Centre
Brest, France
Actively Recruiting
8
Henri Mondor University Hospital
Créteil, France
Actively Recruiting
9
ICPS Hôpital privé Jacques-Cartier
Massy, France
Actively Recruiting
10
Centre Hospitalier Universitaire de Montpellier
Montpellier, France
Actively Recruiting
11
University Hospital of Nimes
Nîmes, France
Actively Recruiting
12
Hospital Marie Lannelongue
Paris, France
Actively Recruiting
13
Institute Mutualiste Montsouris
Paris, France
Actively Recruiting
14
Les Hospital Universitaires de Strasbourg
Strasbourg, France
Actively Recruiting
15
Clinique Pasteur Toulouse
Toulouse, France
Actively Recruiting
16
CHRU Hospitals of Tours
Tours, France
Actively Recruiting
17
Medipole Lyon-Villeurbanne
Villeurbanne, France
Actively Recruiting
18
Kerckhoff Klinik
Bad Nauheim, Germany
Actively Recruiting
19
Herz- und Diabeteszentrum NRW
Bad Oeynhausen, Germany
Actively Recruiting
20
Deutsches Herzzentrum Berlin
Berlin, Germany
Withdrawn
21
Universitatsklinikum Koln (AoR)
Cologne, Germany
Actively Recruiting
22
Klinikum Dortmund GmbH - St. Johannes Hospital
Dortmund, Germany
Actively Recruiting
23
Herzzentrum Dresden Universitätsklinik
Dresden, Germany
Actively Recruiting
24
Universitatsklinikum Dusseldorf (University Hospital Dusseldorf)
Düsseldorf, Germany
Actively Recruiting
25
Universitatsklinikum Frankfurt
Frankfurt, Germany
Actively Recruiting
26
Asklepios Klinik St. Georg
Hamburg, Germany
Actively Recruiting
27
Universitätsklinikum Schleswig-Holstein (UKSH)
Kiel, Germany
Actively Recruiting
28
HELIOS Herzzentrum Leipzig GmbH
Leipzig, Germany
Actively Recruiting
29
Universitätsklinikum Schleswig-Holstein (UKSH)
Lübeck, Germany
Actively Recruiting
30
LMU Klinikum
München, Germany
Actively Recruiting
31
Universitatsklinikum Ulm (University Hospital Ulm)
Ulm, Germany
Actively Recruiting
32
Edith Wolfson Medical Center
Holon, Israel
Actively Recruiting
33
Shaare Zedek Medical Center
Jerusalem, Israel
Actively Recruiting
34
Rabin Medical Center - Belinson Campus
Petah Tikva, Israel
Actively Recruiting
35
ASST Spedali Civili Di Brescia
Brescia, Italy
Actively Recruiting
36
Fondazione Poliambulanza Istituto Ospedaliero
Brescia, Italy
Actively Recruiting
37
Azienda Ospedaliero Universitaria Policlinico Vittorio Emanuele
Catania, Italy
Actively Recruiting
38
Ospedale San Martino - IRCCS Ospedale Policlinico
Genova, Italy
Actively Recruiting
39
Centro Cardiologico Monzino
Milan, Italy
Actively Recruiting
40
Humanitas Research Hospital - RCCS Istituto Clinico Humanitas di Milano
Milan, Italy
Withdrawn
41
IRCCS Ospedale San Raffaele
Milan, Italy
Actively Recruiting
42
IRCSS Policlinico San Donato
San Donato Milanese, Italy
Actively Recruiting
43
Azienda Ospedaliera Ordine Mauriziano di Torino
Torino, Italy
Actively Recruiting
44
Ospedale Borgo Trento - Azienda Ospedaliera Universitaria Integrata Verona
Verona, Italy
Actively Recruiting
45
Amphia Hospital
Breda, Netherlands
Actively Recruiting
46
Maastricht University Medical Center (MUMC)
Maastricht, Netherlands
Actively Recruiting
47
Radboud Universitair Medisch Centrum
Nijmegen, Netherlands
Withdrawn
48
Erasmus University Medical Center
Rotterdam, Netherlands
Actively Recruiting
49
Haukeland Sykehus
Bergen, Norway
Actively Recruiting
50
Oslo University Hospital
Oslo, Norway
Actively Recruiting
51
Sahlgrenska University Hospital
Gothenburg, Sweden
Actively Recruiting
52
Skånes Universitetssjukhus Lund
Lund, Sweden
Actively Recruiting
53
Nya Karolinska Sjukhuset Solna
Solna, Sweden
Actively Recruiting
54
Inselspital - Universitätsspital Bern
Bern, Switzerland
Actively Recruiting
55
Luzerner Kantonsspital
Lucerne, Switzerland
Actively Recruiting
56
Queen Elizabeth Hospital
Birmingham, United Kingdom
Actively Recruiting
57
Royal Sussex County Hospital
Brighton, United Kingdom, BN2 1ES
Actively Recruiting
58
Bristol Royal Infirmary
Bristol, United Kingdom
Actively Recruiting
59
University Hospital of Wales
Cardiff, United Kingdom, CF14 4XW
Actively Recruiting
60
Golden Jubilee National Hospital
Glasgow, United Kingdom
Actively Recruiting
61
Leeds Teaching Hospitals NHS Trust
Leeds, United Kingdom, LS1 3EX
Actively Recruiting
62
Glenfield Hospital
Leicester, United Kingdom
Actively Recruiting
63
Guys and St Thomas' NHS Foundation Trust
London, United Kingdom
Actively Recruiting
64
St. George's Hospital
London, United Kingdom
Actively Recruiting
65
Manchester Royal Infirmary
Manchester, United Kingdom
Actively Recruiting
66
Freeman Hospital
Newcastle upon Tyne, United Kingdom
Actively Recruiting
67
Oxford University Hospitals NHS Foundation Trust
Oxford, United Kingdom, OX3 9DU
Actively Recruiting
68
University Hospital Southampton NHS Foundation Trust
Southampton, United Kingdom, SO16 6YD
Actively Recruiting
69
New Cross Hospital
Wolverhampton, United Kingdom
Actively Recruiting
Research Team
D
Dave Pickles
CONTACT
B
Benaka Karanth
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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