REdo Transcatheter Aortic VALVE Implantation for the Management of Transcatheter Aortic Valve Failure
NCT ID: NCT06557798
Last Updated: 2026-02-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
550 participants
OBSERVATIONAL
2024-12-12
2033-03-31
Brief Summary
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When the TAVI valve fails, a viable treatment option is to perform a 'Redo TAVI' procedure, implanting a second TAVI valve inside the first failing valve.
The main purpose of this study is to carefully evaluate patients being treated by Redo TAVI in order to document the short-term and long-term outcomes of the procedure. The study will also obtain information about which factors predict those outcomes.
The study will also assess outcomes in patients who present with TAVI valve failure but are not suitable for Redo TAVI, and instead are treated either by open-heart surgery and surgical aortic valve replacement, or by medical therapy (medication).
The study will provide doctors the information they need to understand the best way to treat patients who present with TAVI valve failure, and in particular how to perform Redo TAVI procedures with the best possible outcomes for patients.
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Detailed Description
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To determine the factors which predict the acute and long-term outcomes of Redo TAVI
To determine the proportion of patients presenting with BVF affecting THVs who are deemed unsuitable for Redo TAVI by the Heart Team
To determine the acute and long-term outcomes of surgical explantation and aortic valve replacement (AVR) for the treatment of BVF affecting THVs
To determine the survival of patients presenting with BVF affecting THVs who are managed conservatively - including optimal medical therapy (OMT) +/- balloon aortic valvuloplasty (BAV)
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Redo TAVI
Redo Trans-catheter Aortic Valve Implantation for Bioprosthetic Valve Failure of a Trans-catheter Aortic Valve
Any commercially available Edwards or Medtronic transcatheter aortic valve with the TAV-in-TAV (Redo TAVI) indication
Redo TAVI will be performed using any commercially available Edwards or Medtronic transcatheter aortic valve platforms that have the TAV-in-TAV (Redo TAVI) indication according to the preferences of the local team in keeping with standard clinical care.
Explant
Surgical explantation with aortic valve replacement
Surgical explantation and aortic valve replacement
Surgical explantation of all or part of the index transcatheter aortic valve, with open implantation of a new surgical or transcatheter aortic valve replacement will be performed according to the preferences of the local team in keeping with standard clinical care. Any commercially available approved surgical or transcatheter aortic valve may be used. Additional surgery, such as aortic root replacement, root enlargement, CABG, mitral valve repair/replacement, etc. will be performed at the discretion of the local team.
Optimal Medical Therapy
Conservative treatment, including optimal medical therapy +/- balloon aortic valvuloplasty
Conservative management
Conservative treatment, including optimal medical therapy +/- balloon aortic valvuloplasty
Interventions
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Any commercially available Edwards or Medtronic transcatheter aortic valve with the TAV-in-TAV (Redo TAVI) indication
Redo TAVI will be performed using any commercially available Edwards or Medtronic transcatheter aortic valve platforms that have the TAV-in-TAV (Redo TAVI) indication according to the preferences of the local team in keeping with standard clinical care.
Surgical explantation and aortic valve replacement
Surgical explantation of all or part of the index transcatheter aortic valve, with open implantation of a new surgical or transcatheter aortic valve replacement will be performed according to the preferences of the local team in keeping with standard clinical care. Any commercially available approved surgical or transcatheter aortic valve may be used. Additional surgery, such as aortic root replacement, root enlargement, CABG, mitral valve repair/replacement, etc. will be performed at the discretion of the local team.
