Hydra Registry - Sheffield Experience
NCT Number: NCT06507579
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Aortic Valve Stenosis
Interventions: DEVICE: Hydra transcatheter aortic valve (THV) series
Sponsor: Sahajanand Medical Technologies Limited
Collaborators: Psephos Biomedica
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 50
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-11
Completion Date: 2026-08-01
Locations: Northern General Hospital, Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, Yorkshire, S5 7AU, United Kingdom

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. 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.

Primary Outcome Measures: 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., 30 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)., 30 days
Secondary Outcome Measures: Technical success, As per VARC-3 defined criteria, Immediately after the procedure|Cardiovascular mortality, 30 days, and 1-year|All-cause mortality, 30 days, and 1-year|All stroke, 30 days, and 1-year|Disabling stroke, 30 days, and 1-year|Myocardial infarction, 30 days, and 1-year|Major vascular complication, 30 days|Acute kidney injury, 30 days|New permanent pacemaker implantation due to procedure related conduction abnormalities, 30 days, and 1-year|New-onset atrial fibrillation, 30 days, and 1-year|Coronary artery obstruction requiring intervention, 30 days, and 1-year|Re-hospitalization for procedure- or valve-related causes, 30 days, and 1-year|Mean aortic valve gradient, 30 days, and 1-year|Effective Orifice Area (EOA), 30 days, and 1-year|Paravalvular leak, 30 days, and 1-year|New York Heart Association (NYHA) functional class, 30 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), 30 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, 30 days, and 1-year|Bioprosthetic valve dysfunction (BVD), defined as structural valve deterioration, non-structural valve deterioration, clinical valve thrombosis, infective endocarditis, 30 days, and 1-year|Stroke or peripheral embolism (presumably valve-related, after ruling out other non-valve aetiologies), 30 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), 30 days, and 1-year|Significant arrhythmias on rACM that would potentially lead to permanent pacemaker implantation (PPMI), 72 hours post hospital discharge|Ability to selectively engage and obtain diagnostic epicardial coronary angiography images from the right and left coronary ostia, Immediately post-TAVI