EICHORCondition: Aortic Valve Stenosis · Sponsor: Sahajanand Medical Technologies Limited
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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.
This description comes directly from the study's public registry record.
Dr. Javaid Iqbal, MRCP, PhD · 7788438471 · J.Iqbal@sheffield.ac.uk
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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.
Reproduced word-for-word from the public registry record — the study team can answer questions about it.
| Northern General Hospital, Sheffield Teaching Hospitals NHS Foundation Trust | Sheffield, Yorkshire, United Kingdom | Recruiting |
| Royal Victoria Hospital | Belfast, United Kingdom | Not Yet Recruiting |
| Royal Papworth | Cambridge, United Kingdom | Not Yet Recruiting |
| Castle Hill Hull | Cottingham, United Kingdom | Recruiting |
This study lists sites in the areas below. Each link shows other recruiting studies near that city, from the public registry record.
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Source record: clinicaltrials.gov/study/NCT06507579