Aortic Valve StenosisREVALVENCT06557798
REdo Transcatheter Aortic VALVE Implantation for the Management of Transcatheter Aortic Valve Failure
An observational study of Aortic Valve Stenosis, run by The Leeds Teaching Hospitals NHS Trust at 76 sites in 11 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Valve Stenosis
- What is being tested?
- Any commercially available Edwards or Medtronic transcatheter aortic valve with the TAV-in-TAV (Redo TAVI) indication, Surgical explantation and aortic valve replacement and Conservative management
- Type of treatment
- Medical device, Surgery or procedure
- How many people
- 550 participants
- Where
- 76 sitesin 11 countries
- Study dates
- 12 Dec 2024to Mar 2033
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients presenting to the Heart Team with bio-prosthetic valve failure affecting a transcatheter aortic valve
Who may be able to join
- 1. Bio-prosthetic Valve Failure (BVF) of a Transcatheter Aortic Valve requiring possible reintervention
Who cannot join
- 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
Trial locations and contacts
76 sites in 11 countries. Contact the study team or a site near you to ask about taking part.
76 sites in 11 countries
Germany17 sites, 16 recruiting
- Recruiting
Kerckhoff Klinik
Bad Nauheim
- Recruiting
Herz- und Diabeteszentrum NRW
Bad Oeynhausen
- Withdrawn
Deutsches Herzzentrum Berlin
Berlin
- Recruiting
Universitatsklinikum Koln (AoR)
Cologne
- Recruiting
Klinikum Dortmund GmbH - St. Johannes Hospital
Dortmund
- Recruiting
Herzzentrum Dresden Universitätsklinik
Dresden
- Recruiting
Universitatsklinikum Dusseldorf (University Hospital Dusseldorf)
Düsseldorf
- Recruiting
Universitatsklinikum Frankfurt
Frankfurt
- Recruiting
Asklepios Klinik St. Georg
Hamburg
- Recruiting
Universitätsklinikum Schleswig-Holstein (UKSH)
Kiel
- Recruiting
HELIOS Herzzentrum Leipzig GmbH
Leipzig
- Recruiting
Universitätsklinikum Schleswig-Holstein (UKSH)
Lübeck
- Recruiting
Universitätsmedizin der Johannes
Mainz
- Recruiting
Deutsches Herzzentrum München (German Heartcentre Munich)
München
- Recruiting
LMU Klinikum
München
- Recruiting
Universitatsklinikum Tubingen
Tübingen
- Recruiting
Universitatsklinikum Ulm (University Hospital Ulm)
Ulm
France14 sites, 14 recruiting
- Recruiting
Clinical Saint Augustin - Elsan
Bordeaux
- Recruiting
Brest University Hospital Centre
Brest
- Recruiting
Henri Mondor University Hospital
Créteil
- Recruiting
ICPS Hôpital privé Jacques-Cartier
Massy
- Recruiting
Centre Hospitalier Universitaire de Montpellier
Montpellier
- Recruiting
University Hospital of Nimes
Nîmes
- Recruiting
Hospital Marie Lannelongue
Paris
- Recruiting
Institute Mutualiste Montsouris
Paris
- Recruiting
NCT - Saint-Gatien - Alliance
Saint-Cyr-sur-Loire
- Recruiting
Les Hospital Universitaires de Strasbourg
Strasbourg
- Recruiting
Centre Hospitalier Universitaire de Toulouse, Hospital Rangueil
Toulouse
- Recruiting
Clinique Pasteur Toulouse
Toulouse
- Recruiting
CHRU Hospitals of Tours
Tours
- Recruiting
Medipole Lyon-Villeurbanne
Villeurbanne
United Kingdom14 sites, 13 recruiting
- Recruiting
Queen Elizabeth Hospital
Birmingham
- Recruiting
Royal Sussex County Hospital
Brighton, BN2 1ES
- Recruiting
Bristol Royal Infirmary
Bristol
- Recruiting
University Hospital of Wales
Cardiff, CF14 4XW
- Recruiting
Golden Jubilee National Hospital
Glasgow
- Recruiting
Leeds Teaching Hospitals NHS Trust
Leeds, LS1 3EX
REVALVE Study Manager, 441132432799, revalve@nhs.net
- Recruiting
Glenfield Hospital
Leicester
- Recruiting
Guys and St Thomas' NHS Foundation Trust
London
- Recruiting
St. George's Hospital
London
- Withdrawn
Manchester Royal Infirmary
Manchester
- Recruiting
Freeman Hospital
Newcastle upon Tyne
- Recruiting
Oxford University Hospitals NHS Foundation Trust
Oxford, OX3 9DU
- Recruiting
