The ReTAVI Prospective Observational Registry

NCT05601453 | Recruiting

• 1 other identifier: ReTAVI Registry
• Study Type: observational
• Target: 250
• Locations: 11 countries
• Sites: 62

Brief 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, 3 years and 5 years.

Conditions

Structural Valve Deterioration; Structural Valve Degeneration; Symptomatic Patients Who Have Had Transcatheter Heart Valve (THV) Failure; Prosthetic Valve Malfunction; Prosthesis Failure

Keywords

Transcatheter Aortic Valve Implantation (TAVI); Structural Valve Deterioration; redo-TAVI; THV-in-THV; TAV-in-TAV; TAVR-in-TAVR; Redo-TAVR; Revalve

Outcome Measures

Primary Outcomes (9)

• Efficacy: VARC-3 defined device success at 30 days

  Determine VARC-3 defined device success at 30 days * Technical success * Freedom from mortality * Freedom from surgery or intervention related to the device or a major vascular or access-related or cardiac structural complication * Intended performance of the valve (mean gradient \<20 mmHg, peak velocity \<3 m/s, Doppler velocity index ≥0.25, and less than moderate aortic regurgitation) (Different definitions, in addition to the predefined such as the consideration of higher gradients than 20 mmHg, will be explored) These events will be adjudicated. Number and percentage of subjects with device success at 30 days as per VARC-3 definition, along with individual component of the success, will be presented.

  30 days

• Technical success: Technical success (at exit from procedure room)

  Technical success at exit from procedure room defined as: * Freedom from mortality * Successful access, delivery of the device, and retrieval of the delivery system * Correct positioning of a single prosthetic heart valve into the proper anatomical location * Freedom from surgery or intervention related to the device (excluding pacemaker) or to a major vascular or access-related, or cardiac structural complication Number and percentage of subjects with technical success at exit from procedure room, along with individual component of the success, will be presented.

  end of intervention

• Safety: VARC-3 defined early safety at 30 days

  Determine VARC-3 defined early safety at 30 days: * Freedom from all-cause mortality * Freedom from all Stroke * Freedom from all VARC type 2-4 bleeding * Freedom from all major vascular, access-related, or cardiac structural complication * Freedom from all acute kidney injury stage III/IV * Freedom from all moderate/severe aortic regurgitation * Freedom from all new permanent pacemaker implantations due to procedure-related conduction abnormalities * Freedom from all surgery/intervention related to the device These events will be adjudicated. Number and percentage of subjects with early safety at 30 days as per VARC-3 definition, along with individual component of the success, will be presented.

  30 days

• Procedural Outcomes (30 days)

  Procedural outcomes at 30 days, defined as: * Clinical and anatomical predictors of technical success (type of SVD \[stenosis vs. regurgitation\], valve size, implant depth, redo-TAVI balloon dilation, CT and echo-derived variables, etc.) * Rate of central and paravalvular regurgitation * Valve performance, including residual mean gradient * Risk and predictors of coronary obstruction Number and percentage of subjects with above specified outcomes at 30 days , along with individual component of the success, will be presented.

  30 days

• Durability of the second aortic THV (30 days)

  Determine the durability of the second aortic THV: * Subclinical transcatheter heart valve thrombosis at thirty days (when it becomes apparent, but no systematic screening) * Endocarditis Definition of transcatheter heart valve thrombosis Clinical sequelae of a thromboembolic event (e.g. stroke, TIA, retinal occlusion, other evidence of systemic thromboembolism) or worsening valve stenosis/ regurgitation (e.g. signs of heart failure, syncope) and * Haemodynamic valve deterioration Stage 2 or 3 or * Confirmatory imaging (CT evidence of HALT† or TEE findings) In the absence of clinical sequelae, both * Haemodynamic valve deterioration Stage 3 and * Confirmatory imaging (CT evidence of HALT or TEE findings) Number and percentage of subjects with above specified criteria at 3 months, along with individual component of the success, will be presented.