Conservative management
Conservative treatment, including optimal medical therapy +/- balloon aortic valvuloplasty
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
2. Active endocarditis
3. Untreated acute valve thrombosis
4. Life-expectancy less than 1 year
5. Subject is less than legal age of consent, legally incompetent, or otherwise vulnerable
6. Pregnant or nursing
18 Years
ALL
No
Sponsors
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Medtronic
INDUSTRY
NAMSA
OTHER
The Leeds Teaching Hospitals NHS Trust
OTHER
Responsible Party
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Principal Investigators
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Daniel Blackman, MD
Role: PRINCIPAL_INVESTIGATOR
Leeds Teaching Hospitals NHS Trust
Locations
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Aalborg Universitethospital
Aalborg, , Denmark
Århus Universitetshospital
Aarhus, , Denmark
Rigshospitalet
Copenhagen, , Denmark
HUS Helsinki University Hospital
Helsinki, , Finland
Turku University Hospital
Turku, , Finland
Clinical Saint Augustin - Elsan
Bordeaux, , France
Brest University Hospital Centre
Brest, , France
Henri Mondor University Hospital
Créteil, , France
ICPS Hôpital privé Jacques-Cartier
Massy, , France
Hospital Marie Lannelongue
Paris, , France
Institute Mutualiste Montsouris
Paris, , France
Les Hospital Universitaires de Strasbourg
Strasbourg, , France
Clinique Pasteur Toulouse
Toulouse, , France
CHRU Hospitals of Tours
Tours, , France
Medipole Lyon-Villeurbanne
Villeurbanne, , France
Kerckhoff Klinik
Bad Nauheim, , Germany
Herz- und Diabeteszentrum NRW
Bad Oeynhausen, , Germany
Klinikum Dortmund GmbH - St. Johannes Hospital
Dortmund, , Germany
Herzzentrum Dresden Universitätsklinik
Dresden, , Germany
Universitatsklinikum Frankfurt
Frankfurt, , Germany
Universitätsklinikum Schleswig-Holstein (UKSH)
Kiel, , Germany
HELIOS Herzzentrum Leipzig GmbH
Leipzig, , Germany
Universitätsklinikum Schleswig-Holstein (UKSH)
Lübeck, , Germany
LMU Klinikum
München, , Germany
Shaare Zedek Medical Center
Jerusalem, , Israel
Azienda Ospedaliero Universitaria Policlinico Vittorio Emanuele
Catania, , Italy
Centro Cardiologico Monzino
Milan, , Italy
IRCSS Policlinico San Donato
San Donato Milanese, , Italy
Ospedale Borgo Trento - Azienda Ospedaliera Universitaria Integrata Verona
Verona, , Italy
Amphia Hospital
Breda, , Netherlands
Maastricht University Medical Center (MUMC)
Maastricht, , Netherlands
Erasmus University Medical Center
Rotterdam, , Netherlands
Haukeland Sykehus
Bergen, , Norway
Oslo University Hospital
Oslo, , Norway
Sahlgrenska University Hospital
Gothenburg, , Sweden
Skånes Universitetssjukhus Lund
Lund, , Sweden
Nya Karolinska Sjukhuset Solna
Solna, , Sweden
Inselspital - Universitätsspital Bern
Bern, , Switzerland
Luzerner Kantonsspital
Lucerne, , Switzerland
Queen Elizabeth Hospital
Birmingham, , United Kingdom
Royal Sussex County Hospital
Brighton, , United Kingdom
Bristol Royal Infirmary
Bristol, , United Kingdom
University Hospital of Wales
Cardiff, , United Kingdom
Golden Jubilee National Hospital
Glasgow, , United Kingdom
Leeds Teaching Hospitals NHS Trust
Leeds, , United Kingdom
Glenfield Hospital
Leicester, , United Kingdom
Guys and St Thomas' NHS Foundation Trust
London, , United Kingdom
St. George's Hospital
London, , United Kingdom
Manchester Royal Infirmary
Manchester, , United Kingdom
Freeman Hospital
Newcastle upon Tyne, , United Kingdom
Oxford University Hospitals NHS Foundation Trust
Oxford, , United Kingdom
University Hospital Southampton NHS Foundation Trust
Southampton, , United Kingdom
New Cross Hospital
Wolverhampton, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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References
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Fukuhara S, Brescia AA, Deeb GM. Surgical Explantation of Transcatheter Aortic Bioprostheses: An Analysis From the Society of Thoracic Surgeons Database. Circulation. 2020 Dec 8;142(23):2285-2287. doi: 10.1161/CIRCULATIONAHA.120.050499. Epub 2020 Dec 7. No abstract available.
Popma JJ, Deeb GM, Yakubov SJ, Mumtaz M, Gada H, O'Hair D, Bajwa T, Heiser JC, Merhi W, Kleiman NS, Askew J, Sorajja P, Rovin J, Chetcuti SJ, Adams DH, Teirstein PS, Zorn GL 3rd, Forrest JK, Tchetche D, Resar J, Walton A, Piazza N, Ramlawi B, Robinson N, Petrossian G, Gleason TG, Oh JK, Boulware MJ, Qiao H, Mugglin AS, Reardon MJ; Evolut Low Risk Trial Investigators. Transcatheter Aortic-Valve Replacement with a Self-Expanding Valve in Low-Risk Patients. N Engl J Med. 2019 May 2;380(18):1706-1715. doi: 10.1056/NEJMoa1816885. Epub 2019 Mar 16.
