The ReTAVI Prospective Observational Registry

Last updated: February 17, 2025
Sponsor: Institut für Pharmakologie und Präventive Medizin
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Elective redo transcatheter aortic valve implantation (redo-TAVI)

Clinical Study ID

NCT05601453
ReTAVI Registry
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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 andindicated for elective redo-TAVI

  6. Patient is scheduled to undergo a 30 Day and 12 Months follow-up (both visits takingplace in the hospital)

Exclusion

Exclusion Criteria:

  1. Patients without signed informed consent / data protection statement (according torequirements 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 above stated inclusion and exclusion criteria and receiving a balloon-expandable transcatheter aortic valve will be included in the extended documentation.

Study Design

Total Participants: 150
Treatment Group(s): 1
Primary Treatment: Elective redo transcatheter aortic valve implantation (redo-TAVI)
Phase:
Study Start date:
September 05, 2023
Estimated Completion Date:
December 31, 2026

Study Description

Between 1.4 and 2.8% of all patients undergoing transcatheter heart valve (THV) implantation require a second THV implanted into the previously implanted THV because of clinically significant aortic regurgitation [1-3]. 90% of THV-in-THV implants were considered successful although the mortality in the redo-TAVI group was higher at similar STS risks as in those with a successful first implant.

Redo-TAVI may also be a promising treatment strategy in degenerated THVs, but there is insufficient knowledge which strategy and valve design may result in the best outcomes [4]. Evidence so far reported is based on case reports and small case series, but not on a prospective, multicenter documentation.

Currently, ~ 5% of THV are implanted in degenerated surgical bioprosthetic valves. With the expanded use of THV for treatment of lower risk patients with severe aortic stenosis (sAS), it is estimated that the number of patients requiring re-treatment for THV failure is likely to rise within the next years.

Connect with a study center

  • LKH-University Hospital and Medical University of Graz

    Graz, 8010
    Austria

    Active - Recruiting

  • Kepler University Clinic Linz

    Linz, 4020
    Austria

    Active - Recruiting

  • University Hospital St. Pölten

    St. Pölten, 3100
    Austria

    Active - Recruiting

  • Medical University of Vienna

    Vienna, 1090
    Austria

    Active - Recruiting

  • Trillium Health Partners Mississauga Hospital

    Mississauga, ON L5B 1B8
    Canada

    Site Not Available

  • McGill University Health Centre

    Montréal, H4A 3J1
    Canada

    Active - Recruiting

  • Institut Universitaire de Cardiologie et de Pneumologie

    Québec, QC G1V 4G5
    Canada

    Active - Recruiting

  • Toronto General Hospital

    Toronto, ON M5G 2C4
    Canada

    Site Not Available

  • St. Paul's Hospital, Vancouver

    Vancouver, BC V6Z 1Y6
    Canada

    Active - Recruiting

  • Centre Hospitalier Universitaire de Bordeaux

    Bordeaux, 33604
    France

    Active - Recruiting

  • Centre Hospitalier Universitaire de Clermont-Ferrand

    Clermont-Ferrand, 63003
    France

    Active - Recruiting

  • Centre Hospitalier Universitaire de Lille

    Lille, 59037
    France

    Active - Recruiting

  • Hospices Civils de Lyon

    Lyon, 69677
    France

    Active - Recruiting

  • Hôpitaux Universitaires de Marseille Timone

    Marseille, 13005
    France

    Active - Recruiting

  • Jacques Cartier Private Hospital, Massy

    Massy, 91300
    France

    Active - Recruiting

  • Centre Hospitalier Universitaire de Nantes

    Nantes, 44093
    France

    Active - Recruiting

  • Hôpital Bichat-Claude-Bernard

    Paris, 75018
    France

    Active - Recruiting

  • Hôpital Européen Georges-Pompidou

    Paris, 75015
    France

    Active - Recruiting

  • Centre hospitalier universitaire de Rennes

    Rennes, 35033
    France

    Active - Recruiting

  • Centre Hospitalier Universitaire de Rouen

    Roubaix, 76000
    France

    Active - Recruiting

  • Clinique de la Porte de Paris (CCN)

