Clinical trial NCT06557798: 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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Aortic Valve Stenosis
Keywords: Bioprosthetic Valve Failure
Lead sponsor: The Leeds Teaching Hospitals NHS Trust
Sponsor class: OTHER
Collaborators: name: Medtronic
name: NAMSA
First posted: 2024-08-16
Enrollment: 550
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients presenting to the Heart Team with bio-prosthetic valve failure affecting a transcatheter aortic valve

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.

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 surgical aortic valve replacement (SAVR) 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)

Eligibility criteria: 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.

Primary outcomes:
measure: REVALVE success (Redo TAVI)
timeFrame: 30 days
measure: Freedom from death/stroke/re-hospitalisation for valve or procedure-related causes (Redo TAVI)
timeFrame: 12 months
measure: Valve Academic Research Consortium 3 (VARC3) Early Safety (EXPLANT)
timeFrame: 30 days
measure: Freedom from death/stroke/re-hospitalisation for valve or procedure-related causes (EXPLANT)
timeFrame: 12 months
measure: Freedom from death/stroke/re-hospitalisation for valve or procedure-related causes (OMT)
timeFrame: 12 months
Secondary outcomes:
measure: Valve Academic Research Consortium 3 (VARC3) Technical Success (Redo TAVI and EXPLANT)
timeFrame: End of procedure
measure: Valve Academic Research Consortium 3 (VARC3) Device Success (Redo TAVI and EXPLANT)
timeFrame: 30 days
measure: Valve Academic Research Consortium 3 (VARC3) Early Safety (Redo TAVI)
timeFrame: 30 days
measure: Peak and mean invasive gradient post-procedure (Redo TAVI)
timeFrame: End of procedure
measure: In-hospital Clinical Outcomes
timeFrame: Immediately after the procedure/surgery
measure: Echocardiographic Assessment: Peak velocity
timeFrame: Pre-discharge or at 30 days
measure: Echocardiographic Assessment: Mean gradient
timeFrame: Pre-discharge or at 30 days
measure: Echocardiographic Assessment: Aortic valve area
timeFrame: Pre-discharge or at 30 days
measure: Echocardiographic Assessment: Patient-prosthesis mismatch
timeFrame: Pre-discharge or at 30 days
measure: Echocardiographic Assessment: Aortic Regurgitation - paravalvular, transvalvular or total
timeFrame: Pre-discharge or at 30 days
measure: Echocardiographic Assessment: Left ventricular systolic function
timeFrame: Pre-discharge or at 30 days
measure: Echocardiographic Assessment: Peak velocity
timeFrame: 1, 3 and 5 years
measure: Echocardiographic Assessment: Mean gradient
timeFrame: 1, 3 and 5 years
measure: Echocardiographic Assessment: Aortic valve area
timeFrame: 1, 3 and 5 years
measure: Echocardiographic Assessment: Patient-prosthesis mismatch
timeFrame: 1, 3 and 5 years
measure: Echocardiographic Assessment: Aortic Regurgitation - paravalvular, transvalvular or total
timeFrame: 1, 3 and 5 years
measure: Echocardiographic Assessment: Left ventricular systolic function
timeFrame: 1, 3 and 5 years
measure: Clinical Outcomes
timeFrame: 1, 3 and 5 years
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Rigshospitalet
city: Århus
country: Denmark
facility: Århus Universitetshospital
city: Oslo
country: Norway
facility: Oslo University Hospital
city: Brighton
country: United Kingdom
facility: Royal Sussex County Hospital
city: Cardiff
country: United Kingdom
facility: University Hospital of Wales
city: Leeds
country: United Kingdom
facility: Leeds Teaching Hospitals NHS Trust
city: Oxford
country: United Kingdom
facility: Oxford University Hospitals NHS Foundation Trust
city: Southampton
country: United Kingdom
facility: University Hospital Southampton NHS Foundation Trust
Study officials:
affiliation: Leeds Teaching Hospitals NHS Trust
name: Daniel Blackman, MD
role: PRINCIPAL_INVESTIGATOR
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