Mack MJ, Leon MB, Thourani VH, Makkar R, Kodali SK, Russo M, Kapadia SR, Malaisrie SC, Cohen DJ, Pibarot P, Leipsic J, Hahn RT, Blanke P, Williams MR, McCabe JM, Brown DL, Babaliaros V, Goldman S, Szeto WY, Genereux P, Pershad A, Pocock SJ, Alu MC, Webb JG, Smith CR; PARTNER 3 Investigators. Transcatheter Aortic-Valve Replacement with a Balloon-Expandable Valve in Low-Risk Patients. N Engl J Med. 2019 May 2;380(18):1695-1705. doi: 10.1056/NEJMoa1814052. Epub 2019 Mar 16.
Vahanian A, Beyersdorf F, Praz F, Milojevic M, Baldus S, Bauersachs J, Capodanno D, Conradi L, De Bonis M, De Paulis R, Delgado V, Freemantle N, Gilard M, Haugaa KH, Jeppsson A, Juni P, Pierard L, Prendergast BD, Sadaba JR, Tribouilloy C, Wojakowski W; ESC/EACTS Scientific Document Group. 2021 ESC/EACTS Guidelines for the management of valvular heart disease. Eur Heart J. 2022 Feb 12;43(7):561-632. doi: 10.1093/eurheartj/ehab395. No abstract available.
Otto CM, Nishimura RA, Bonow RO, Carabello BA, Erwin JP 3rd, Gentile F, Jneid H, Krieger EV, Mack M, McLeod C, O'Gara PT, Rigolin VH, Sundt TM 3rd, Thompson A, Toly C. 2020 ACC/AHA Guideline for the Management of Patients With Valvular Heart Disease: Executive Summary: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. Circulation. 2021 Feb 2;143(5):e35-e71. doi: 10.1161/CIR.0000000000000932. Epub 2020 Dec 17.
Bapat VN, Zaid S, Fukuhara S, Saha S, Vitanova K, Kiefer P, Squiers JJ, Voisine P, Pirelli L, von Ballmoos MW, Chu MWA, Rodes-Cabau J, DiMaio JM, Borger MA, Lange R, Hagl C, Denti P, Modine T, Kaneko T, Tang GHL; EXPLANT-TAVR Investigators. Surgical Explantation After TAVR Failure: Mid-Term Outcomes From the EXPLANT-TAVR International Registry. JACC Cardiovasc Interv. 2021 Sep 27;14(18):1978-1991. doi: 10.1016/j.jcin.2021.07.015.
Tuzcu EM, Kapadia SR, Vemulapalli S, Carroll JD, Holmes DR Jr, Mack MJ, Thourani VH, Grover FL, Brennan JM, Suri RM, Dai D, Svensson LG. Transcatheter Aortic Valve Replacement of Failed Surgically Implanted Bioprostheses: The STS/ACC Registry. J Am Coll Cardiol. 2018 Jul 24;72(4):370-382. doi: 10.1016/j.jacc.2018.04.074.
Testa L, Agnifili M, Van Mieghem NM, Tchetche D, Asgar AW, De Backer O, Latib A, Reimers B, Stefanini G, Trani C, Colombo A, Giannini F, Bartorelli A, Wojakowski W, Dabrowski M, Jagielak D, Banning AP, Kharbanda R, Moreno R, Schofer J, van Royen N, Pinto D, Serra A, Segev A, Giordano A, Brambilla N, Popolo Rubbio A, Casenghi M, Oreglia J, De Marco F, Tanja R, McCabe JM, Abizaid A, Voskuil M, Teles R, Biondi Zoccai G, Bianchi G, Sondergaard L, Bedogni F. Transcatheter Aortic Valve Replacement for Degenerated Transcatheter Aortic Valves: The TRANSIT International Project. Circ Cardiovasc Interv. 2021 Jun;14(6):e010440. doi: 10.1161/CIRCINTERVENTIONS.120.010440. Epub 2021 Jun 7.
Landes U, Sathananthan J, Witberg G, De Backer O, Sondergaard L, Abdel-Wahab M, Holzhey D, Kim WK, Hamm C, Buzzatti N, Montorfano M, Ludwig S, Conradi L, Seiffert M, Guerrero M, El Sabbagh A, Rodes-Cabau J, Guimaraes L, Codner P, Okuno T, Pilgrim T, Fiorina C, Colombo A, Mangieri A, Eltchaninoff H, Nombela-Franco L, Van Wiechen MPH, Van Mieghem NM, Tchetche D, Schoels WH, Kullmer M, Tamburino C, Sinning JM, Al-Kassou B, Perlman GY, Danenberg H, Ielasi A, Fraccaro C, Tarantini G, De Marco F, Redwood SR, Lisko JC, Babaliaros VC, Laine M, Nerla R, Castriota F, Finkelstein A, Loewenstein I, Eitan A, Jaffe R, Ruile P, Neumann FJ, Piazza N, Alosaimi H, Sievert H, Sievert K, Russo M, Andreas M, Bunc M, Latib A, Godfrey R, Hildick-Smith D, Chuang MA, Blanke P, Leipsic J, Wood DA, Nazif TM, Kodali S, Barbanti M, Kornowski R, Leon MB, Webb JG. Transcatheter Replacement of Transcatheter Versus Surgically Implanted Aortic Valve Bioprostheses. J Am Coll Cardiol. 2021 Jan 5;77(1):1-14. doi: 10.1016/j.jacc.2020.10.053.
