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

NCT06557798 | Recruiting DMC

• 1 other identifier: CD23/157535
• Study Type: observational
• Target: 550
• Locations: 11 countries
• Sites: 53

Brief 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. 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.

Conditions

Aortic Valve Stenosis

Keywords

Bioprosthetic Valve Failure

Outcome Measures

Primary Outcomes (5)

• 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

  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

  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

  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

  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

  12 months

Secondary Outcomes (12)

• Valve Academic Research Consortium 3 (VARC3) Technical Success (Redo TAVI and EXPLANT)

  End of procedure

• Valve Academic Research Consortium 3 (VARC3) Device Success (Redo TAVI and EXPLANT)

  30 days

• Valve Academic Research Consortium 3 (VARC3) Early Safety (Redo TAVI)

  30 days

• Peak and mean invasive gradient post-procedure (Redo TAVI)

  End of procedure

• In-hospital Clinical Outcomes

  Immediately after the procedure/surgery

Study Arms (3)

Redo TAVI

Redo Trans-catheter Aortic Valve Implantation for Bioprosthetic Valve Failure of a Trans-catheter Aortic Valve

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

Procedure: Surgical explantation and aortic valve replacement

Optimal Medical Therapy

Conservative treatment, including optimal medical therapy +/- balloon aortic valvuloplasty

Other: Conservative management

Interventions

Surgical explantation and aortic valve replacement PROCEDURE

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.

Explant

Any commercially available Edwards or Medtronic transcatheter aortic valve with the TAV-in-TAV (Redo TAVI) indication DEVICE

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.

Redo TAVI

Conservative management OTHER

Conservative treatment, including optimal medical therapy +/- balloon aortic valvuloplasty

Optimal Medical Therapy

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

All patients presenting to the Heart Team with bio-prosthetic valve failure affecting a transcatheter aortic valve

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Leeds Teaching Hospitals NHS Trust: lead
• Medtronic: collaborator
• NAMSA: collaborator

Study Sites (53)

Aalborg Universitethospital

Aalborg, Denmark

RECRUITING

Århus Universitetshospital

Aarhus, Denmark

RECRUITING

Rigshospitalet

Copenhagen, Denmark

RECRUITING

HUS Helsinki University Hospital

Helsinki, Finland

RECRUITING

Turku University Hospital

Turku, Finland

RECRUITING

Clinical Saint Augustin - Elsan

Bordeaux, France

RECRUITING

Brest University Hospital Centre

Brest, France

RECRUITING

Henri Mondor University Hospital

Créteil, France

RECRUITING

ICPS Hôpital privé Jacques-Cartier

Massy, France

RECRUITING

Hospital Marie Lannelongue

Paris, France

RECRUITING

Institute Mutualiste Montsouris

Paris, France

RECRUITING

Les Hospital Universitaires de Strasbourg

Strasbourg, France

RECRUITING

Clinique Pasteur Toulouse

Toulouse, France

RECRUITING

CHRU Hospitals of Tours

Tours, France

RECRUITING

Medipole Lyon-Villeurbanne

Villeurbanne, France

RECRUITING

Kerckhoff Klinik

Bad Nauheim, Germany

RECRUITING

Herz- und Diabeteszentrum NRW

Bad Oeynhausen, Germany

RECRUITING

Klinikum Dortmund GmbH - St. Johannes Hospital

Dortmund, Germany

RECRUITING

Herzzentrum Dresden Universitätsklinik

Dresden, Germany

RECRUITING

Universitatsklinikum Frankfurt

Frankfurt, Germany

RECRUITING

Universitätsklinikum Schleswig-Holstein (UKSH)

Kiel, Germany

RECRUITING

HELIOS Herzzentrum Leipzig GmbH

Leipzig, Germany

RECRUITING

Universitätsklinikum Schleswig-Holstein (UKSH)

Lübeck, Germany

RECRUITING

LMU Klinikum

München, Germany

RECRUITING

Shaare Zedek Medical Center

Jerusalem, Israel

RECRUITING

Azienda Ospedaliero Universitaria Policlinico Vittorio Emanuele

Catania, Italy

RECRUITING

Centro Cardiologico Monzino

Milan, Italy

RECRUITING

IRCSS Policlinico San Donato

San Donato Milanese, Italy

RECRUITING

Ospedale Borgo Trento - Azienda Ospedaliera Universitaria Integrata Verona

Verona, Italy

RECRUITING

Amphia Hospital

Breda, Netherlands

RECRUITING

Maastricht University Medical Center (MUMC)

Maastricht, Netherlands

RECRUITING

Erasmus University Medical Center

Rotterdam, Netherlands

RECRUITING

Haukeland Sykehus

Bergen, Norway

RECRUITING

Oslo University Hospital

Oslo, Norway

RECRUITING

Sahlgrenska University Hospital

Gothenburg, Sweden

RECRUITING

Skånes Universitetssjukhus Lund

Lund, Sweden

RECRUITING

Nya Karolinska Sjukhuset Solna

Solna, Sweden

RECRUITING

Inselspital - Universitätsspital Bern

Bern, Switzerland

RECRUITING

Luzerner Kantonsspital

Lucerne, Switzerland

RECRUITING

Queen Elizabeth Hospital

Birmingham, United Kingdom

RECRUITING

Royal Sussex County Hospital

Brighton, BN2 1ES, United Kingdom

RECRUITING

Bristol Royal Infirmary

Bristol, United Kingdom

RECRUITING

University Hospital of Wales

Cardiff, CF14 4XW, United Kingdom

RECRUITING

Golden Jubilee National Hospital

Glasgow, United Kingdom

RECRUITING

Leeds Teaching Hospitals NHS Trust

Leeds, LS1 3EX, United Kingdom

RECRUITING

Glenfield Hospital

Leicester, United Kingdom

RECRUITING

Guys and St Thomas' NHS Foundation Trust

London, United Kingdom

RECRUITING

St. George's Hospital

London, United Kingdom

RECRUITING

Manchester Royal Infirmary

Manchester, United Kingdom

RECRUITING

Freeman Hospital

Newcastle upon Tyne, United Kingdom

RECRUITING

Oxford University Hospitals NHS Foundation Trust

Oxford, OX3 9DU, United Kingdom

RECRUITING

University Hospital Southampton NHS Foundation Trust

Southampton, SO16 6YD, United Kingdom

RECRUITING

New Cross Hospital

Wolverhampton, United Kingdom

RECRUITING

Related Publications (14)

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• 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.

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  PMID: 40393632 DERIVED

MeSH Terms

Conditions

Aortic Valve Stenosis

Interventions

Conservative Treatment

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Daniel Blackman, MD

  Leeds Teaching Hospitals NHS Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dave Pickles

CONTACT

+441132433144; dave.pickles@nhs.net

Benaka Karanth

CONTACT

+44 1757 270044; bkaranth@namsa.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2024
• First Posted: August 16, 2024
• Study Start: December 12, 2024
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): March 1, 2033
• Last Updated: February 3, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

FI (2); DE (9); IL (1); IT (4); GB (14); FR (10); DK (3); NL (3); NO (2); SE (3); CH (2)