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.

Centers
Selection completed
Patients
Recruiting

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

  • Giuseppe Tarantini
    Giuseppe Tarantini

    Department of Cardiac, Thoracic, Vascular Sciences and Public Health,

    University of Padua Medical School, Padua, Italy

  • Radoslaw Parma
    Radoslaw Parma

    Department of Cardiology and Structural Heart Diseases, GCM,

    Medical University of Silesia, Katowice, Poland

Steering Committee Members

  • Thomas Cuisset
    Thomas Cuisset
  • Victoria Delgado
    Victoria Delgado
  • Michael Joner
    Michael Joner
  • Thomas Modine
    Thomas Modine
  • Francesco Saia
    Francesco Saia
  • Josep Rodés-Cabau
    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

München

1 center

St. Pölten

1 center

Bad Krozingen

1 center

Rennes

1 center

Wien

1 center

Basel

1 center

Nantes

1 center

Graz

1 center

Lausanne

1 center

Genève

1 center

Clermont-Ferrand

1 center

Lyon

1 center

Trieste

1 center

Brescia

1 center

Milano

1 center

Vicenza

1 center

Padova

1 center

Boradeaux

1 center

Bologna

1 center

Firenze

1 center

Pisa

1 center

Toulouse

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

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

  •  To prospectively evaluate safety & efficacy of TAVI-in-TAVI due to SVD

  • To identify key procedural factors associated with optimal results
    -
    Implant depth, commissure alignment, coronary position, sizing, VTC, VTA

  • To assess the durability of the second aortic THV

  • To identify predictors of (early) suboptimal acute results and late BVF

  • To validate VARC 3 applicability in THV in THV setting

  • 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:

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

Exclusion Criteria:

  1. Patients without signed informed consent/data protection statement (according to requirements of local IRB/IEC)
  2. Life expectancy below 12 months
  3. Patients with largely incomplete data with respect to the aims of the project
  4. 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.

News

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