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.
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
99 Years
Healthy volunteers
No
Inclusion Criteria:
1. Patients with severe aortic stenosis eligible for transfemoral TAVI procedure as per local Heart Team evaluation
2. Full understanding and willing to provide informed consent to study enrolment
3. Age ≥ 18 years
Exclusion Criteria:
1. Contraindications to TAVI (e.g., anatomically phenotypes, intracardiac mass, thrombus, vegetation, endocarditis)
2. Refusal to provide informed consent to study enrolment
3. Patients with severe aorta or peripheral artery disease precluding transfemoral approach of TAVI
4. 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.
Primary outcome measure(s)
Primary safety endpoint — 45 days Early safety as defined by VARC-3 as composite of:
* Freedom from all-cause mortality;
* Freedom from all stroke;
* Freedom from VARC 3 type 3-4 bleeding;
* Freedom from major vascular, access-related, or cardiac structural complication;
* Freedom from acute kidney injury stage 3 or 4;
* Freedom from moderate or severe aortic regurgitation;
* Freedom from new permanent pacemaker due to procedure-related conduction abnormalities;
* Freedom from surgery or intervention related to the device.
Primary performance endpoint — 45 days Device success as defined by VARC-3 as composite of:
* Technical success;
* Freedom from mortality;
* Freedom from surgery or intervention related to the device or to a major vascular or access related or cardiac structural complication;
* Intended performance of the valve (mean gradient \<20mmHg, peak velocity \<3 m/s, Doppler velocity index ≥0.25, and less than moderate aortic regurgitation).
Trial sites (4)
Facility
City
Region
Status
Northern General Hospital, Sheffield Teaching Hospitals NHS Foundation Trust
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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