Hydra Single-centre Experience - Copenhagen, Denmark
Key facts
- Where
- Copenhagen, DenmarkSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 99 years old?
Source: NCT06342635, who can take part
Where in Denmark
- Copenhagen University Hospital, RigshospitaletCopenhagen, DenmarkContact: Dr. Ole De BackerTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Sahajanand Medical Technologies Limited
- Trial code
- NCT06342635
- Record updated
- 27 April 2026
- Original description
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.Read full original descriptionShow less
Prospective Observational Single-centre Study on the Efficacy and Safety of Hydra Transcatheter Aortic Valve
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.
Inclusion: Age ≥ 18 years; Patients affected by severe aortic stenosis (NYHA class ≥ II) eligible for TAVI procedure as per local Heart Team evaluation; Full understanding and willing to provide informed consent to study enrolment.
Exclusion: Patients with severe aorta or peripheral artery disease precluding transfemoral approach of TAVI; 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; Contraindications to TAVI (e.g., anatomically phenotypes, intracardiac mass, thrombus, vegetation, endocarditis); Refusal to provide informed consent to study enrolment.