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NCT05601453Recruiting

The ReTAVI Prospective Observational Registry

Evaluation of Clinical Outcomes of Patients Undergoing a Redo-TAVI Procedure; a Multicenter Prospective Observational Registry

Source: ClinicalTrials.gov · Last updated 16 Oct 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Observational
Enrollment
250 (estimated)
First submitted
7 Oct 2022
Start date
5 Sept 2023
Primary completion date
Dec 2026
Lead sponsor
Institut für Pharmakologie und Präventive Medizin
NCT number
NCT05601453

What you commit to

  • Study type: Observational
  • Planned participants: 250
  • From 5 Sept 2023 to the primary completion date, Dec 2026
  • 62 sites in 11 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Pregnant women at the time of the redo-TAVI
    • Note: For all patients included a defined core data set will be collected prospectively. All patients being in accordance with above stated inclusion and exclusion criteria and receiving a balloon-expandable transcatheter aortic valve will be included in the extended documentation.

Other

  • Patients without signed informed consent / data protection statement (according to requirements of local IRB/IEC)
  • Life expectancy below 12 months
  • Patients with largely incomplete data with respect to the aims of the project

Who the study is looking for

  • Consecutive patients fulfilling the following criteria:
  • Consenting adult patient (≥18 years)
  • Procedural success of the first TAVI
  • TAVI device failure of the index THV, irrespective of SVD severity
  • Intention to treat the patient with a redo-TAVI procedure (SAPIEN family THV)
  • The Local Heart Team and the Case Review Board consider the patient suitable and indicated for elective redo-TAVI
  • Patient is scheduled to undergo a 30 Day and 12 Months follow-up (both visits taking place in the hospital)

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (62)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
LKH-University Hospital and Medical University of Graz
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GrazAustriaRecruiting
Kepler University Clinic Linz
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LinzAustriaRecruiting
University Hospital St. Pölten
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Sankt PöltenAustriaRecruiting
Medical University of Vienna
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ViennaAustriaRecruiting
McGill University Health Centre
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MontrealCanadaRecruiting
Institut Universitaire de Cardiologie et de Pneumologie
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QuébecCanadaRecruiting
St. Paul's Hospital, Vancouver
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VancouverCanadaRecruiting
University Hospital of Basel
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BaselSwitzerlandRecruiting
Hôpitaux universitaires de Genève
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GenevaSwitzerlandRecruiting
Centre hospitalier universitaire vaudois et Université de Lausanne
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LausanneSwitzerlandRecruiting
University Heart Center Freiburg - Bad Krozingen
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Bad KrozingenGermanyRecruiting
Kerckhoff-Klinik GmbH, UKGM GmbH
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Bad NauheimGermanyRecruiting
Heart and Diabetes Center North Rhine-Westphalia
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Bad OeynhausenGermanyRecruiting
German Heart Center of Charité Berlin
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BerlinGermanyRecruiting
BG University Hospital Bergmannsheil gGmbH
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BochumGermanyRecruiting
University Hospital of Duesseldorf
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DüsseldorfGermanyRecruiting
Elisabeth Hospital, Essen
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EssenGermanyRecruiting
German Heart Centre Munich
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MunichGermanyRecruiting
Robert-Bosch-Hospital, Stuttgart
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StuttgartGermanyRecruiting
University Hospital Ulm
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UlmGermanyRecruiting
Hospital Clinic de Barcelona
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BarcelonaSpainRecruiting
Hospital University Germans Trias i Pujol
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BarcelonaSpainRecruiting
Hospital de la Santa Creu i Sant Pau
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BarcelonaSpainRecruiting
Hospital Universitario De Leon
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LeónSpainRecruiting
Hospital Clínico Universitario San Carlos
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MadridSpainRecruiting
Hospital Universitario Central De Asturias
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OviedoSpainRecruiting
Hospital Álvaro Cunqueiro (Vigo)
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VigoSpainRecruiting
Centre hospitalier Universitaire de Bordeaux
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BordeauxFranceRecruiting
Centre Hospitalier Universitaire de Clermont-Ferrand
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Clermont-FerrandFranceRecruiting
Centre Hospitalier Universitaire de Lille
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LilleFranceRecruiting
Hospices Civils de Lyon
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LyonFranceRecruiting
Hôpitaux Universitaires de Marseille Timone
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MarseilleFranceRecruiting
Jacques Cartier Private Hospital, Massy
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MassyFranceRecruiting
Centre Hospitalier Universitaire de Nantes
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NantesFranceRecruiting
Hôpital Européen Georges Pompidou
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ParisFranceRecruiting
Hôpital Bichat - Claude-Bernard
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ParisFranceRecruiting
Centre Hospitalier Universitaire de Rennes
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RennesFranceRecruiting
Centre Hospitalier Universitaire de Rouen
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RoubaixFranceRecruiting
Clinique de la Porte de Paris (CCN)
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Saint-DenisFranceRecruiting
Centre Hospitalier Universitaire de Toulouse
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ToulouseFranceRecruiting
Tel Aviv Medical Center
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Tel AvivIsraelRecruiting
AOU Ospedali Riuniti Ancona, Umberto I, G. M. Lancisi, G. Salesi
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AnconaItalyWithdrawn
IRCCS Azienda Ospedaliero-Universitaria di Bologna
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BolognaItalyRecruiting
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
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BresciaItalyRecruiting
Careggi Hospital
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FlorenceItalyRecruiting
IRCCS Ospedale Galeazzi Sant'Ambrogio
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MilanItalyRecruiting
Azienda Ospedale-Università Padova (AOUP)
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PaduaItalyRecruiting
Azienda Ospedaliero Universitaria Pisana
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PisaItalyRecruiting
Policlinici universitari | Sapienza Università di Roma
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RomaItalyRecruiting
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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RomaItalyRecruiting
Università degli Studi di Trieste
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TriesteItalyRecruiting
Ospedale San Bortolo di Vicenza
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VicenzaItalyRecruiting
St. Antonius Ziekenhuis Nieuwegein
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NieuwegeinNetherlandsRecruiting
Medical University of Bialystok
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BialystokPolandRecruiting
University Clinical Centre of Gdańsk
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GdanskPolandWithdrawn
Medical University of Silesia
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KatowicePolandWithdrawn
University Hospital of Kraków
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KrakowPolandRecruiting
Institute of Cardiology, Warsaw
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WarsawPolandRecruiting
Medical University of Warsaw
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WarsawPolandRecruiting
Wroclaw Medical University
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WroclawPolandRecruiting
Hospital de Santa Cruz, Carnaxide-Lisabon
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CarnaxidePortugalRecruiting
Centro Hospitalar Vila Nova de Gaia/Espinho
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Vila Nova de GaiaPortugalRecruiting

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This page is information, not medical advice. Discuss any trial with your doctor.