Hydra heart valve replacement in people with severe aortic valve stenosis
Follows adults with severe aortic stenosis after receiving a Hydra transcatheter aortic valve.
Key facts
- Who runs it
- Sahajanand Medical Technologies Limited
- Where
- Belfast, Cambridge, Cottingham, and Sheffield, United KingdomSee the 4 sites
- Trial code
- Registry title
- Hydra Registry - UK
- Status
- Recruiting
- People taking part
- 250 people, planned
- Started
- 11 Jul 2024
- Expected to end
- 1 Aug 2027
- Type of study
- Observational
- Treatments tested
- Hydra transcatheter aortic valve (THV) series
- Record updated
- 18 August 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with severe aortic stenosis, a narrowing of the main heart valve. The local Heart Team must judge that they can have a TAVI procedure through the groin artery. The trial follows people who get the Hydra valve.
- Age
- 18 Years to 99 Years
- Sex
- All sexes can join
- Disease stage
- Severe aortic stenosis. The local Heart Team must judge that a valve replacement through the groin artery (transfemoral TAVI) is possible.
Main reasons for not taking part
- Reasons TAVI cannot be done, such as a mass, blood clot, growth or infection (endocarditis) in the heart
- Severe disease of the aorta or leg arteries that blocks access through the groin
- Heavy calcium build-up in the valve ring, the outflow area of the left heart chamber, or the valve flaps
- The study doctor judges the Hydra valve is not right for the person
- Not willing to give informed consent
The registry criteria, word for word
Show all 7 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
- Contraindications to TAVI (e.g., anatomically phenotypes, intracardiac mass, thrombus, vegetation, endocarditis)
- Refusal to provide informed consent to study enrolment
Check if you might fit
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?
Where in United Kingdom
- Royal Victoria HospitalBelfast, United KingdomContact: Dr. Javaid Iqbal, MRCP, PhDNot yet recruiting
- Royal PapworthCambridge, United KingdomContact: Dr. Javaid Iqbal, MRCP, PhDNot yet recruiting
- Castle Hill HullCottingham, United KingdomContact: Dr. Javaid Iqbal, MRCP, PhDTaking people
- Northern General Hospital, Sheffield Teaching Hospitals NHS Foundation TrustSheffield, United KingdomContact: Dr. Javaid Iqbal, MRCP, PhDTaking people
About the trial
What the trial wants to find out
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 up to 1-year after the procedure. This will include an evaluation of the preservation of coronary access post implant by attempting to selectively engage both the right and left coronary arteries through standardised angiographic views.
Read full original descriptionShow less
The study will also examine the utility of 72 hours of post discharge remote ambulatory continuous electrocardiogram (ECG) monitoring using the novel Checkpoint Cardio System where it is clinically appropriate.
The group in the trial
- Severe aortic valve stenosis
Hydra transcatheter aortic valve (THV) series
Treatment: Hydra transcatheter aortic valve (THV) series
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 doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Prospective Observational Study on the Efficacy and Safety of Hydra Transcatheter Aortic Valve
- Plain-language title
- Hydra heart valve replacement in people with severe aortic valve stenosisGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 14 November 2026.
- Fit questions
- Built from NCT06507579, who can take part
- Record updated
- 18 August 2026