Forrestal BJ, Case BC, Yerasi C, Shea C, Torguson R, Zhang C, Ben-Dor I, Deksissa T, Ali S, Satler LF, Shults C, Weissman G, Wang JC, Khan JM, Waksman R, Rogers T. Risk of Coronary Obstruction and Feasibility of Coronary Access After Repeat Transcatheter Aortic Valve Replacement With the Self-Expanding Evolut Valve: A Computed Tomography Simulation Study. Circ Cardiovasc Interv. 2020 Dec;13(12):e009496. doi: 10.1161/CIRCINTERVENTIONS.120.009496. Epub 2020 Dec 4.
Ochiai T, Oakley L, Sekhon N, Komatsu I, Flint N, Kaewkes D, Yoon SH, Raschpichler M, Patel V, Tiwana R, Enta Y, Mahani S, Kim Y, Stegic J, Chakravarty T, Nakamura M, Cheng W, Makkar R. Risk of Coronary Obstruction Due to Sinus Sequestration in Redo Transcatheter Aortic Valve Replacement. JACC Cardiovasc Interv. 2020 Nov 23;13(22):2617-2627. doi: 10.1016/j.jcin.2020.09.022.
Landes U, Richter I, Danenberg H, Kornowski R, Sathananthan J, De Backer O, Sondergaard L, Abdel-Wahab M, Yoon SH, Makkar RR, Thiele H, Kim WK, Hamm C, Buzzatti N, Montorfano M, Ludwig S, Schofer N, Voigtlaender L, Guerrero M, El Sabbagh A, Rodes-Cabau J, Mesnier J, Okuno T, Pilgrim T, Fiorina C, Colombo A, Mangieri A, Eltchaninoff H, Nombela-Franco L, Van Wiechen MPH, Van Mieghem NM, Tchetche D, Schoels WH, Kullmer M, Barbanti M, Tamburino C, Sinning JM, Al-Kassou B, Perlman GY, Ielasi A, Fraccaro C, Tarantini G, De Marco F, Witberg G, Redwood SR, Lisko JC, Babaliaros VC, Laine M, Nerla R, Finkelstein A, Eitan A, Jaffe R, Ruile P, Neumann FJ, Piazza N, Sievert H, Sievert K, Russo M, Andreas M, Bunc M, Latib A, Bruoha S, Godfrey R, Hildick-Smith D, Barbash I, Segev A, Maurovich-Horvat P, Szilveszter B, Spargias K, Aravadinos D, Nazif TM, Leon MB, Webb JG. Outcomes of Redo Transcatheter Aortic Valve Replacement According to the Initial and Subsequent Valve Type. JACC Cardiovasc Interv. 2022 Aug 8;15(15):1543-1554. doi: 10.1016/j.jcin.2022.05.016. Epub 2022 Jul 13.
Carroll JD, Mack MJ, Vemulapalli S, Herrmann HC, Gleason TG, Hanzel G, Deeb GM, Thourani VH, Cohen DJ, Desai N, Kirtane AJ, Fitzgerald S, Michaels J, Krohn C, Masoudi FA, Brindis RG, Bavaria JE. STS-ACC TVT Registry of Transcatheter Aortic Valve Replacement. Ann Thorac Surg. 2021 Feb;111(2):701-722. doi: 10.1016/j.athoracsur.2020.09.002. Epub 2020 Nov 16.
Blackman DJ, Aktaa S, Pickles D, Abdel-Wahab M, De Backer O, Van Mieghem NM, Treede H, Landes U, Bapat V, Hildick-Smith D, Barbanti M. REdo transcatheter aortic VALVE implantation for the management of transcatheter aortic valve failure: Design and rationale of the REVALVE study. Int J Cardiol. 2025 Sep 15;435:133400. doi: 10.1016/j.ijcard.2025.133400. Epub 2025 May 18.
Other Identifiers
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CD23/157535
Identifier Type: -
Identifier Source: org_study_id
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