ReTAVI Registry
Evaluation of Clinical Outcomes of Patients Undergoing a redo-TAVI procedure
A Multicenter Prospective Observational Registry
Trial was registered at Clinicaltrials.gov under NCT05601453.
ReTAVI Registry
The purpose of this trial is to collect and evaluate the clinical outcomes of patients undergoing a redo-TAVI procedure in multiple European and Canadian centres
- First prospective, multicenter study with redo-TAVI patients
- Registry to evaluate Efficacy, Technical success & Safety of using THV-in-THV with Sapien 3 or Sapien 3 Ultra
- The study investigates the redo-TAVI procedure with the only CE-marked product for this purpose
Principal Investigators
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Giuseppe TarantiniDepartment of Cardiac, Thoracic, Vascular Sciences and Public Health,
University of Padua Medical School, Padua, Italy
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Radoslaw ParmaDepartment of Cardiology and Structural Heart Diseases, GCM,
Medical University of Silesia, Katowice, Poland
Steering Committee Members
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Thomas Cuisset -
Victoria Delgado -
Michael Joner -
Thomas Modine -
Francesco Saia -
Josep Rodés-Cabau
Refer my patients
Please see the centers connected to the trial for referring your patients with structural valve deterioration of first TAVI to smooth treatment in our specialized network of sites. To see the nearest center, please click on your country to explore given sites.
Centers
Gdansk
1 center
Bialystok
1 center
Berlin
1 center
Warszawa
2 centers
Bad Oyenhausen
1 center
Cambridge
1 center
Nieuwegein
1 center
Bochum
1 center
Essen
1 center
London
1 center
Dusseldorf
1 center
Wroclaw
1 center
Giessen
1 center
Katowice
1 center
Kraków
1 center
Lille
1 center
Rouen
1 center
Paris
4 centers
Stuttgart
1 center
Ulm
1 center
Linz
1 center
St. Pölten
1 center
Bad Krozingen
1 center
Rennes
1 center
Wien
1 center
München
1 center
Basel
1 center
Nantes
1 center
Graz
1 center
Lausanne
1 center
Genève
1 center
Clermont-Ferrand
1 center
Lyon
1 center
Vicenza
1 center
Trieste
1 center
Milano
1 center
Brescia
1 center
Padova
1 center
Boradeaux
1 center
Bologna
1 center
Firenze
1 center
Toulouse
1 center
Pisa
1 center
Ancona
1 center
Oviedo
1 center
Marseille
1 center
León
1 center
Vigo
1 center
Rome
2 centers
Barcelona
3 centers
Porto
1 center
Madrid
1 center
Lisabon
1 center
Vancouver
1 center
Québec
1 center
Montreal
1 center
Tel Aviv
1 center
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Elisabeth-Krankenhaus Essen
Essen, GermanyPrincipal investigator
Dr Alexander Wolf -
Górnośląskie Centrum Medyczne
Katowice, PolandPrincipal investigator
Dr Radoslaw Parma -
Harefield Hospital, London
London, UKPrincipal investigator
Dr Vasileios Panoulas -
Herz- und Diabeteszentrum NRW, Bad Oeynhausen
Bad Oyenhausen, GermanyPrincipal investigator
Prof. Sabine Bleiziffer -
Hôpital Bichat - Claude-Bernard AP-HP
Paris, FrancePrincipal investigator
Prof. Marina Urena Alcazar -
Hôpital Européen Georges-Pompidou AP-HP
Paris, FrancePrincipal investigator
Prof. Nicole Karam
Learn more about trial
Design
An investigator-initiated, non-interventional (observational), multicenter, international prospective registry in patients undergoing redo TAVI.
Objectives
Increasingly younger & lower-risk AS patients treated with TAVI live long enough to experience SVD and develop indications for TAVI-in-TAVI procedure
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To prospectively evaluate safety & efficacy of TAVI-in-TAVI due to SVD
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To identify key procedural factors associated with optimal results
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Implant depth, commissure alignment, coronary position, sizing, VTC, VTA -
To assess the durability of the second aortic THV
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To identify predictors of (early) suboptimal acute results and late BVF
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To validate VARC 3 applicability in THV in THV setting
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To validate and assess adherence to the procedural strategy recommended in the published expert consensus
Primary Endpoints
- Efficacy: VARC-3 defined device success at 30 days
- Technical success: Technical success (at exit from procedure room)
- Safety: VARC-3 defined early safety at 30 days
- Procedural Outcomes (30 days)
- Durability of the second aortic THV (30 days, 3 and 12 months)
Population
- sAS Patients who underwent TAVI and are experiencing index THV SVD indication for a redo TAVI procedure
- Local heart team and Case Review Board considers the patient suitable and indicated for elective TAVI-in-TAVI
Inclusion Criteria:
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)
Exclusion Criteria:
- 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
- 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 the above-stated inclusion and exclusion criteria and receiving a balloon-expandable transcatheter aortic valve will be included in the extended documentation.
Collaboration
ReTAVI is an investigator initiated, observational study funded by a research grant from Edwards Lifesciences
IPPMed GmbH is acting as the Sponsor and coordinating clinical research organization