REdo Transcatheter Aortic VALVE Implantation for the Management of Transcatheter Aortic Valve Failure (REVALVE)

May 8, 2026 updated by: The Leeds Teaching Hospitals NHS Trust

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.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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)

Study Type

Observational

Enrollment (Estimated)

550

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Denmark
      • Aalborg, Denmark
        • Recruiting
        • Aalborg Universitethospital
      • Aarhus, Denmark
        • Recruiting
        • Århus Universitetshospital
      • Copenhagen, Denmark
        • Recruiting
        • Rigshospitalet
  • Finland
      • Helsinki, Finland
        • Recruiting
        • HUS Helsinki University Hospital
      • Turku, Finland
        • Recruiting
        • Turku University Hospital
  • France
      • Bordeaux, France
        • Recruiting
        • Clinical Saint Augustin - Elsan
      • Brest, France
        • Recruiting
        • Brest University Hospital Centre
      • Créteil, France
        • Recruiting
        • Henri Mondor University Hospital
      • Massy, France
        • Recruiting
        • ICPS Hôpital privé Jacques-Cartier
      • Montpellier, France
        • Recruiting
        • Centre Hospitalier Universitaire de Montpellier
      • Nîmes, France
        • Recruiting
        • University Hospital of Nîmes
      • Paris, France
        • Recruiting
        • Institute Mutualiste Montsouris
      • Paris, France
        • Recruiting
        • Hospital Marie Lannelongue
      • Strasbourg, France
        • Recruiting
        • Les Hospital Universitaires de Strasbourg
      • Toulouse, France
        • Recruiting
        • Clinique Pasteur Toulouse
      • Tours, France
        • Recruiting
        • CHRU Hospitals of Tours
      • Villeurbanne, France
        • Recruiting
        • Medipole Lyon-Villeurbanne
  • Germany
      • Bad Nauheim, Germany
        • Recruiting
        • Kerckhoff Klinik
      • Bad Oeynhausen, Germany
        • Recruiting
        • Herz- und Diabeteszentrum NRW
      • Berlin, Germany
        • Withdrawn
        • Deutsches Herzzentrum Berlin
      • Cologne, Germany
        • Recruiting
        • Universitätsklinikum Köln (AöR)
      • Dortmund, Germany
        • Recruiting
        • Klinikum Dortmund GmbH - St. Johannes Hospital
      • Dresden, Germany
        • Recruiting
        • Herzzentrum Dresden Universitätsklinik
      • Düsseldorf, Germany
        • Recruiting
        • Universitatsklinikum Dusseldorf (University Hospital Dusseldorf)
      • Frankfurt, Germany
        • Recruiting
        • Universitatsklinikum Frankfurt
      • Hamburg, Germany
        • Recruiting
        • Asklepios Klinik St. Georg
      • Kiel, Germany
        • Recruiting
        • Universitätsklinikum Schleswig-Holstein (UKSH)
      • Leipzig, Germany
        • Recruiting
        • Helios Herzzentrum Leipzig GmbH
      • Lübeck, Germany
        • Recruiting
        • Universitätsklinikum Schleswig-Holstein (UKSH)
      • München, Germany
        • Recruiting
        • LMU Klinikum
      • Ulm, Germany
        • Recruiting
        • Universitatsklinikum Ulm (University Hospital Ulm)
  • Israel
      • Holon, Israel
        • Recruiting
        • Edith Wolfson Medical Center
      • Jerusalem, Israel
        • Recruiting
        • Shaare Zedek Medical Center
      • Petah Tikva, Israel
        • Recruiting
        • Rabin Medical Center - Belinson Campus
  • Italy
      • Brescia, Italy
        • Recruiting
        • ASST Spedali Civili di Brescia
      • Brescia, Italy
        • Recruiting
        • Fondazione Poliambulanza Istituto Ospedaliero
      • Catania, Italy
        • Recruiting
        • Azienda Ospedaliero Universitaria Policlinico Vittorio Emanuele
      • Genova, Italy
        • Recruiting
        • Ospedale San Martino - IRCCS Ospedale Policlinico
      • Milan, Italy
        • Recruiting
        • IRCCS Ospedale San Raffaele
      • Milan, Italy
        • Recruiting
        • Centro Cardiologico Monzino
      • Milan, Italy
        • Withdrawn
        • Humanitas Research Hospital - RCCS Istituto Clinico Humanitas di Milano
      • San Donato Milanese, Italy
        • Recruiting
        • IRCSS Policlinico San Donato
      • Torino, Italy
        • Recruiting
        • Azienda Ospedaliera Ordine Mauriziano di Torino
      • Verona, Italy
        • Recruiting
        • Ospedale Borgo Trento - Azienda Ospedaliera Universitaria Integrata Verona
  • Netherlands
      • Breda, Netherlands
        • Recruiting
        • Amphia Hospital
      • Maastricht, Netherlands
        • Recruiting
        • Maastricht University Medical Center (MUMC)
      • Nijmegen, Netherlands
        • Withdrawn
        • Radboud Universitair Medisch Centrum
      • Rotterdam, Netherlands
        • Recruiting
        • Erasmus University Medical Center
  • Norway
      • Bergen, Norway
        • Recruiting
        • Haukeland Sykehus
      • Oslo, Norway
        • Recruiting
        • Oslo University Hospital
        • Contact:
          • Principal Investigator
          • Phone Number: +441132432799
          • Email: revalve@nhs.net
  • Sweden
      • Gothenburg, Sweden
        • Recruiting
        • Sahlgrenska University Hospital
      • Lund, Sweden
        • Recruiting
        • Skånes Universitetssjukhus Lund
      • Solna, Sweden
        • Recruiting
        • Nya Karolinska Sjukhuset Solna
  • Switzerland
      • Bern, Switzerland
        • Recruiting
        • Inselspital - Universitätsspital Bern
      • Lucerne, Switzerland
        • Recruiting
        • Luzerner Kantonsspital
  • United Kingdom
      • Birmingham, United Kingdom
        • Recruiting
        • Queen Elizabeth Hospital
      • Brighton, United Kingdom, BN2 1ES
        • Recruiting
        • Royal Sussex County Hospital
      • Bristol, United Kingdom
        • Recruiting
        • Bristol Royal Infirmary
      • Cardiff, United Kingdom, CF14 4XW
        • Recruiting
        • University Hospital of Wales
        • Contact:
          • Principal Investigator
          • Phone Number: +441132432799
          • Email: revalve@nhs.net
      • Glasgow, United Kingdom
        • Recruiting
        • Golden Jubilee National Hospital
      • Leeds, United Kingdom, LS1 3EX
        • Recruiting
        • Leeds Teaching Hospitals NHS Trust
        • Contact:
      • Leicester, United Kingdom
        • Recruiting
        • Glenfield Hospital
      • London, United Kingdom
        • Recruiting
        • Guys and St Thomas' NHS Foundation Trust
      • London, United Kingdom
        • Recruiting
        • St. George's Hospital
      • Manchester, United Kingdom
        • Recruiting
        • Manchester Royal Infirmary
      • Newcastle upon Tyne, United Kingdom
        • Recruiting
        • Freeman Hospital
      • Oxford, United Kingdom, OX3 9DU
        • Recruiting
        • Oxford University Hospitals NHS Foundation Trust
      • Southampton, United Kingdom, SO16 6YD
        • Recruiting
        • University Hospital Southampton NHS Foundation Trust
      • Wolverhampton, United Kingdom
        • Recruiting
        • New Cross Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

