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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.
Full description
This is a prospective, observational, multi-centre study. The aim of this study is to collect clinical, procedural, and follow-up data in order to evaluate the efficacy and safety of the Hydra THV series (Vascular Innovations Co. Ltd., Nonthaburi, Thailand).
Additionally, the study will conduct the following evaluation:
Following discharge, clinical follow-ups are scheduled at 45 days (±14 days), and 1-year (±30 days).
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250 participants in 1 patient group
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Central trial contact
Dr. Javaid Iqbal, MRCP, PhD
Data sourced from clinicaltrials.gov
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