Actively Recruiting
The ReTAVI Prospective Observational Registry
Led by Institut für Pharmakologie und Präventive Medizin · Updated on 2025-08-20
250
Participants Needed
62
Research Sites
429 weeks
Total Duration
On this page
Sponsors
I
Institut für Pharmakologie und Präventive Medizin
Lead Sponsor
E
Edwards Lifesciences
Collaborating Sponsor
AI-Summary
What this Trial Is About
Patients with severe aortic stenosis (sAS) treated with transcatheter aortic valve implantation (TAVI) (increasingly younger \& lower risk pts) are experiencing SVD of the index THV and thus developing an indication for a redo-TAVI procedure. The evidence on redo-TAVI (where a transcatheter heart valve \[THV\] is implanted into another THV) is limited, with initial data showing acceptable safety as well efficacy in highly selected and limited populations. Aim is to evaluate short- and long-term data on patients undergoing transcatheter redo-TAVI procedures with THVs for failure of a previously implanted THV and to determine VARC-3 defined efficacy and safety at 30 days and functional outcome at 1 year, 3 years and 5 years.
CONDITIONS
Official Title
The ReTAVI Prospective Observational Registry
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult patient aged 18 years or older
- Successful first TAVI procedure
- Failure of the initial transcatheter heart valve (THV), regardless of severity
- Planned treatment with a redo-TAVI procedure using a SAPIEN family valve
- Considered suitable and indicated for elective redo-TAVI by the Local Heart Team and Case Review Board
- Scheduled for follow-up visits at 30 days and 12 months after redo-TAVI at the hospital
You will not qualify if you...
- No signed informed consent or data protection statement
- Life expectancy less than 12 months
- Incomplete data relevant to study aims
- Pregnant at the time of redo-TAVI procedure
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 62 locations
1
LKH-University Hospital and Medical University of Graz
Graz, Austria, 8010
Actively Recruiting
2
Kepler University Clinic Linz
Linz, Austria, 4020
Actively Recruiting
3
University Hospital St. Pölten
Sankt Pölten, Austria, 3100
Actively Recruiting
4
Medical University of Vienna
Vienna, Austria, 1090
Actively Recruiting
5
McGill University Health Centre
Montreal, Canada, H4A 3J1
Actively Recruiting
6
Institut Universitaire de Cardiologie et de Pneumologie
Québec, Canada, QC G1V 4G5
Actively Recruiting
7
St. Paul's Hospital, Vancouver
Vancouver, Canada, BC V6Z 1Y6
Actively Recruiting
8
Centre Hospitalier Universitaire de Bordeaux
Bordeaux, France, 33604
Actively Recruiting
9
Centre Hospitalier Universitaire de Clermont-Ferrand
Clermont-Ferrand, France, 63003
Actively Recruiting
10
Centre Hospitalier Universitaire de Lille
Lille, France, 59037
Actively Recruiting
11
Hospices Civils de Lyon
Lyon, France, 69677
Actively Recruiting
12
Hôpitaux Universitaires de Marseille Timone
Marseille, France, 13005
Actively Recruiting
13
Jacques Cartier Private Hospital, Massy
Massy, France, 91300
Actively Recruiting
14
Centre Hospitalier Universitaire de Nantes
Nantes, France, 44093
Actively Recruiting
15
Hôpital Européen Georges-Pompidou
Paris, France, 75015
Actively Recruiting
16
Hôpital Bichat-Claude-Bernard
Paris, France, 75018
Actively Recruiting
17
Centre hospitalier universitaire de Rennes
Rennes, France, 35033
Actively Recruiting
18
Centre Hospitalier Universitaire de Rouen
Roubaix, France, 76000
Actively Recruiting
19
Clinique de la Porte de Paris (CCN)
Saint-Denis, France, 93200
Actively Recruiting
20
Centre Hospitalier Universitaire de Toulouse
Toulouse, France, 31059
Actively Recruiting
21
