Hydra Single-centre Experience - Copenhagen, Denmark
ConditionAortic Valve Stenosis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-99
SponsorSahajanand Medical Technologies Limited
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
Contraindications to TAVI (e.g., anatomically phenotypes, intracardiac mass, thrombus, vegetation, endocarditis)
Refusal to provide informed consent to study enrolment
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
Trial design
Treatments tested in this trial
- Hydra Transcatheter Aortic Valve (THV) Series
Treatment groups
No treatment groups listed
Locations
1Copenhagen University Hospital, Rigshospitalet Copenhagen Denmark
Sponsors and collaborators
Sahajanand Medical Technologies Limited
Lead sponsor
Qmed Consulting A/S
Collaborator
Source ClinicalTrials.gov