REdo Transcatheter Aortic VALVE Implantation for the Management of Transcatheter Aortic Valve Failure
NCT Number: NCT06557798
Acronym: REVALVE
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Aortic Valve Stenosis
Interventions: DEVICE: Any commercially available transcatheter aortic valve|PROCEDURE: Surgical explantation and aortic valve replacement|OTHER: Conservative management
Sponsor: The Leeds Teaching Hospitals NHS Trust
Collaborators: Medtronic|NAMSA
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 550
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-10
Completion Date: 2033-03

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.

Primary Outcome Measures: 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 Outcome Measures: Valve Academic Research Consortium 3 (VARC3) Technical Success (Redo TAVI and EXPLANT), 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), 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), 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), Invasive pressure measurements, End of procedure|In-hospital Clinical Outcomes, 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: Peak velocity, Peak velocity, Pre-discharge or at 30 days|Echocardiographic Assessment: Mean gradient, Mean gradient, Pre-discharge or at 30 days|Echocardiographic Assessment: Aortic valve area, Aortic valve area, Pre-discharge or at 30 days|Echocardiographic Assessment: Patient-prosthesis mismatch, Patient-prosthesis mismatch, Pre-discharge or at 30 days|Echocardiographic Assessment: Aortic Regurgitation - paravalvular, transvalvular or total, Aortic Regurgitation - paravalvular, transvalvular or total, Pre-discharge or at 30 days|Echocardiographic Assessment: Left ventricular systolic function, Left ventricular systolic function, Pre-discharge or at 30 days|Echocardiographic Assessment: Peak velocity, Peak velocity, 1, 3 and 5 years|Echocardiographic Assessment: Mean gradient, Mean gradient, 1, 3 and 5 years|Echocardiographic Assessment: Aortic valve area, Aortic valve area, 1, 3 and 5 years|Echocardiographic Assessment: Patient-prosthesis mismatch, Patient-prosthesis mismatch, 1, 3 and 5 years|Echocardiographic Assessment: Aortic Regurgitation - paravalvular, transvalvular or total, Aortic Regurgitation - paravalvular, transvalvular or total, 1, 3 and 5 years|Echocardiographic Assessment: Left ventricular systolic function, Left ventricular systolic function, 1, 3 and 5 years|Clinical Outcomes, 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