Hydra Single-centre Experience - Copenhagen, Denmark - Trial NCT06342635
Access comprehensive clinical trial information for NCT06342635 through Pure Global AI's free database. This phase not specified trial is sponsored by Sahajanand Medical Technologies Limited and is currently Not yet recruiting. The study focuses on Aortic Valve Stenosis. Target enrollment is 50 participants.
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Study Focus
Sponsor & Location
Sahajanand Medical Technologies Limited
Timeline & Enrollment
N/A
Apr 01, 2024
Oct 31, 2026
Primary Outcome
Primary safety endpoint,Primary performance endpoint
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.
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT06342635
Device Trial