At a glance
- What the study gets you
- Health checks and monitoring — no treatment given
- Type of study
- Observational (no treatment given)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Hydra transcatheter aortic valve (THV) series (device)
- How long the study runs
- Study runs about 37 months (dates as stated)
- About the drug or intervention
- Hydra transcatheter aortic valve (THV) series — device: The Hydra device consists of a self-expanding nitinol frame and three bovine pericardial leaflets in supra-annular position.
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Observing health over time
- Ages
- 18 Years to 99 Years
- Who
- All
- Number of participants
- 250
- Started
- 2024-07-11
- Last checked
- 2026-08
Plain English Summary
What is this study?
- • Testing a new treatment for aortic valve stenosis
- • Clinical study - 250 participants
- • 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
Who can take part?
- • Ages 18 Years to 99 Years
- • Diagnosed with aortic valve stenosis
Where?
- • Sheffield - Northern General Hospital, Sheffield Teaching Hospitals NHS Foundation Trust
- • Belfast - Royal Victoria Hospital
- • Cambridge - Royal Papworth
- • Cottingham - Castle Hill Hull
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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.
More detail
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: 1. 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. 2. 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).
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years - 99 Years
- Who can join: All genders
What the study is looking for
- ✓Patients with severe aortic stenosis eligible for transfemoral TAVI procedure as per local Heart Team evaluation
- ✓Full understanding and willing to provide agreement to take part to study enrolment
- ✓Age ≥ 18 years
Who cannot take part
- ✗Contraindications to TAVI (e.g., anatomically phenotypes, intracardiac mass, thrombus, vegetation, endocarditis)
- ✗Refusal to provide agreement to take part to study enrolment
- ✗Patients with severe aorta or peripheral artery disease precluding transfemoral approach of TAVI
See the full criteria
Where Is This Study? (4 UK sites)
Northern General Hospital, Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield S5 7AU, United Kingdom
Royal Victoria Hospital
Belfast BT12 6BA, United Kingdom
Royal Papworth
Cambridge CB2 0AY, United Kingdom
Castle Hill Hull
Cottingham HU16 5JQ, United Kingdom
James Illingworth
hyp-tr.development.research@nhs.net01482 461883 or 461903How to Get in Touch
Dr. Javaid Iqbal, MRCP, PhD
Sponsor contactCONTACT