REdo Transcatheter Aortic VALVE Implantation for the Management of Transcatheter Aortic Valve Failure (REVALVE)

The Leeds Teaching Hospitals NHS Trust

Status: Not yet enrolling

Conditions: Aortic Valve Stenosis

Treatments: Device: Any commercially available transcatheter aortic valve; Procedure: Surgical explantation and aortic valve replacement; Other: Conservative management

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT06557798

CD23/157535

Details and patient eligibility

About

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.

Full 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)

Enrollment: 550 estimated patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

550 participants in 3 patient groups

Redo TAVI

Description:

Redo Trans-catheter Aortic Valve Implantation for Bioprosthetic Valve Failure of a Trans-catheter Aortic Valve

Treatment:

Device: Any commercially available transcatheter aortic valve

Explant

Description:

Surgical explantation with surgical aortic valve replacement (SAVR)

Treatment:

Procedure: Surgical explantation and aortic valve replacement

Optimal Medical Therapy

Description:

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

Treatment:

Other: Conservative management