Actively Recruiting
Hydra Registry - UK
Led by Sahajanand Medical Technologies Limited · Updated on 2026-04-27
250
Participants Needed
4
Research Sites
107 weeks
Total Duration
On this page
Sponsors
S
Sahajanand Medical Technologies Limited
Lead Sponsor
P
Psephos Biomedica
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Hydra Registry - UK
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with severe aortic stenosis eligible for transfemoral TAVI procedure as per local Heart Team evaluation
- Able to fully understand and willing to provide informed consent to study enrollment
- Age 18 years or older
You will not qualify if you...
- Contraindications to TAVI such as anatomical phenotypes, intracardiac mass, thrombus, vegetation, or endocarditis
- Refusal to provide informed consent to study enrollment
- Severe aorta or peripheral artery disease precluding transfemoral TAVI approach
- Significant calcification of the aortic annulus, left ventricular outflow tract, or excess calcium in each cusp, or deemed unsuitable for Hydra THV based on investigator judgment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
Northern General Hospital, Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield, Yorkshire, United Kingdom, S5 7AU
Actively Recruiting
2
Royal Victoria Hospital
Belfast, United Kingdom, BT12 6BA
Not Yet Recruiting
3
Royal Papworth
Cambridge, United Kingdom, CB2 0AY
Not Yet Recruiting
4
Castle Hill Hull
Cottingham, United Kingdom, HU16 5JQ
Actively Recruiting
Research Team
D
Dr. Javaid Iqbal, MRCP, PhD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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