University Heart Center Freiburg Bad Krozingen
Bad Krozingen, Germany, 79189
Actively Recruiting
22
Kerckhoff-Klinik GmbH, UKGM GmbH
Bad Nauheim, Germany, 61231
Actively Recruiting
23
Heart and Diabetes Center North Rhine-Westphalia
Bad Oeynhausen, Germany, 32545
Actively Recruiting
24
German Heart Center of Charité Berlin
Berlin, Germany, 13353
Actively Recruiting
25
BG University Hospital Bergmannsheil gGmbH
Bochum, Germany, 44789
Actively Recruiting
26
University Hospital of Duesseldorf
Düsseldorf, Germany, 40225
Actively Recruiting
27
Elisabeth Hospital, Essen
Essen, Germany, 45138
Actively Recruiting
28
German Heart Centre Munich
Munich, Germany, 80636
Actively Recruiting
29
Robert-Bosch-Hospital, Stuttgart
Stuttgart, Germany, 70376
Actively Recruiting
30
University Hospital Ulm
Ulm, Germany, 89070
Actively Recruiting
31
Tel Aviv Medical Center
Tel Aviv, Israel, 6423906
Actively Recruiting
32
AOU Ospedali Riuniti Ancona, Umberto I, G. M. Lancisi, G. Salesi
Ancona, Italy, 60126
Withdrawn
33
IRCCS Azienda Ospedaliero Universitaria di Bologna
Bologna, Italy, 40138
Actively Recruiting
34
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
Brescia, Italy, 25123
Actively Recruiting
35
Careggi Hospital
Florence, Italy, 50134
Actively Recruiting
36
IRCCS Ospedale Galeazzi Sant'Ambrogio
Milan, Italy, 20157
Actively Recruiting
37
Azienda Ospedale-Università Padova (AOUP)
Padua, Italy, 35128
Actively Recruiting
38
Azienda Ospedaliero-Universitaria Pisana
Pisa, Italy, 56124
Actively Recruiting
39
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma, Italy, 00168
Actively Recruiting
40
Policlinici universitari | Sapienza Università di Roma
Roma, Italy, 00185
Actively Recruiting
41
Università degli Studi di Trieste
Trieste, Italy, 34149
Actively Recruiting
42
Ospedale San Bortolo di Vicenza
Vicenza, Italy, 36100
Actively Recruiting
43
St. Antonius Ziekenhuis, Nieuwegein
Nieuwegein, Netherlands, 3435
Actively Recruiting
44
Medical University of Bialystok
Bialystok, Poland, 15-089
Actively Recruiting
45
University Clinical Centre of Gdańsk
Gdansk, Poland, 80-952
Withdrawn
46
Medical University of Silesia
Katowice, Poland, 40-055
Withdrawn
47
University Hospital of Kraków
Krakow, Poland, 31-501
Actively Recruiting
48
Medical University of Warsaw
Warsaw, Poland, 02-091
Actively Recruiting
49
Institute of Cardiology Warsaw
Warsaw, Poland, 04-628
Actively Recruiting
50
Wroclaw Medical University
Wroclaw, Poland, 50-368
Actively Recruiting
51
Hospital de Santa Cruz, Carnaxide-Lisabon
Carnaxide, Portugal, 2790-134
Actively Recruiting
52
Centro Hospitalar Vila Nova de Gaia / Espinho
Vila Nova de Gaia, Portugal, 4434-502
Actively Recruiting
53
Hospital de la Santa Creu i Sant Pau
Barcelona, Spain, 08025
Actively Recruiting
54
Hospital Clinic de Barcelona
Barcelona, Spain, 08036
Actively Recruiting
55
Hospital University Germans Trias i Pujol
Barcelona, Spain, 08916
Actively Recruiting
56
Hospital Universitario de León
León, Spain, 24008
Actively Recruiting
57
Hospital Clinico Universitario San Carlos
Madrid, Spain, 28040
Actively Recruiting
58
Hospital Universitario Central de Asturias
Oviedo, Spain, 33011
Actively Recruiting
59
Hospital Álvaro Cunqueiro, Vigo
Vigo, Spain, 36312
Actively Recruiting
60
University Hospital of Basel
Basel, Switzerland, 4031
Actively Recruiting
61
Hôpitaux universitaires de Genève
Geneva, Switzerland, 1205
Actively Recruiting
62
Centre hospitalier universitaire vaudois et Université de Lausanne
Lausanne, Switzerland, 1011
Actively Recruiting
Research Team
C
Claudia Lüske, PhD
CONTACT
D
Daniel Greinert
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
1
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