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Hydra Registry - UK
Sponsor: Sahajanand Medical Technologies Limited
Summary
The study will evaluate the efficacy and safety of transcatheter aortic valve implantation (TAVI) using the Hydra transcatheter aortic heart valve (THV) series, in patients with severe aortic stenosis up to 1-year after the procedure. This will include an evaluation of the preservation of coronary access post implant 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 electrocardiogram (ECG) monitoring using the novel Checkpoint Cardio System where it is clinically appropriate.
Official title: Prospective Observational Study on the Efficacy and Safety of Hydra Transcatheter Aortic Valve
Key Details
Gender
All
Age Range
18 Years - 99 Years
Study Type
OBSERVATIONAL
Enrollment
250
Start Date
2024-07-11
Completion Date
2026-08-01
Last Updated
2025-02-19
Healthy Volunteers
No
Conditions
Interventions
Hydra transcatheter aortic valve (THV) series
The Hydra device consists of a self-expanding nitinol frame and three bovine pericardial leaflets in supra-annular position.
Locations (4)
Northern General Hospital, Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield, Yorkshire, United Kingdom
Royal Victoria Hospital
Belfast, United Kingdom
Royal Papworth
Cambridge, United Kingdom
Castle Hill Hull
Cottingham, United Kingdom