HYDRA Registry- HYD/SHEFFIELD-001/2023
Research type
Research Study
Full title
Prospective Observational Study on the Efficacy and Safety of Hydra Transcatheter Aortic Valve.
IRAS ID
331199
Contact name
Javaid Iqbal
Contact email
Sponsor organisation
Sahajanand Medical Technologies
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 0 months, 1 days
Research summary
This Prospective, observational, multi-centre study, aims to evaluate the efficacy and safety of TAVI (Transcatheter Aortic Valve Implantation) using the CE marked Hydra THV (Transcatheter Heart Valve) series, in patients with severe aortic stenosis who have been identified to receive the Hydra THV series as part of their routine care, for up to 1 year after the procedure. This will also include an evaluation of the preservation of coronary access post implant in a sub-set of patients by attempting to selectively engage both the right and left coronary arteries through standardised angiographic views. The study will also examine the utility of 72 hours of post discharge remote ambulatory continuous ECG monitoring using the novel Checkpoint Cardio System.
250 patients will be enrolled in total in up to 10 sites, with the aim of the study being to collect clinical, procedural, and follow-up data, in order to evaluate the performance of the Hydra THV series.
Aortic valve stenosis is the most common valve disease in older patients, showing an increasing prevalence due to an ageing population. 3.4% of western world population older than 75 years is affected by severe aortic stenosis. Symptoms onset (shortness of breath, angina, syncope) dramatically change the natural history of aortic stenosis with a 50% mortality after 2 years.
For several decades, the optimum treatment for patients with severe symptomatic aortic stenosis has been Surgical Aortic Valve Replacements (SAVR), whereas medical therapy alone does not improve the prognosis. TAVI is a new (approved in Europe in 2007) and less invasive treatment, and has become an alternative to SAVR for elderly patients with severe symptomatic aortic stenosis.Controlled randomised trials have demonstrated that TAVI is superior to medical treatment in patient’s ineligible for SAVR, and not inferior compared to SAVR in patients at high, intermediate, or low surgical risk.
REC name
Yorkshire & The Humber - Leeds West Research Ethics Committee
REC reference
24/YH/0064
Date of REC Opinion
16 Apr 2024
REC opinion
Further Information Favourable Opinion