Randomized researcH in womEn all comers wIth Aortic stenosis (v. 1.0)
Research type
Research Study
Full title
A Prospective, Randomized, Controlled, Multi-Center Study to Evaluate the Safety and Efficacy of Transcatheter Aortic Valve Implantation in Female Patients who have Severe Symptomatic Aortic Stenosis Requiring Aortic Valve Replacement
IRAS ID
273757
Contact name
Nicholas Cruden
Contact email
Sponsor organisation
SSS International Clinical Research GmbH
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 1 months, 30 days
Research summary
The prospective, randomised clinical investigation called 'RHEIA: Randomized research in women all comers with aortic stenosis' is investigating female patients with severe symptomatic aortic stenosis requiring an aortic valve replacement only. Aortic stenosis (AS) is one of the most common valvular diseases in developed countries, affecting ~5% of adults above the age of 65, and its prevalence is projected to increase over the next decade with an aging population. Recent large meta-analyses and a large retrospective study demonstrated improved survival in female versus male AS patients undergoing TAVI despite their advanced age and increased rates of major peri-procedural vascular complications, bleeding events and strokes. The purpose of this study is to evaluate the safety and efficacy of Transcatheter Aortic Valve Implantation (TAVI) as compared to Surgical Aortic Valve Replacement (SAVR) in female patients with severe symptomatic aortic stenosis. Taken all available scientific data on the comparison of TAVI versus open surgery in patients with indication for AVR together it remains probable, that independently of the individual surgical risk female patients in particular seem to benefit from a non-surgical aortic valve replacement strategy.
This study is a multi-centre study involving hospitals (secondary care) as study sites in the UK and in other (non-)EU member states. Used study devices are CE marked Edwards SAPIEN 3 THV system Model 9600 TFX (20, 23, 26 and 29 mm) or SAPIEN 3 Ultra THV system Model 9750 TFX (20, 23, 26 mm) with Edwards Commander Delivery System. Commercially available surgical bio-prosthetic aortic valves (according to clinical standard) are used as control. Only patients suitable for TAVI and SAVR are eligible and will be randomised to one of the both treatment arms. Eligibility will be reviewed by a screening review board prior to randomisation. Patients will participate in the study up to 14 months a maximum post consent.The lay summary will be uploaded to the clinicaltrials.gov RHEIA study entry soon.
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REC name
London - Bloomsbury Research Ethics Committee
REC reference
20/LO/0278
Date of REC Opinion
18 May 2020
REC opinion
Further Information Favourable Opinion