Prospective Observational Single-centre Study on the Efficacy and Safety of Hydra Transcatheter Aortic Valve
Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Observational
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 99
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
Denmark
Copenhagen University Hospital, Rigshospitalet
RECRUITING
Copenhagen
Contact Information
Primary
Dr. Ole De Backer
ole.debacker@gmail.com
+4527605009
Time Frame
Start Date: 2024-06-18
Estimated Completion Date: 2026-10-31
Participants
Target number of participants: 50
Related Therapeutic Areas
Sponsors
Collaborators: Qmed Consulting A/S
Leads: Sahajanand Medical Technologies Limited