  30 days

• Durability of the second aortic THV (3 months)

  Determine the durability of the second aortic THV: * Subclinical transcatheter heart valve thrombosis at three months (if data obtained, when it becomes apparent, but no systematic screening) * Clinical transcatheter heart valve thrombosis at three months (if data obtained) * Endocarditis For the definition of transcatheter cardiac valve thrombosis, please refer to Outcome 5. Number and percentage of subjects with above specified criteria at 3 months, along with individual component of the success, will be presented.

  3 months

• Durability of the second aortic THV (12 months)

  Determine the durability of the second aortic THV: * Subclinical transcatheter heart valve thrombosis at twelve months (when it becomes apparent, but no systematic screening) * Clinical transcatheter heart valve thrombosis at twelve months * All-cause mortality, stroke, myocardial infarction, and cardiovascular hospitalization at twelve months * Stage II or III structural valve degeneration according to VARC 3 definitions at twelve months (stage I may be documented) * Endocarditis For the definition of transcatheter cardiac valve thrombosis, please refer to Outcome 5. Number and percentage of subjects with above specified criteria at 12 months , along with individual component of the success, will be presented.

  12 months

• Durability of the second aortic THV (3 years)

  Determine the durability of the second aortic THV: * Subclinical transcatheter heart valve thrombosis at 3 years (when it becomes apparent, but no systematic screening) * Clinical transcatheter heart valve thrombosis at 3 years * All-cause mortality, stroke, myocardial infarction, and cardiovascular hospitalization at 3 years For the definition of transcatheter cardiac valve thrombosis, please refer to Outcome 5.

  3 years

• Durability of the second aortic THV (5 years)

  Determine the durability of the second aortic THV: * Subclinical transcatheter heart valve thrombosis at 5 years (when it becomes apparent, but no systematic screening) * Clinical transcatheter heart valve thrombosis at 5 years * All-cause mortality, stroke, myocardial infarction, and cardiovascular hospitalization at 5 years For the definition of transcatheter cardiac valve thrombosis, please refer to Outcome 5.

  5 years

Other Outcomes (4)

• Compliance with recommendation

  12 months

• Impact of alterations to published recommendations

  12 months

• Discretionary longer-term follow-up

  up to 5 years

Study Arms (1)

redo-TAVI patients

Patients with severe aortic stenosis (sAS) treated with TAVI developing SVD and thus an indication for redo-TAVI procedure

Procedure: Elective redo transcatheter aortic valve implantation (redo-TAVI)

Interventions

Elective redo transcatheter aortic valve implantation (redo-TAVI) PROCEDURE

Elective redo-TAVI procedure with the intention to treat the patient with a SAPIEN family valve implantation (currently the only registered medical devices for redo-TAVI use)

Also known as: redo-TAVI, redo-TAVR, Valve-in-Valve (ViV), TAV-in-TAV, TAVR-in-TAVR, Revalve

redo-TAVI patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with an indication for a redo-TAVI procedure considered eligible by the Local Heart Team and the Case Review Board for a SAPIEN family valve implantation.

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Institut für Pharmakologie und Präventive Medizin: lead
• Edwards Lifesciences: collaborator

Study Sites (62)

LKH-University Hospital and Medical University of Graz

Graz, 8010, Austria

RECRUITING

Kepler University Clinic Linz

Linz, 4020, Austria

RECRUITING

University Hospital St. Pölten

Sankt Pölten, 3100, Austria

RECRUITING

Medical University of Vienna

Vienna, 1090, Austria

RECRUITING

McGill University Health Centre

Montreal, H4A 3J1, Canada

RECRUITING

Institut Universitaire de Cardiologie et de Pneumologie

Québec, QC G1V 4G5, Canada

RECRUITING

St. Paul's Hospital, Vancouver

Vancouver, BC V6Z 1Y6, Canada

RECRUITING

Centre Hospitalier Universitaire de Bordeaux

Bordeaux, 33604, France

RECRUITING

Centre Hospitalier Universitaire de Clermont-Ferrand

Clermont-Ferrand, 63003, France

RECRUITING

Centre Hospitalier Universitaire de Lille

Lille, 59037, France

RECRUITING

Hospices Civils de Lyon

Lyon, 69677, France

RECRUITING

Hôpitaux Universitaires de Marseille Timone

Marseille, 13005, France

RECRUITING

Jacques Cartier Private Hospital, Massy

Massy, 91300, France

RECRUITING

Centre Hospitalier Universitaire de Nantes

Nantes, 44093, France

RECRUITING

Hôpital Européen Georges-Pompidou

Paris, 75015, France

RECRUITING

Hôpital Bichat-Claude-Bernard

Paris, 75018, France

RECRUITING

Centre hospitalier universitaire de Rennes

Rennes, 35033, France

RECRUITING

Centre Hospitalier Universitaire de Rouen

Roubaix, 76000, France

RECRUITING

Clinique de la Porte de Paris (CCN)

