ALL WOMEN version 2.0, dated 29 January 2024
Research type
Research Study
Full title
A multicenter randomized clinical trial comparing self-expanding ALLEGRA Valve to any other balloon-expandable valve in a Women population
IRAS ID
333855
Contact name
Ghada W. I. Mikhail
Contact email
Sponsor organisation
Center for European Research Initiatives in Cardiovascular Medicine (CERIC)
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 11 months, 31 days
Research summary
Degenerative aortic valve stenosis (AS) is one of the most common acquired valvular diseases in adults in Western countries. Prevalence of AS is continuously growing as average age of the population increases. Once symptoms occur, the prognosis is very poor; the mean survival in patients with severe, untreated symptomatic aortic stenosis is approximately 2-3 years. Medical therapy can only delay, but not reverse or stop the progress of AS. The only available treatment options for these patients are surgical or transcatheter aortic valve replacement (SAVR or TAVR).
TAVR involves an aortic valve implantation without open heart surgery and does not require removal of the failed native aortic valve that is causing the problems. Nowadays TAVR has been developed as a standardized interventional procedure with a predictable risk.
Women represent less than 50% of patients undergoing TAVR. Women and men undergoing TAVR have distinct baseline characteristics, which may have a differential impact on post-TAVR and long-term events.
All Women is an investigator-initiated, multicenter, randomized, post-market superiority study which will recruit up to 130 female patients aged ≥75 years with symptomatic severe aortic stenosis in around 13 hospitals in European countries. It aims to test that in this patient population the CE-marked self-expandable ALLEGRA Transcatheter Aortic Valve system (NVT, Morges, Switzerland) performs better than CE-marked balloon-expandable valves.
Patients will be randomized (1:1) to treatment by the ALLEGRA Transcatheter Aortic Valve or any CE-marked transfemoral balloon expandable valve system. After implantation of a bioprosthesis, patients will be involved in the study for one year with follow-up in the hospital according to current practise at 30 days and 12 months. Implantation of the device and FU will follow the standard of care at the respective hospitals.REC name
London - Dulwich Research Ethics Committee
REC reference
24/LO/0240
Date of REC Opinion
24 Jun 2024
REC opinion
Further Information Favourable Opinion