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NCT06342635

Hydra Single-centre Experience - Copenhagen, Denmark

Prospective Observational Single-centre Study on the Efficacy and Safety of Hydra Transcatheter Aortic Valve
Sahajanand Medical Technologies Limited·ClinicalTrials.gov·device·Device trialNot yet recruiting
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Study focus
Disease/Condition
Aortic Valve Stenosis
Drug/Device/Intervention
Hydra Transcatheter Aortic Valve (THV) Series
Study type
Observational
Intervention type
device
Sponsor & location
Primary sponsor
Sahajanand Medical Technologies Limited
Location
Copenhagen, Denmark
Timeline & enrollment
Phase
N/A
Start date
Apr 01, 2024
End date
Oct 31, 2026
Enrollment
50 participants
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
Aortic (valve) stenosisAortic (valve) stenosis with insufficiencyCongenital stenosis of aortic valveStenosis of aortaRheumatic aortic stenosis
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06342635
Type
Device Trial
About this record

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.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.