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Hydra Registry - UK

Recruitingn/aAges 18 Years - 99 YearsAllSahajanand Medical Technologies Limited
NCT06507579 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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.
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What it tests

  • Hydra transcatheter aortic valve (THV) series
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Where

4 sites
Northern General Hospital, Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield, United Kingdom
Royal Victoria Hospital
Belfast, United Kingdom
Royal Papworth
Cambridge, United Kingdom
Castle Hill Hull
Cottingham, United Kingdom
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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