REdo Transcatheter Aortic VALVE Implantation for the Management of Transcatheter Aortic Valve Failure

The Leeds Teaching Hospitals NHS Trust550 enrolled

Overview

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.

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)

Study Type

OBSERVATIONAL

Enrollment

550

Conditions

Aortic Valve Stenosis

Interventions

Any commercially available Edwards or Medtronic transcatheter aortic valve with the TAV-in-TAV (Redo TAVI) indicationDEVICE

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 replacementPROCEDURE

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 managementOTHER

Conservative treatment, including optimal medical therapy +/- balloon aortic valvuloplasty

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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 6. Pregnant or nursing

Locations (61)

Aalborg Universitethospital

Aalborg, Denmark

RECRUITING

Århus Universitetshospital

Aarhus, Denmark

RECRUITING

Rigshospitalet

Copenhagen, Denmark

RECRUITING

HUS Helsinki University Hospital

Helsinki, Finland

Outcomes

Primary Outcomes

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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 12 months

Secondary Outcomes

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

Time frame: 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)

Time frame: 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

Time frame: 30 days

Peak and mean invasive gradient post-procedure (Redo TAVI)

Invasive pressure measurements

Time frame: 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

Time frame: Immediately after the procedure/surgery

Echocardiographic Assessment: Peak velocity

Peak velocity