Actively Recruiting
Hydra Single-centre Experience - Copenhagen, Denmark
Led by Sahajanand Medical Technologies Limited · Updated on 2026-04-27
50
Participants Needed
1
Research Sites
175 weeks
Total Duration
On this page
Sponsors
S
Sahajanand Medical Technologies Limited
Lead Sponsor
Q
Qmed Consulting A/S
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Hydra Single-centre Experience - Copenhagen, Denmark
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Diagnosis of severe aortic stenosis with NYHA class II or higher
- Eligible for TAVI procedure based on local Heart Team evaluation
- Able to fully understand and willing to provide informed consent for study participation
You will not qualify if you...
- Contraindications to TAVI such as specific anatomical phenotypes, intracardiac mass, thrombus, vegetation, or endocarditis
- Refusal to provide informed consent for study participation
- Severe aorta or peripheral artery disease preventing transfemoral TAVI approach
- Presence of calcification on the annulus or left ventricular outflow tract, excess calcium on valve cusps, or deemed unsuitable for the Hydra THV device by the Investigator's clinical judgment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Copenhagen University Hospital, Rigshospitalet
Copenhagen, Denmark
Actively Recruiting
Research Team
D
Dr. Ole De Backer
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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