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Hydra Single-centre Experience - Copenhagen, Denmark
Sponsor: Sahajanand Medical Technologies Limited
Summary
The present study aims to evaluate the efficacy and safety of TAVI using the Hydra transcatheter aortic valve (THV) series, in patients with severe aortic stenosis up to 1-year after the procedure. Additionally, the study will assess the role of geometry in the development of new conduction abnormalities based on the analysis of post-operative CT scan at 1-month in patients who had undergone transcatheter aortic valve replacement with a self-expanding Hydra THV series.
Official title: Prospective Observational Single-centre Study on the Efficacy and Safety of Hydra Transcatheter Aortic Valve
Key Details
Gender
All
Age Range
18 Years - 99 Years
Study Type
OBSERVATIONAL
Enrollment
50
Start Date
2024-06-18
Completion Date
2026-10-31
Last Updated
2024-07-05
Healthy Volunteers
No
Conditions
Interventions
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 (1)
Copenhagen University Hospital, Rigshospitalet
Copenhagen, Denmark