Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
50 participants
OBSERVATIONAL
2024-06-18
2026-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
2. Patients affected by severe aortic stenosis (NYHA class ≥ II) eligible for TAVI procedure as per local Heart Team evaluation
3. Full understanding and willing to provide informed consent to study enrolment
Exclusion Criteria
2. Refusal to provide informed consent to study enrolment
3. Patients with severe aorta or peripheral artery disease precluding transfemoral approach of TAVI
4. Patients with calcification on the annulus and in the Left Ventricular Outflow Tract (LVOT), or/and excess calcium within each cusp, or those who are deemed unsuitable for the Hydra THV series based on the clinical judgment of the Investigator
18 Years
99 Years
ALL
No
Sponsors
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Qmed Consulting A/S
INDUSTRY
Sahajanand Medical Technologies Limited
INDUSTRY
Responsible Party
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Locations
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Copenhagen University Hospital, Rigshospitalet
Copenhagen, , Denmark
Countries
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Central Contacts
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Facility Contacts
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Dr. Ole De Backer
Role: primary
Other Identifiers
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HYD/DENMARK-001/2023
Identifier Type: -
Identifier Source: org_study_id
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