Evaluating the Hydra heart valve for aortic valve stenosis
Prospective Observational Study on the Efficacy and Safety of Hydra Transcatheter Aortic Valve
Sahajanand Medical Technologies Limited · NCT06507579
This study is testing how well the Hydra heart valve works and is safe for people with severe aortic stenosis after they have the valve implanted.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 250 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Sponsor | Sahajanand Medical Technologies Limited (industry) |
| Locations | 4 sites (Sheffield, Yorkshire and 3 other locations) |
| Trial ID | NCT06507579 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the efficacy and safety of the Hydra transcatheter aortic heart valve series in patients with severe aortic stenosis over a one-year period following the transcatheter aortic valve implantation (TAVI) procedure. It will collect clinical, procedural, and follow-up data, including evaluations of coronary access post-implantation and the use of remote ambulatory continuous electrocardiogram monitoring for 72 hours after discharge. The study will involve multiple centers and will follow patients for clinical outcomes at 45 days and one year.
Who should consider this trial
Good fit: Ideal candidates include patients aged 18 and older with severe aortic stenosis who are eligible for transfemoral TAVI as determined by their local Heart Team.
Not a fit: Patients with contraindications to TAVI or those deemed unsuitable for the Hydra THV series will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve treatment outcomes for patients with severe aortic stenosis by providing insights into the safety and efficacy of the Hydra heart valve.
How similar studies have performed: Other studies have shown success with similar transcatheter heart valve approaches, indicating a promising avenue for treatment.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patients with severe aortic stenosis eligible for transfemoral TAVI procedure as per local Heart Team evaluation 2. Full understanding and willing to provide informed consent to study enrolment 3. Age ≥ 18 years Exclusion Criteria: 1. Contraindications to TAVI (e.g., anatomically phenotypes, intracardiac mass, thrombus, vegetation, endocarditis) 2. Refusal to provide informed consent to study enrolment 3. Patients with severe aorta or peripheral artery disease precluding transfemoral approach of TAVI 4. 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.
Where this trial is running
Sheffield, Yorkshire and 3 other locations
- Northern General Hospital, Sheffield Teaching Hospitals NHS Foundation Trust — Sheffield, Yorkshire, United Kingdom (RECRUITING)
- Royal Victoria Hospital — Belfast, United Kingdom (NOT_YET_RECRUITING)
- Royal Papworth — Cambridge, United Kingdom (NOT_YET_RECRUITING)
- Castle Hill Hull — Cottingham, United Kingdom (RECRUITING)
Study contacts
- Principal investigator: Dr. Javaid Iqbal, MRCP, PhD — Northern General Hospital, Sheffield Teaching Hospitals NHS Foundation Trust
- Study coordinator: Dr. Javaid Iqbal, MRCP, PhD
- Email: J.Iqbal@sheffield.ac.uk
- Phone: 7788438471
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Aortic Valve Stenosis, Aortic Valve Stenosis, TAVI, Hydra