REdo Transcatheter Aortic VALVE Implantation for the Management of Transcatheter Aortic Valve Failure

Official title

Prospective, Multi-centre Clinical Investigation Evaluating the Outcomes of Patients Treated by Redo Transcatheter Aortic Valve Implantation for Bioprosthetic Valve Failure of a Transcatheter Aortic Valve

Overview

Transcatheter aortic valve implantation (TAVI) is a key-hole technique to replace an aortic heart valve that is narrowed and/or leaking. Although TAVI is a safe and effective treatment for a faulty aortic heart valve, the new TAVI valve will not last forever. Because it is a 'tissue' valve (made from the lining of a cow or pig heart), the valve will fail after a period of time as the tissue degenerates. 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.

Detailed description

To determine the acute and long-term outcomes of Redo Transcatheter Aortic Valve Implantation (TAVI) for the treatment of Bioprosthetic Valve Failure (BVF) affecting Transcatheter Aortic Heart Valves (THVs)

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)

Interventions

• Device 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.
• Procedure 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 discre
• Other Conservative management
  Conservative treatment, including optimal medical therapy +/- balloon aortic valvuloplasty

Primary outcome measures

• REVALVE success (Redo TAVI) [Time frame: 30 days]
• Freedom from death/stroke/re-hospitalisation for valve or procedure-related causes (Redo TAVI) [Time frame: 12 months]
• Valve Academic Research Consortium 3 (VARC3) Early Safety (EXPLANT) [Time frame: 30 days]
• Freedom from death/stroke/re-hospitalisation for valve or procedure-related causes (EXPLANT) [Time frame: 12 months]
• Freedom from death/stroke/re-hospitalisation for valve or procedure-related causes (OMT) [Time frame: 12 months]

Secondary outcome measures (12)

• Valve Academic Research Consortium 3 (VARC3) Technical Success (Redo TAVI and EXPLANT) [Time frame: End of procedure]
• Valve Academic Research Consortium 3 (VARC3) Device Success (Redo TAVI and EXPLANT) [Time frame: 30 days]
• Valve Academic Research Consortium 3 (VARC3) Early Safety (Redo TAVI) [Time frame: 30 days]
• Peak and mean invasive gradient post-procedure (Redo TAVI) [Time frame: End of procedure]
• In-hospital Clinical Outcomes [Time frame: Immediately after the procedure/surgery]
• Echocardiographic Assessment: Peak velocity [Time frame: Pre-discharge or at 30 days, 1, 3, 5 years]
• Echocardiographic Assessment: Mean gradient [Time frame: Pre-discharge or at 30 days, 1, 3, 5 years]
• Echocardiographic Assessment: Aortic valve area [Time frame: Pre-discharge or at 30 days, 1, 3, 5 years]
• Echocardiographic Assessment: Patient-prosthesis mismatch [Time frame: Pre-discharge or at 30 days]
• Echocardiographic Assessment: Aortic Regurgitation - paravalvular, transvalvular or total [Time frame: Pre-discharge or at 30 days, 1, 3, 5 years]
• Echocardiographic Assessment: Left ventricular systolic function [Time frame: Pre-discharge or at 30 days, 1, 3, 5 years]
• Clinical Outcomes [Time frame: 1, 3 and 5 years]

Eligibility criteria

Inclusion criteria

1\. Bio-prosthetic Valve Failure (BVF) of a Transcatheter Aortic Valve requiring possible reintervention

Exclusion criteria

• Bio-prosthetic Valve Failure due solely to paravalvular aortic regurgitation
• Active endocarditis
• Untreated acute valve thrombosis
• Life-expectancy less than 1 year
• Subject is less than legal age of consent, legally incompetent, or otherwise vulnerable
• Pregnant or nursing

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

Germany · 14 centers

• Kerckhoff Klinik — Bad Nauheim
• Herz- und Diabeteszentrum NRW — Bad Oeynhausen
• Deutsches Herzzentrum Berlin — Berlin
• Universitatsklinikum Koln (AoR) — Cologne
• Klinikum Dortmund GmbH - St. Johannes Hospital — Dortmund
• Herzzentrum Dresden Universitätsklinik — Dresden
• Universitatsklinikum Dusseldorf (University Hospital Dusseldorf) — Düsseldorf
• Universitatsklinikum Frankfurt — Frankfurt
• … and 6 more centers

United Kingdom · 14 centers

• Queen Elizabeth Hospital — Birmingham
• Royal Sussex County Hospital — Brighton
• Bristol Royal Infirmary — Bristol
• University Hospital of Wales — Cardiff
• Golden Jubilee National Hospital — Glasgow
• Leeds Teaching Hospitals NHS Trust — Leeds
• Glenfield Hospital — Leicester
• Guys and St Thomas' NHS Foundation Trust — London
• … and 6 more centers

France · 12 centers

• Clinical Saint Augustin - Elsan — Bordeaux
• Brest University Hospital Centre — Brest
• Henri Mondor University Hospital — Créteil
• ICPS Hôpital privé Jacques-Cartier — Massy
• Centre Hospitalier Universitaire de Montpellier — Montpellier
• University Hospital of Nimes — Nîmes
• Hospital Marie Lannelongue — Paris
• Institute Mutualiste Montsouris — Paris
• … and 4 more centers

Italy · 11 centers

• ASST Spedali Civili Di Brescia — Brescia
• Fondazione Poliambulanza Istituto Ospedaliero — Brescia
• Azienda Ospedaliero Universitaria Policlinico Vittorio Emanuele — Catania
• Ospedale San Martino - IRCCS Ospedale Policlinico — Genova
• Centro Cardiologico Monzino — Milan
• Humanitas Research Hospital - RCCS Istituto Clinico Humanitas di Milano — Milan
• IRCCS Ospedale San Raffaele — Milan
• Istituto Mediterraneo per i Trapianti Ismett IRCCS — Palermo
• … and 3 more centers

Netherlands · 4 centers

• Amphia Hospital — Breda
• Maastricht University Medical Center (MUMC) — Maastricht
• Radboud Universitair Medisch Centrum — Nijmegen
• Erasmus University Medical Center — Rotterdam

Sweden · 4 centers

• Sahlgrenska University Hospital — Gothenburg
• Skånes Universitetssjukhus Lund — Lund
• Nya Karolinska Sjukhuset Solna — Solna
• Uppsala University — Uppsala

Denmark · 3 centers

• Aalborg Universitethospital — Aalborg
• Århus Universitetshospital — Aarhus
• Rigshospitalet — Copenhagen

Israel · 3 centers

• Edith Wolfson Medical Center — Holon
• Shaare Zedek Medical Center — Jerusalem
• Rabin Medical Center - Belinson Campus — Petah Tikva

Finland · 2 centers

• HUS Helsinki University Hospital — Helsinki
• Turku University Hospital — Turku

Norway · 2 centers

• Haukeland Sykehus — Bergen
• Oslo University Hospital — Oslo

Switzerland · 2 centers

• Inselspital - Universitätsspital Bern — Bern
• Luzerner Kantonsspital — Lucerne

Publications

• 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 Rep PMID 30883053
• 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. PMID 30883058
• 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 PMID 34453165
• 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. Circula PMID 33332149
• 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. PMID 33284653
• 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. PMID 34556271
• 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. PMID 30025572
• 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 PMID 34092097

Identifiers

NCT: NCT06557798 · CD23/157535

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