University Hospital Southampton NHS Foundation Trust
Southampton, SO16 6YD
- Recruiting
New Cross Hospital
Wolverhampton
Italy11 sites, 10 recruiting
- Recruiting
ASST Spedali Civili Di Brescia
Brescia
- Recruiting
Fondazione Poliambulanza Istituto Ospedaliero
Brescia
- Recruiting
Azienda Ospedaliero Universitaria Policlinico Vittorio Emanuele
Catania
- Recruiting
Ospedale San Martino - IRCCS Ospedale Policlinico
Genova
- Recruiting
Centro Cardiologico Monzino
Milan
- Withdrawn
Humanitas Research Hospital - RCCS Istituto Clinico Humanitas di Milano
Milan
- Recruiting
IRCCS Ospedale San Raffaele
Milan
- Recruiting
Istituto Mediterraneo per i Trapianti Ismett IRCCS
Palermo
- Recruiting
IRCSS Policlinico San Donato
San Donato Milanese
- Recruiting
Azienda Ospedaliera Ordine Mauriziano di Torino
Torino
- Recruiting
Ospedale Borgo Trento - Azienda Ospedaliera Universitaria Integrata Verona
Verona
Netherlands4 sites, 3 recruiting
- Recruiting
Amphia Hospital
Breda
- Recruiting
Maastricht University Medical Center (MUMC)
Maastricht
- Withdrawn
Radboud Universitair Medisch Centrum
Nijmegen
- Recruiting
Erasmus University Medical Center
Rotterdam
Sweden4 sites, 4 recruiting
- Recruiting
Sahlgrenska University Hospital
Gothenburg
- Recruiting
Skånes Universitetssjukhus Lund
Lund
- Recruiting
Nya Karolinska Sjukhuset Solna
Solna
- Recruiting
Uppsala University
Uppsala
Denmark3 sites, 3 recruiting
- Recruiting
Aalborg Universitethospital
Aalborg
- Recruiting
Århus Universitetshospital
Aarhus
- Recruiting
Rigshospitalet
Copenhagen
Israel3 sites, 3 recruiting
- Recruiting
Edith Wolfson Medical Center
Holon
- Recruiting
Shaare Zedek Medical Center
Jerusalem
- Recruiting
Rabin Medical Center - Belinson Campus
Petah Tikva
Finland2 sites, 2 recruiting
- Recruiting
HUS Helsinki University Hospital
Helsinki
- Recruiting
Turku University Hospital
Turku
Norway2 sites, 2 recruiting
- Recruiting
Haukeland Sykehus
Bergen
- Recruiting
Oslo University Hospital
Oslo
Switzerland2 sites, 2 recruiting
- Recruiting
Inselspital - Universitätsspital Bern
Bern
- Recruiting
Luzerner Kantonsspital
Lucerne
About this study
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
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.
Read more
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.
Read the 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)
- Conditions
- Aortic Valve Stenosis
- Being tested
- Any commercially available Edwards or Medtronic transcatheter aortic valve with the TAV-in-TAV (Redo TAVI) indication, Surgical explantation and aortic valve replacement, Conservative management
- Keywords
- Bioprosthetic Valve Failure
- Medical subject headings
- Aortic Valve Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Any commercially available Edwards or Medtronic transcatheter aortic valve with the TAV-in-TAV (Redo TAVI) indicationDevice
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 replacementProcedure or surgery
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 managementOther
Conservative treatment, including optimal medical therapy +/- balloon aortic valvuloplasty
| Study group | Role | What they receive |
|---|---|---|
| Redo TAVI | Redo Trans-catheter Aortic Valve Implantation for Bioprosthetic Valve Failure of a Trans-catheter Aortic Valve Receives: Device: Any commercially available Edwards or Medtronic transcatheter aortic valve with the TAV-in-TAV (Redo TAVI) indication | |
| Explant | Surgical explantation with aortic valve replacement Receives: Procedure: Surgical explantation and aortic valve replacement | |
| Optimal Medical Therapy | Conservative treatment, including optimal medical therapy +/- balloon aortic valvuloplasty Receives: Other: Conservative management |
What is being measured
The primary outcome is the main question the study is designed to answer.
