At a glance
- What the study gets you
- Health checks and monitoring — no treatment given
- Type of study
- Observational (no treatment given)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Any commercially available Edwards or Medtronic transcatheter aortic valve with the TAV-in-TAV (Redo TAVI) indication (device), Surgical explantation and aortic valve replacement (procedure), Conservative management (other)
- How long the study runs
- Study runs about 99 months (dates as stated)
- About the drug or intervention
- 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. · 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. · Conservative management — other: Conservative treatment, including optimal medical therapy +/- balloon aortic valvuloplasty
- Patient visit burden
- Not specified by the sponsor
In plain English
This study, run by The Leeds Teaching Hospitals NHS Trust, looks at people whose transcatheter aortic valve (a replacement heart valve put in through a tube in a blood vessel) has stopped working properly. The condition being studied is aortic valve stenosis, where the heart's aortic valve becomes narrowed. The study explores doing a second valve procedure to manage this valve failure.
Who can take part
- People whose transcatheter aortic valve (a replacement heart valve fitted through a blood vessel) has failed and who may need another procedure.
Who may not be able to
- Valve failure caused only by paravalvular aortic regurgitation (leaking around the edge of the valve).
- An active infection of the heart valve (endocarditis).
- A sudden blood clot on the valve that has not been treated.
- A life expectancy of less than one year.
- People under the legal age of consent, people unable to consent for themselves, or others considered vulnerable.
- People who are pregnant or breastfeeding.
What taking part involves
- • Not stated — ask the trial team.
Time commitment: Not stated — ask the trial team about visits, duration, and what taking part involves.
Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.
- Type of study
- Observing health over time
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 550
- Started
- 2024-12-12
- Last checked
- 2026-06
Plain English Summary
What is this study?
- • Testing a new treatment for aortic valve stenosis
- • Clinical study - 550 participants
- • Transcatheter aortic valve implantation (TAVI) is a key-hole technique to replace an aortic heart valve that is narrowed and/or leaking
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with aortic valve stenosis
Where?
- • Birmingham - Queen Elizabeth Hospital
- • Brighton - Royal Sussex County Hospital
- • Bristol - Bristol Royal Infirmary
- • Cardiff - University Hospital of Wales
- • +10 more UK sites
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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.
More detail
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)
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
What the study is looking for
- ✓1\. Bio-prosthetic Valve Failure (BVF) of a Transcatheter Aortic Valve requiring possible reintervention
Who cannot take part
- ✗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
See the full criteria
Where Is This Study? (14 UK sites)
Queen Elizabeth Hospital
Birmingham, United Kingdom
Royal Sussex County Hospital
Brighton BN2 1ES, United Kingdom
Bristol Royal Infirmary
Bristol, United Kingdom
University Hospital of Wales
Cardiff CF14 4XW, United Kingdom
Golden Jubilee National Hospital
Glasgow, United Kingdom
Leeds Teaching Hospitals NHS Trust
Leeds LS1 3EX, 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 OX3 9DU, United Kingdom
University Hospital Southampton NHS Foundation Trust
Southampton SO16 6YD, United Kingdom
New Cross Hospital
Wolverhampton, United Kingdom
How to Get in Touch
Dave Pickles
Sponsor contactCONTACT
Benaka Karanth
Sponsor contactCONTACT