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
- Are there results?
- Not yet: the study is under way
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
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Observational Study on the Efficacy and Safety of Hydra Transcatheter Aortic Valve
- ClinicalTrials.gov ID
- NCT06507579
- Acronym / sponsor ID
- HYD/SHEFFIELD-001/2023
- Conditions
- Aortic Valve Stenosis
- Keywords
- Aortic Valve Stenosis, TAVI, Hydra
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Sahajanand Medical Technologies LimitedIndustry (pharma, biotech, devices)
- Collaborators
- Psephos Biomedica
- Study start
- 11 Jul 2024 (actual)
- Primary completion
- 11 Jul 2027 (estimated)
- Study completion
- 1 Aug 2027 (estimated)
- First posted
- 18 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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).
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Severe aortic valve stenosis | – | Device: Hydra transcatheter aortic valve (THV) seriesHydra transcatheter aortic valve (THV) series |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient with severe aortic valve stenosis
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hydra transcatheter aortic valve (THV) seriesThe Hydra device consists of a self-expanding nitinol frame and three bovine pericardial leaflets in supra-annular position. | Device | Severe aortic valve stenosis |
Primary outcome
Primary safety endpoint
Time frame: 45 days
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.
Primary performance endpoint
Time frame: 45 days
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).
23 secondary outcomes
Technical success
Time frame: Immediately after the procedure
Cardiovascular mortality
Time frame: 45 days, and 1-year
All-cause mortality
Time frame: 45 days, and 1-year
All stroke
Time frame: 45 days, and 1-year
Disabling stroke
Time frame: 45 days, and 1-year
Myocardial infarction
Time frame: 45 days, and 1-year
Major vascular complication
Time frame: 45 days
Acute kidney injury
Time frame: 45 days
New permanent pacemaker implantation due to procedure related conduction abnormalities
Time frame: 45 days, and 1-year
New-onset atrial fibrillation
Time frame: 45 days, and 1-year
Coronary artery obstruction requiring intervention
Time frame: 45 days, and 1-year
Re-hospitalization for procedure- or valve-related causes
Time frame: 45 days, and 1-year
Mean aortic valve gradient
Time frame: 45 days, and 1-year
Effective Orifice Area (EOA)
Time frame: 45 days, and 1-year
Paravalvular leak
Time frame: 45 days, and 1-year
New York Heart Association (NYHA) functional class
Time frame: 45 days, and 1-year
Change in quality-of-life score assessed by the Kansas City Cardiomyopathy Questionnaire (KCCQ-12)
Time frame: 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
Time frame: 45 days, and 1-year
Bioprosthetic valve dysfunction (BVD), defined as structural valve deterioration, non-structural valve deterioration, clinical valve thrombosis, infective endocarditis
Time frame: 45 days, and 1-year
Stroke or peripheral embolism (presumably valve-related, after ruling out other non-valve aetiologies)
Time frame: 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)
Time frame: 45 days, and 1-year
Significant arrhythmias on rACM that would potentially lead to permanent pacemaker implantation (PPMI)
Time frame: 72 hours post hospital discharge
Ability to selectively engage and obtain diagnostic epicardial coronary angiography images from the right and left coronary ostia
Time frame: Immediately post-TAVI
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dr. Javaid Iqbal, MRCP, PhD principal investigator
Northern General Hospital, Sheffield Teaching Hospitals NHS Foundation Trust
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aortic Valve Stenosis, run by Sahajanand Medical Technologies Limited at 4 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dr. Javaid Iqbal, MRCP, PhD (7788438471, J.Iqbal@sheffield.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary safety endpoint (time frame: 45 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2026.