  1. Bio-prosthetic Valve Failure due solely to paravalvular aortic regurgitation
  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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
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.
Optimal Medical Therapy
Conservative treatment, including optimal medical therapy +/- balloon aortic valvuloplasty
Other: Conservative management
Conservative treatment, including optimal medical therapy +/- balloon aortic valvuloplasty
Explant
Surgical explantation with aortic valve replacement
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 discretion of the local team.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
REVALVE success (Redo TAVI)
Time Frame: 30 days
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)
Time Frame: 12 months
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)
Time Frame: 30 days
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)
Time Frame: 12 months
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)
Time Frame: 12 months
Composite outcome of freedom from death/stroke/re-hospitalisation for valve or procedure-related causes
12 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Leeds Teaching Hospitals NHS Trust

Collaborators

Medtronic
NAMSA

Investigators

  • Principal Investigator: Daniel Blackman, MD, Leeds Teaching Hospitals NHS Trust

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 12, 2024

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

March 1, 2033

Study Registration Dates

First Submitted

August 9, 2024

First Submitted That Met QC Criteria

August 13, 2024

First Posted (Actual)

August 16, 2024

Study Record Updates

Last Update Posted (Actual)

May 13, 2026

Last Update Submitted That Met QC Criteria

May 8, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CD23/157535

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Aortic Valve Stenosis

Clinical Trials on Conservative management

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Ireland

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe