REdo Transcatheter Aortic VALVE Implantation for the Management of Transcatheter Aortic Valve Failure
- Conditions
- Aortic Valve Stenosis
- Interventions
- Device: Any commercially available transcatheter aortic valveProcedure: Surgical explantation and aortic valve replacementOther: Conservative management
- Registration Number
- NCT06557798
- Lead Sponsor
- The Leeds Teaching Hospitals NHS Trust
- 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)
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 550
- Bio-prosthetic Valve Failure (BVF) of a Transcatheter Aortic Valve requiring possible reintervention
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Redo TAVI Any commercially available transcatheter aortic valve Redo Trans-catheter Aortic Valve Implantation for Bioprosthetic Valve Failure of a Trans-catheter Aortic Valve Explant Surgical explantation and aortic valve replacement Surgical explantation with surgical aortic valve replacement (SAVR) Optimal Medical Therapy Conservative management Conservative treatment, including optimal medical therapy +/- balloon aortic valvuloplasty
- Primary Outcome Measures
Name Time Method Freedom from death/stroke/re-hospitalisation for valve or procedure-related causes (EXPLANT) 12 months Composite outcome of freedom from death/stroke/re-hospitalisation for valve or procedure-related causes
REVALVE success (Redo TAVI) 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
Freedom from death/stroke/re-hospitalisation for valve or procedure-related causes (Redo TAVI) 12 months Composite outcome of freedom from death/stroke/re-hospitalisation for valve or procedure-related causes
Valve Academic Research Consortium 3 (VARC3) Early Safety (EXPLANT) 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
Freedom from death/stroke/re-hospitalisation for valve or procedure-related causes (OMT) 12 months Composite outcome of freedom from death/stroke/re-hospitalisation for valve or procedure-related causes
- Secondary Outcome Measures
Name Time Method Valve Academic Research Consortium 3 (VARC3) Technical Success (Redo TAVI and EXPLANT) 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
Valve Academic Research Consortium 3 (VARC3) Early Safety (Redo TAVI) 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
Echocardiographic Assessment: Mean gradient 1, 3 and 5 years Mean gradient
Echocardiographic Assessment: Patient-prosthesis mismatch 1, 3 and 5 years Patient-prosthesis mismatch
Clinical Outcomes 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
Valve Academic Research Consortium 3 (VARC3) Device Success (Redo TAVI and EXPLANT) 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)
Echocardiographic Assessment: Peak velocity 1, 3 and 5 years Peak velocity
Peak and mean invasive gradient post-procedure (Redo TAVI) End of procedure Invasive pressure measurements
In-hospital Clinical Outcomes 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
Echocardiographic Assessment: Aortic valve area 1, 3 and 5 years Aortic valve area
Echocardiographic Assessment: Aortic Regurgitation - paravalvular, transvalvular or total 1, 3 and 5 years Aortic Regurgitation - paravalvular, transvalvular or total
Echocardiographic Assessment: Left ventricular systolic function 1, 3 and 5 years Left ventricular systolic function
Trial Locations
- Locations (8)
Rigshospitalet
🇩🇰Copenhagen, Denmark
Århus Universitetshospital
🇩🇰Århus, Denmark
University Hospital Southampton NHS Foundation Trust
🇬🇧Southampton, United Kingdom
Oslo University Hospital
🇳🇴Oslo, Norway
Royal Sussex County Hospital
🇬🇧Brighton, United Kingdom
University Hospital of Wales
🇬🇧Cardiff, United Kingdom
Leeds Teaching Hospitals NHS Trust
🇬🇧Leeds, United Kingdom
Oxford University Hospitals NHS Foundation Trust
🇬🇧Oxford, United Kingdom