Saint-Denis, 93200, France

RECRUITING

Centre Hospitalier Universitaire de Toulouse

Toulouse, 31059, France

RECRUITING

University Heart Center Freiburg Bad Krozingen

Bad Krozingen, 79189, Germany

RECRUITING

Kerckhoff-Klinik GmbH, UKGM GmbH

Bad Nauheim, 61231, Germany

RECRUITING

Heart and Diabetes Center North Rhine-Westphalia

Bad Oeynhausen, 32545, Germany

RECRUITING

German Heart Center of Charité Berlin

Berlin, 13353, Germany

RECRUITING

BG University Hospital Bergmannsheil gGmbH

Bochum, 44789, Germany

RECRUITING

University Hospital of Duesseldorf

Düsseldorf, 40225, Germany

RECRUITING

Elisabeth Hospital, Essen

Essen, 45138, Germany

RECRUITING

German Heart Centre Munich

Munich, 80636, Germany

RECRUITING

Robert-Bosch-Hospital, Stuttgart

Stuttgart, 70376, Germany

RECRUITING

University Hospital Ulm

Ulm, 89070, Germany

RECRUITING

Tel Aviv Medical Center

Tel Aviv, 6423906, Israel

RECRUITING

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

Ancona, 60126, Italy

WITHDRAWN

IRCCS Azienda Ospedaliero Universitaria di Bologna

Bologna, 40138, Italy

RECRUITING

Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

Brescia, 25123, Italy

RECRUITING

Careggi Hospital

Florence, 50134, Italy

RECRUITING

IRCCS Ospedale Galeazzi Sant'Ambrogio

Milan, 20157, Italy

RECRUITING

Azienda Ospedale-Università Padova (AOUP)

Padua, 35128, Italy

RECRUITING

Azienda Ospedaliero-Universitaria Pisana

Pisa, 56124, Italy

RECRUITING

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Roma, 00168, Italy

RECRUITING

Policlinici universitari | Sapienza Università di Roma

Roma, 00185, Italy

RECRUITING

Università degli Studi di Trieste

Trieste, 34149, Italy

RECRUITING

Ospedale San Bortolo di Vicenza

Vicenza, 36100, Italy

RECRUITING

St. Antonius Ziekenhuis, Nieuwegein

Nieuwegein, 3435, Netherlands

RECRUITING

Medical University of Bialystok

Bialystok, 15-089, Poland

RECRUITING

University Clinical Centre of Gdańsk

Gdansk, 80-952, Poland

WITHDRAWN

Medical University of Silesia

Katowice, 40-055, Poland

WITHDRAWN

University Hospital of Kraków

Krakow, 31-501, Poland

RECRUITING

Medical University of Warsaw

Warsaw, 02-091, Poland

RECRUITING

Institute of Cardiology Warsaw

Warsaw, 04-628, Poland

RECRUITING

Wroclaw Medical University

Wroclaw, 50-368, Poland

RECRUITING

Hospital de Santa Cruz, Carnaxide-Lisabon

Carnaxide, 2790-134, Portugal

RECRUITING

Centro Hospitalar Vila Nova de Gaia / Espinho

Vila Nova de Gaia, 4434-502, Portugal

RECRUITING

Hospital de la Santa Creu i Sant Pau

Barcelona, 08025, Spain

RECRUITING

Hospital Clinic de Barcelona

Barcelona, 08036, Spain

RECRUITING

Hospital University Germans Trias i Pujol

Barcelona, 08916, Spain

RECRUITING

Hospital Universitario de León

León, 24008, Spain

RECRUITING

Hospital Clinico Universitario San Carlos

Madrid, 28040, Spain

RECRUITING

Hospital Universitario Central de Asturias

Oviedo, 33011, Spain

RECRUITING

Hospital Álvaro Cunqueiro, Vigo

Vigo, 36312, Spain

RECRUITING

University Hospital of Basel

Basel, 4031, Switzerland

RECRUITING

Hôpitaux universitaires de Genève

Geneva, 1205, Switzerland

RECRUITING

Centre hospitalier universitaire vaudois et Université de Lausanne

Lausanne, 1011, Switzerland

RECRUITING

Related Publications (9)

• VARC-3 WRITING COMMITTEE; Genereux P, Piazza N, Alu MC, Nazif T, Hahn RT, Pibarot P, Bax JJ, Leipsic JA, Blanke P, Blackstone EH, Finn MT, Kapadia S, Linke A, Mack MJ, Makkar R, Mehran R, Popma JJ, Reardon M, Rodes-Cabau J, Van Mieghem NM, Webb JG, Cohen DJ, Leon MB. Valve Academic Research Consortium 3: updated endpoint definitions for aortic valve clinical research. Eur Heart J. 2021 May 14;42(19):1825-1857. doi: 10.1093/eurheartj/ehaa799.

  PMID: 33871579 BACKGROUND

• Tarantini G, Delgado V, de Backer O, Sathananthan J, Treede H, Saia F, Blackman D, Parma R. Redo-Transcatheter Aortic Valve Implantation Using the SAPIEN 3/Ultra Transcatheter Heart Valves-Expert Consensus on Procedural Planning and Techniques. Am J Cardiol. 2023 Apr 1;192:228-244. doi: 10.1016/j.amjcard.2023.01.010. Epub 2023 Jan 27.

  PMID: 36710143 BACKGROUND

• Leon MB, Smith CR, Mack M, Miller DC, Moses JW, Svensson LG, Tuzcu EM, Webb JG, Fontana GP, Makkar RR, Brown DL, Block PC, Guyton RA, Pichard AD, Bavaria JE, Herrmann HC, Douglas PS, Petersen JL, Akin JJ, Anderson WN, Wang D, Pocock S; PARTNER Trial Investigators. Transcatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery. N Engl J Med. 2010 Oct 21;363(17):1597-607. doi: 10.1056/NEJMoa1008232. Epub 2010 Sep 22.

  PMID: 20961243 BACKGROUND

• Smith CR, Leon MB, Mack MJ, Miller DC, Moses JW, Svensson LG, Tuzcu EM, Webb JG, Fontana GP, Makkar RR, Williams M, Dewey T, Kapadia S, Babaliaros V, Thourani VH, Corso P, Pichard AD, Bavaria JE, Herrmann HC, Akin JJ, Anderson WN, Wang D, Pocock SJ; PARTNER Trial Investigators. Transcatheter versus surgical aortic-valve replacement in high-risk patients. N Engl J Med. 2011 Jun 9;364(23):2187-98. doi: 10.1056/NEJMoa1103510. Epub 2011 Jun 5.

  PMID: 21639811 BACKGROUND

• Toggweiler S, Wood DA, Rodes-Cabau J, Kapadia S, Willson AB, Ye J, Cheung A, Leipsic J, Binder RK, Gurvitch R, Freeman M, Thompson CR, Svensson LG, Dumont E, Tuzcu EM, Webb JG. Transcatheter valve-in-valve implantation for failed balloon-expandable transcatheter aortic valves. JACC Cardiovasc Interv. 2012 May;5(5):571-577. doi: 10.1016/j.jcin.2012.03.008.

  PMID: 22625197 BACKGROUND

• Kamioka N, Caughron H, Corrigan F, Block P, Babaliaros V. Supra-annular valve strategy for an early degenerated transcatheter balloon-expandable heart valve. Catheter Cardiovasc Interv. 2018 Dec 1;92(7):1458-1460. doi: 10.1002/ccd.27506. Epub 2018 Jan 23.

