Aortic Valve StenosisNCT06507579
Hydra Registry - UK
An observational study of Aortic Valve Stenosis, run by Sahajanand Medical Technologies Limited at 4 sites in United Kingdom.
Trial 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 up to 1-year after the procedure. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Aortic Valve Stenosis
- What is being tested?
- Hydra transcatheter aortic valve (THV) series
- Type of treatment
- Medical device
- How many people
- 250 participants
- Where
- 4 sitesUnited Kingdom
- Study dates
- 11 Jul 2024to 1 Aug 2027
- How long will I take part?
- 1 Year
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient with severe aortic valve stenosis
Who may be able to join
- 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 join
- 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.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom4 sites, 4 recruiting
- Not yet recruiting
Royal Victoria Hospital
Belfast, BT12 6BA
- Not yet recruiting
Royal Papworth
Cambridge, CB2 0AY
- Recruiting
Castle Hill Hull
Cottingham, HU16 5JQ
- Recruiting
Northern General Hospital, Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield, Yorkshire, S5 7AU
Dr. Javaid Iqbal, MRCP, PhD, 7788438471, J.Iqbal@sheffield.ac.uk
About this study
Official title: Prospective Observational Study on the Efficacy and Safety of Hydra Transcatheter Aortic Valve
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.
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.
Read the 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 series (Vascular Innovations Co. Ltd., Nonthaburi, Thailand).
Additionally, the study will conduct the following evaluation:
- The remote ambulatory cardiac monitoring (rACM) using the Checkpoint Cardio System, consisting of 72 hours of continuous electrocardiogram (ECG) monitoring, will be evaluated post hospital discharge where it is clinically appropriate.
- Coronary access will be evaluated immediately post-TAVI by attempting to selectively engage both the right and left coronary arteries through standardised angiographic views. This will be done in a sub-set of patients who are either known to have coronary artery disease, did not have coronary angiogram prior to TAVI or where it is felt to be clinically appropriate for other reasons post implant.
Following discharge, clinical follow-ups are scheduled at 45 days (±14 days), and 1-year (±30 days).
- Conditions
- Aortic Valve Stenosis
- Being tested
- Hydra transcatheter aortic valve (THV) series
- Keywords
- Aortic Valve Stenosis, TAVI, Hydra
- Medical subject headings
- Aortic Valve Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydra transcatheter aortic valve (THV) seriesDevice
The Hydra device consists of a self-expanding nitinol frame and three bovine pericardial leaflets in supra-annular position.
| Study group | Role | What they receive |
|---|---|---|
| Severe aortic valve stenosis | Hydra transcatheter aortic valve (THV) series Receives: Device: Hydra transcatheter aortic valve (THV) series |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary safety endpoint
Early safety as defined by VARC-3 as composite of:
- Freedom from all-cause mortality;
- Freedom from all stroke;
- Freedom from VARC 3 type 3-4 bleeding;
- Freedom from major vascular, access-related, or cardiac structural complication;
- Freedom from acute kidney injury stage 3 or 4;
- Freedom from moderate or severe aortic regurgitation;
- Freedom from new permanent pacemaker due to procedure-related conduction abnormalities;
- Freedom from surgery or intervention related to the device.
Measured: 45 days
Primary performance endpoint
Device success as defined by VARC-3 as composite of:
- Technical success;
- Freedom from mortality;
- Freedom from surgery or intervention related to the device or to a major vascular or access related or cardiac structural complication;
- Intended performance of the valve (mean gradient <20mmHg, peak velocity <3 m/s, Doppler velocity index ≥0.25, and less than moderate aortic regurgitation).
Measured: 45 days
Secondary outcomes (23)
Technical success
As per VARC-3 defined criteria
Measured: Immediately after the procedure
Cardiovascular mortality
Measured: 45 days, and 1-year
All-cause mortality
Measured: 45 days, and 1-year
All stroke
Measured: 45 days, and 1-year
Disabling stroke
Measured: 45 days, and 1-year
Myocardial infarction
Measured: 45 days, and 1-year
Major vascular complication
Measured: 45 days
Acute kidney injury
Measured: 45 days
New permanent pacemaker implantation due to procedure related conduction abnormalities
Measured: 45 days, and 1-year
New-onset atrial fibrillation
Measured: 45 days, and 1-year
Coronary artery obstruction requiring intervention
Measured: 45 days, and 1-year
Re-hospitalization for procedure- or valve-related causes
Measured: 45 days, and 1-year
Mean aortic valve gradient
Measured: 45 days, and 1-year
Effective Orifice Area (EOA)
Measured: 45 days, and 1-year
Paravalvular leak
Measured: 45 days, and 1-year
New York Heart Association (NYHA) functional class
Measured: 45 days, and 1-year
Change in quality-of-life score assessed by the Kansas City Cardiomyopathy Questionnaire (KCCQ-12)
Assessed by the Kansas City Cardiomyopathy Questionnaire (KCCQ-12)
Measured: 45 days, and 1-year
Bioprosthetic Valve Failure (BVF), defined as valve-related mortality or aortic valve re-operation/re-intervention, or stage 3 haemodynamic severe structural valve deterioration
Measured: 45 days, and 1-year
Bioprosthetic valve dysfunction (BVD), defined as structural valve deterioration, non-structural valve deterioration, clinical valve thrombosis, infective endocarditis
Measured: 45 days, and 1-year
Stroke or peripheral embolism (presumably valve-related, after ruling out other non-valve aetiologies)
Measured: 45 days, and 1-year
VARC-3 Type 3-4 bleeding secondary to or exacerbated by antiplatelet or anticoagulant agents used specifically for valve-related concerns (e.g., clinically apparent leaflet thrombosis)
Measured: 45 days, and 1-year
Significant arrhythmias on rACM that would potentially lead to permanent pacemaker implantation (PPMI)
Measured: 72 hours post hospital discharge
Ability to selectively engage and obtain diagnostic epicardial coronary angiography images from the right and left coronary ostia
Measured: Immediately post-TAVI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2024
- Study start11 Jul 2024
- Primary completion11 Jul 2027 (estimated)
- Study completion1 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic Valve StenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 250 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Sahajanand Medical Technologies Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Psephos Biomedica
- Responsible party
- Sponsor
- Investigators
- Dr. Javaid Iqbal, MRCP, PhD, Principal investigator, Northern General Hospital, Sheffield Teaching Hospitals NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06507579
- Sponsor's protocol ID
- HYD/SHEFFIELD-001/2023
- Status last verified
- Aug 2026
- First submitted
- 3 Jul 2024
- Last updated
- 18 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No