NCT Number: NCT06557798
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.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Aalborg Universitethospital, Aalborg, Denmark
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)
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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 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.
Conservative treatment, including optimal medical therapy +/- balloon aortic valvuloplasty
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
Time frame: 12 months
Composite outcome of freedom from death/stroke/re-hospitalisation for valve or procedure-related causes
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
Time frame: 12 months
Composite outcome of freedom from death/stroke/re-hospitalisation for valve or procedure-related causes
Time frame: 12 months
Composite outcome of freedom from death/stroke/re-hospitalisation for valve or procedure-related causes
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
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)
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
Time frame: End of procedure
Invasive pressure measurements
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
Time frame: Pre-discharge or at 30 days, 1, 3, 5 years
Peak velocity
Time frame: Pre-discharge or at 30 days, 1, 3, 5 years
Mean gradient
Time frame: Pre-discharge or at 30 days, 1, 3, 5 years
Aortic valve area
Time frame: Pre-discharge or at 30 days
Patient-prosthesis mismatch
Time frame: Pre-discharge or at 30 days, 1, 3, 5 years
Aortic Regurgitation - paravalvular, transvalvular or total
Time frame: Pre-discharge or at 30 days, 1, 3, 5 years
Left ventricular systolic function
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
Contact information is provided by the study sponsor or research team.
Benaka Karanth
CONTACT
Dave Pickles
CONTACT
The Leeds Teaching Hospitals NHS Trust
Other
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
Acronym: REVALVE
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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