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RECRUITINGOBSERVATIONAL

Hydra Registry - UK

Prospective Observational Study on the Efficacy and Safety of Hydra Transcatheter Aortic Valve

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

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.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Patients with severe aortic stenosis eligible for transfemoral TAVI procedure as per local Heart Team evaluation 2. Full understanding and willing to provide willing to sign a consent form to study enrolment 3. Age ≥ 18 years Who Should NOT Join This Trial: 1. Contraindications to TAVI (e.g., anatomically phenotypes, intracardiac mass, thrombus, vegetation, endocarditis) 2. Refusal to provide willing to sign a consent form 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

DEVICE

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