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

Status: Recruiting
Location: See all (21) locations...
Intervention Type: Device, Other, Procedure
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 16
Healthy Volunteers: f
View:

• 1\. Bio-prosthetic Valve Failure (BVF) of a Transcatheter Aortic Valve requiring possible reintervention

Locations
Other Locations
Denmark
Århus Universitetshospital
RECRUITING
Aarhus
Rigshospitalet
RECRUITING
Copenhagen
Finland
HUS Helsinki University Hospital
RECRUITING
Helsinki
Turku University Hospital
RECRUITING
Turku
Netherlands
Maastricht University Medical Center (MUMC)
RECRUITING
Maastricht
Erasmus University Medical Center
RECRUITING
Rotterdam
Norway
Haukeland Sykehus
RECRUITING
Bergen
Oslo University Hospital
RECRUITING
Oslo
Sweden
Sahlgrenska University Hospital
RECRUITING
Gothenburg
Switzerland
Inselspital - Universitätsspital Bern
RECRUITING
Bern
Luzerner Kantonsspital
RECRUITING
Lucerne
United Kingdom
Royal Sussex County Hospital
RECRUITING
Brighton
Bristol Royal Infirmary
RECRUITING
Bristol
University Hospital of Wales
RECRUITING
Cardiff
Golden Jubilee National Hospital
RECRUITING
Glasgow
Leeds Teaching Hospitals NHS Trust
RECRUITING
Leeds
St. George's Hospital
RECRUITING
London
Freeman Hospital
RECRUITING
Newcastle Upon Tyne
Oxford University Hospitals NHS Foundation Trust
RECRUITING
Oxford
University Hospital Southampton NHS Foundation Trust
RECRUITING
Southampton
New Cross Hospital
RECRUITING
Wolverhampton
Contact Information
Primary
Dave Pickles
dave.pickles@nhs.net
+441132433144
Backup
Benaka Karanth
bkaranth@namsa.com
+44 1757 270044
Time Frame
Start Date: 2024-12-12
Estimated Completion Date: 2033-03
Participants
Target number of participants: 550
Treatments
Redo TAVI
Redo Trans-catheter Aortic Valve Implantation for Bioprosthetic Valve Failure of a Trans-catheter Aortic Valve
Explant
Surgical explantation with surgical aortic valve replacement (SAVR)
Optimal Medical Therapy
Conservative treatment, including optimal medical therapy +/- balloon aortic valvuloplasty
Sponsors
Leads: The Leeds Teaching Hospitals NHS Trust
Collaborators: Medtronic, NAMSA

This content was sourced from clinicaltrials.gov