    Saint-Denis, 93200
    France

    Active - Recruiting

  • Centre Hospitalier Universitaire de Toulouse

    Toulouse, 31059
    France

    Active - Recruiting

  • Central Hospital Bad Berka

    Bad Berka, 99438
    Germany

    Site Not Available

  • University Heart Center Freiburg Bad Krozingen

    Bad Krozingen, 79189
    Germany

    Active - Recruiting

  • Kerckhoff-Klinik GmbH, UKGM GmbH

    Bad Nauheim, 61231
    Germany

    Active - Recruiting

  • Heart and Diabetes Center North Rhine-Westphalia

    Bad Oeynhausen, 32545
    Germany

    Active - Recruiting

  • German Heart Center of Charité Berlin

    Berlin, 13353
    Germany

    Active - Recruiting

  • BG University Hospital Bergmannsheil gGmbH

    Bochum, 44789
    Germany

    Active - Recruiting

  • University Hospital of Duesseldorf

    Duesseldorf, 40225
    Germany

    Active - Recruiting

  • Elisabeth Hospital, Essen

    Essen, 45138
    Germany

    Active - Recruiting

  • University Hospital Hamburg

    Hamburg, 20251
    Germany

    Site Not Available

  • MHH Hannover Medical School

    Hannover, 30625
    Germany

    Site Not Available

  • German Heart Centre Munich

    Munich, 80636
    Germany

    Active - Recruiting

  • Robert-Bosch-Hospital, Stuttgart

    Stuttgart, 70376
    Germany

    Active - Recruiting

  • University Hospital Ulm

    Ulm, 89070
    Germany

    Active - Recruiting

  • Tel Aviv Medical Center

    Tel Aviv, 6423906
    Israel

    Active - Recruiting

  • AOU Ospedali Riuniti Ancona, Umberto I, G. M. Lancisi, G. Salesi

    Ancona, 60126
    Italy

    Site Not Available

  • IRCCS Azienda Ospedaliero Universitaria di Bologna

    Bologna, 40138
    Italy

    Active - Recruiting

  • Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

    Brescia, 25123
    Italy

    Active - Recruiting

  • Careggi Hospital

    Florence, 50134
    Italy

    Active - Recruiting

  • IRCCS Ospedale Galeazzi Sant'Ambrogio

    Milan, 20157
    Italy

    Active - Recruiting

  • Azienda Ospedale-Università Padova (AOUP)

    Padua, 35128
    Italy

    Active - Recruiting

  • Azienda Ospedaliero-Universitaria Pisana

    Pisa, 56124
    Italy

    Active - Recruiting

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    Roma, 00168
    Italy

    Active - Recruiting

  • Policlinici universitari | Sapienza Università di Roma

    Roma, 00185
    Italy

    Active - Recruiting

  • Università degli Studi di Trieste

    Trieste, 34149
    Italy

    Active - Recruiting

  • Ospedale San Bortolo di Vicenza

    Vicenza, 36100
    Italy

    Active - Recruiting

  • St. Antonius Ziekenhuis, Nieuwegein

    Nieuwegein, 3435
    Netherlands

    Active - Recruiting

  • Medical University of Bialystok

    Bialystok, 15-089
    Poland

    Active - Recruiting

  • University Clinical Centre of Gdańsk

    Gdańsk, 80-952
    Poland

    Site Not Available

  • Medical University of Silesia

    Katowice, 40-055
    Poland

    Site Not Available

  • University Hospital of Kraków

    Kraków, 31-501
    Poland

    Active - Recruiting

  • Institute of Cardiology Warsaw

    Warsaw, 04-628
    Poland

    Active - Recruiting

  • Medical University of Warsaw

    Warsaw, 02-091
    Poland

    Active - Recruiting

  • Wroclaw Medical University

    Wrocław, 50-368
    Poland

    Active - Recruiting

  • Hospital de Santa Cruz, Carnaxide-Lisabon

    Carnaxide, 2790-134
    Portugal

    Active - Recruiting

  • Centro Hospitalar Vila Nova de Gaia / Espinho

    Vila Nova De Gaia, 4434-502
    Portugal

    Active - Recruiting

  • Karte von Centro Hospitalar Vila Nova de Gaia / Espinho - Unit 1 Von außen ansehen Centro Hospitalar Vila Nova de Gaia / Espinho

    Vila Nova De Gaia, 4434-502
    Portugal

    Site Not Available

  • Hospital Clinic de Barcelona

    Barcelona, 08036
    Spain

    Active - Recruiting

  • Hospital University Germans Trias i Pujol

    Barcelona, 08916
    Spain

    Active - Recruiting

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, 08025
    Spain

    Active - Recruiting

  • Hospital Universitario de León

    León, 24008
    Spain

    Active - Recruiting

  • Hospital Clinico Universitario San Carlos

    Madrid, 28040
    Spain

    Active - Recruiting

  • Hospital Universitario Central de Asturias

    Oviedo, 33011
    Spain

    Active - Recruiting

  • University Hospital of Salamanca

    Salamanca, 37007
    Spain

    Site Not Available

  • Hospital Clínico Universitario de Santiago

    Santiago de Compostela, 15706
    Spain

    Site Not Available

  • Hospital Álvaro Cunqueiro, Vigo

    Vigo, 36312
    Spain

    Active - Recruiting

  • University Hospital of Basel

    Basel, 4031
    Switzerland

    Active - Recruiting

  • Hôpitaux universitaires de Genève

    Geneva, 1205
    Switzerland

    Active - Recruiting

  • Centre hospitalier universitaire vaudois et Université de Lausanne

    Lausanne, 1011
    Switzerland

    Active - Recruiting

  • Royal Papworth Hospital, Cambridge

    Cambridge, CB2 0AY
    United Kingdom

    Site Not Available

  • Harefield Hospital

    Harefield, UB9 6JH
    United Kingdom

    Site Not Available

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