Status:
RECRUITING
Hydra Registry - UK
Lead Sponsor:
Sahajanand Medical Technologies Limited
Collaborating Sponsors:
Psephos Biomedica
Conditions:
Aortic Valve Stenosis
Eligibility:
All Genders
18-99 years
Brief Summary
The study will evaluate the efficacy and safety of transcatheter aortic valve implantation (TAVI) using the Hydra transcatheter aortic heart valve (THV) series, in patients with severe aortic stenosis...
Detailed Description
This is a prospective, observational, multi-centre study. The aim of this study is to collect clinical, procedural, and follow-up data in order to evaluate the efficacy and safety of the Hydra THV ser...
Eligibility Criteria
Inclusion
- Patients with severe aortic stenosis eligible for transfemoral TAVI procedure as per local Heart Team evaluation
- Full understanding and willing to provide informed consent to study enrolment
- Age ≥ 18 years
Exclusion
- 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 significant calcification of the aortic 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.
Key Trial Info
Start Date :
July 11 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
August 1 2026
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT06507579
Start Date
July 11 2024
End Date
August 1 2026
Last Update
February 19 2025
Active Locations (4)
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1
Northern General Hospital, Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield, Yorkshire, United Kingdom, S5 7AU
2
Royal Victoria Hospital
Belfast, United Kingdom, BT12 6BA
3
Royal Papworth
Cambridge, United Kingdom, CB2 0AY
4
Castle Hill Hull
Cottingham, United Kingdom, HU16 5JQ