REVALVE success (Redo TAVI)
Correct positioning of a single prosthetic heart valve into the proper anatomic location, intended performance of the valve (mean gradient <20mmHg, peak velocity <3 m/s, Doppler velocity index ≥0.25. aortic regurgitation < moderate), Freedom from mortality, coronary obstruction, unplanned coronary revascularisation, surgery or intervention related to the device
Measured: 30 days
Freedom from death/stroke/re-hospitalisation for valve or procedure-related causes (Redo TAVI)
Composite outcome of freedom from death/stroke/re-hospitalisation for valve or procedure-related causes
Measured: 12 months
Valve Academic Research Consortium 3 (VARC3) Early Safety (EXPLANT)
Composite outcome of freedom from: death/stroke/VARC 3-4 bleeding/major vascular, access-related, or cardiac structural complication/AKI 3 or 4/moderate or severe AR/new permanent pacemaker/device-related surgery or intervention
Measured: 30 days
Freedom from death/stroke/re-hospitalisation for valve or procedure-related causes (EXPLANT)
Composite outcome of freedom from death/stroke/re-hospitalisation for valve or procedure-related causes
Measured: 12 months
Freedom from death/stroke/re-hospitalisation for valve or procedure-related causes (OMT)
Composite outcome of freedom from death/stroke/re-hospitalisation for valve or procedure-related causes
Measured: 12 months
Secondary outcomes (12)
Valve Academic Research Consortium 3 (VARC3) Technical Success (Redo TAVI and EXPLANT)
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 or to a major vascular or access-related, or cardiac structural complication
Measured: End of procedure
Valve Academic Research Consortium 3 (VARC3) Device Success (Redo TAVI and EXPLANT)
Technical success, Freedom from mortality, Freedom from surgery or intervention related to the device, or to 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, aortic regurgitation < moderate)
Measured: 30 days
Valve Academic Research Consortium 3 (VARC3) Early Safety (Redo TAVI)
Freedom from: death/stroke/VARC 2-4 bleeding (only VARC 3-4 for EXPLANT) /major vascular, access-related, or cardiac structural complication/Acute kidney injury (AKI) 3 or 4/moderate or severe Aortic Regurgitation/new permanent pacemaker/device-related surgery or intervention
Measured: 30 days
Peak and mean invasive gradient post-procedure (Redo TAVI)
Invasive pressure measurements
Measured: End of procedure
In-hospital Clinical Outcomes
All-cause mortality; All stroke; Myocardial infarction; Coronary artery obstruction; Unplanned coronary revascularisation (PCI or CABG); Bleeding (VARC 1-4); Major or minor Vascular and access-related complications; Cardiac structural complications; Permanent pacemaker implantation; Acute kidney injury (AKI) stage 1-4; Endocarditis; Clinically significant valve thrombosis
Measured: Immediately after the procedure/surgery
Echocardiographic Assessment: Peak velocity
Peak velocity
Measured: Pre-discharge or at 30 days, 1, 3, 5 years
Echocardiographic Assessment: Mean gradient
Mean gradient
Measured: Pre-discharge or at 30 days, 1, 3, 5 years
Echocardiographic Assessment: Aortic valve area
Aortic valve area
Measured: Pre-discharge or at 30 days, 1, 3, 5 years
Echocardiographic Assessment: Patient-prosthesis mismatch
Patient-prosthesis mismatch
Measured: Pre-discharge or at 30 days
Echocardiographic Assessment: Aortic Regurgitation - paravalvular, transvalvular or total
Aortic Regurgitation - paravalvular, transvalvular or total
Measured: Pre-discharge or at 30 days, 1, 3, 5 years
Echocardiographic Assessment: Left ventricular systolic function
Left ventricular systolic function
Measured: Pre-discharge or at 30 days, 1, 3, 5 years
Clinical Outcomes
All-cause mortality; Cardiovascular mortality; Valve-related mortality; Hospitalisation; Cardiovascular hospitalisation; Hospitalisation for valve or procedure-related causes; All stroke; Myocardial infarction; Coronary angiography; Coronary revascularization; Bioprosthetic valve dysfunction: i. Structural valve deterioration; ii. Non-structural valve deterioration (Prosthesis-patient mismatch, Paravalvular aortic regurgitation, Other) iii. Thrombosis iv. Endocarditis; Bioprosthetic valve failure; Aortic valve re-intervention
Measured: 1, 3 and 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2024
- Study start12 Dec 2024
- Primary completionJun 2027 (estimated)
- Study completionMar 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Aortic Valve StenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 550 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Leeds Teaching Hospitals NHS Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic, NAMSA
- Responsible party
- Sponsor
- Investigators
- Daniel Blackman, MD, Principal investigator, Leeds Teaching Hospitals NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06557798
- Sponsor's protocol ID
- CD23/157535
- Acronym
- REVALVE
- Status last verified
- Oct 2026
- First submitted
- 9 Aug 2024
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 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.
PubMed 30883053Mack 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.
PubMed 30883058Vahanian 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.
PubMed 34453165Otto 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.
PubMed 33332149Fukuhara 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.
PubMed 33284653Bapat 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.
PubMed 34556271Tuzcu 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.
PubMed 30025572Testa 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.
PubMed 34092097Landes 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.
PubMed 33413929Forrestal 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.
PubMed 33272031Ochiai 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.
PubMed 33213747Landes 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.
PubMed 35926921Carroll 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.
PubMed 33213826Blackman 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.
PubMed 40393632