Hydra Registry - UK
Recruiting now
Conditions studied: Aortic Valve Stenosis
In brief
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.
Key facts
- Study ID
- NCT06507579
- Run by
- Sahajanand Medical Technologies Limited
- People needed
- 250
- Starts
- 2024-07-11
- Expected to finish
- 2026-08-01
- Last updated by the study team
- 2026-04-27
Who can join
Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Patients with severe aortic stenosis eligible for transfemoral TAVI procedure as per local Heart Team evaluation
- Full understanding and willing to provide informed consent to study enrolment
- Age ≥ 18 years
You may not qualify if…
- Contraindications to TAVI (e.g., anatomically phenotypes, intracardiac mass, thrombus, vegetation, endocarditis)
- Refusal to provide informed consent to study enrolment
- Patients with severe aorta or peripheral artery disease precluding transfemoral approach of TAVI
- Patients with significant calcification of the aortic annulus and in the Left Ventricular Outflow Tract (LVOT), or/and excess calcium within each cusp, or those who are deemed unsuitable for the Hydra THV series based on the clinical judgment of the Investigator.
Where it is running
- Northern General Hospital, Sheffield Teaching Hospitals NHS Foundation Trust — Sheffield, Yorkshire, United Kingdom (enrolling)
- Castle Hill Hull — Cottingham, United Kingdom (enrolling)
- Royal Victoria Hospital — Belfast, United Kingdom
- Royal Papworth — Cambridge, United Kingdom
Full record on ClinicalTrials.gov
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