  PMID: 29359409 BACKGROUND

• Webb JG, Mack MJ, White JM, Dvir D, Blanke P, Herrmann HC, Leipsic J, Kodali SK, Makkar R, Miller DC, Pibarot P, Pichard A, Satler LF, Svensson L, Alu MC, Suri RM, Leon MB. Transcatheter Aortic Valve Implantation Within Degenerated Aortic Surgical Bioprostheses: PARTNER 2 Valve-in-Valve Registry. J Am Coll Cardiol. 2017 May 9;69(18):2253-2262. doi: 10.1016/j.jacc.2017.02.057.

  PMID: 28473128 BACKGROUND

• Deeb GM, Chetcuti SJ, Reardon MJ, Patel HJ, Grossman PM, Schreiber T, Forrest JK, Bajwa TK, O'Hair DP, Petrossian G, Robinson N, Katz S, Hartman A, Dauerman HL, Schmoker J, Khabbaz K, Watson DR, Yakubov SJ, Oh JK, Li S, Kleiman NS, Adams DH, Popma JJ. 1-Year Results in Patients Undergoing Transcatheter Aortic Valve Replacement With Failed Surgical Bioprostheses. JACC Cardiovasc Interv. 2017 May 22;10(10):1034-1044. doi: 10.1016/j.jcin.2017.03.018.

  PMID: 28521921 BACKGROUND

• Kopp-Schneider A, Wiesenfarth M, Witt R, Edelmann D, Witt O, Abel U. Monitoring futility and efficacy in phase II trials with Bayesian posterior distributions-A calibration approach. Biom J. 2019 May;61(3):488-502. doi: 10.1002/bimj.201700209. Epub 2018 Sep 2.

  PMID: 30175405 BACKGROUND

Related Links

• The ReTAVi Registry webpage provides you with general details about the trial and gives you an overview of participating trial sites.

MeSH Terms

Conditions

Prosthesis Failure

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Giuseppe Tarantini, Prof.

  University of Padua Medical School, Padua, Italy

  PRINCIPAL INVESTIGATOR

• Radoslaw Parma, Dr.

  Medical University of Silesia, Katowice, Poland

  PRINCIPAL INVESTIGATOR

• Thomas Cuisset, Prof.

  Centre Hospitalier Universitaire de Timone, Marseille, France

  STUDY CHAIR

• Victoria Delgado, Prof.

  University Hospital Germans Trias i Pujol, Badalona, Spain

  STUDY CHAIR

• Michael Joner, Prof.

  German Heart Center, Technical University of Munich, Munich, Germany

  STUDY CHAIR

• Thomas Modine, Prof.

  Hopital Haut Levêque - Centre Hospitalier Universitaire de Bordeaux, France

  STUDY CHAIR

• Josep Rodés-Cabau, Prof.

  nstitut Universitaire de Cardiologie et de Pneumologie de Québec, Canada

  STUDY CHAIR

• Francesco Saia, Prof.

  University Hospital of Bologna, Policlinico S. Orsola-Malpighi, Bologna, Italy

  STUDY CHAIR

• Hector A. Alvarez Covarrubias, MD

  Department of Cardiology, Munich Heart Center, Technical University of Munich, Germany

  STUDY CHAIR

• Ginatutas Bieliauskas, MD

  Department Interventional Cardiology, The Heart Center, Rigshospitalet, University of Copenhagen, Coppenhagen, Denmark

  STUDY CHAIR

• Luca Nai Fovino, MD

  Department of Cardiac, Thoracic, Vascular Sciences and Public Health, University of Padua Medical School, Padua, Italy

  STUDY CHAIR

• Eric Van Belle, MD

  Interventional Cardiology, Centre Hospitalier Universitaire de Lille, France

  STUDY CHAIR

• Rafał Wolny, MD

  Department of Interventional Cardiology and Angiology, National Institute of Cardiology, Warsaw, Poland

  STUDY CHAIR

Central Study Contacts

Claudia Lüske, PhD

CONTACT

044718503324; claudia.lueske@ippmed.de

Daniel Greinert

CONTACT

044718503328; daniel.greinert@ippmed.de

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2022
• First Posted: November 1, 2022
• Study Start: September 5, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2031
• Last Updated: August 20, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

ES (7); CA (3); DE (10); AU (4); IL (1); PT (2); FR (13); CH (3); IT (11); NL (1); PL (7)