Hydra Registry - UK
ConditionAortic Valve Stenosis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-99
SponsorSahajanand Medical Technologies Limited
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Hydra transcatheter aortic valve (THV) series
Treatment groups
250 Participants
are divided into 1 treatment groupLocations
4Northern General Hospital, Sheffield Teaching Hospitals NHS Foundation TrustS5 7AU, SheffieldYorkshire, United Kingdom
Royal Victoria HospitalBT12 6BA, Belfast United Kingdom
Royal PapworthCB2 0AY, Cambridge United Kingdom
Castle Hill HullHU16 5JQ, Cottingham United Kingdom
Sponsors and collaborators
Sahajanand Medical Technologies Limited
Lead sponsor
Psephos Biomedica
Collaborator
Source ClinicalTrials.gov