Hydra Registry - UK

Recruiting

• Conditions: Aortic Valve Stenosis
• Interventions: Device: Hydra transcatheter aortic valve (THV) series

• Registration Number: NCT06507579
• Lead Sponsor: Sahajanand Medical Technologies Limited

Brief 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 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:

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).

Study Timeline

• Study First Submitted: 2024-07-03
• Study Start: 2024-07-11
• Study First Submitted QC: 2024-07-11
• Study First Posted: 2024-07-18
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-18
• Last Update Posted: 2025-02-19
• Primary Completion: 2026-07-11
• Study Completion: 2026-08-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 250

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Severe aortic valve stenosis	Hydra transcatheter aortic valve (THV) series	Hydra transcatheter aortic valve (THV) series

Primary Outcome Measures

Name	Time	Method
Primary safety endpoint	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	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).

Secondary Outcome Measures

Name	Time	Method
Cardiovascular mortality	45 days, and 1-year
All-cause mortality	45 days, and 1-year
All stroke	45 days, and 1-year
Technical success	Immediately after the procedure	As per VARC-3 defined criteria
Coronary artery obstruction requiring intervention	45 days, and 1-year
Re-hospitalization for procedure- or valve-related causes	45 days, and 1-year
Mean aortic valve gradient	45 days, and 1-year
Effective Orifice Area (EOA)	45 days, and 1-year
Paravalvular leak	45 days, and 1-year
New-onset atrial fibrillation	45 days, and 1-year
New York Heart Association (NYHA) functional class	45 days, and 1-year
Disabling stroke	45 days, and 1-year
Myocardial infarction	45 days, and 1-year
Major vascular complication	45 days
Acute kidney injury	45 days
New permanent pacemaker implantation due to procedure related conduction abnormalities	45 days, and 1-year
Change in quality-of-life score assessed by the Kansas City Cardiomyopathy Questionnaire (KCCQ-12)	45 days, and 1-year	Assessed by the Kansas City Cardiomyopathy Questionnaire (KCCQ-12)
Bioprosthetic Valve Failure (BVF), defined as valve-related mortality or aortic valve re-operation/re-intervention, or stage 3 haemodynamic severe structural valve deterioration	45 days, and 1-year
Bioprosthetic valve dysfunction (BVD), defined as structural valve deterioration, non-structural valve deterioration, clinical valve thrombosis, infective endocarditis	45 days, and 1-year
Stroke or peripheral embolism (presumably valve-related, after ruling out other non-valve aetiologies)	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)	45 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

Trial Locations

Locations (4)

Northern General Hospital, Sheffield Teaching Hospitals NHS Foundation Trust; 🇬🇧 Sheffield, Yorkshire, United Kingdom

Royal Victoria Hospital; 🇬🇧 Belfast, United Kingdom

Royal Papworth; 🇬🇧 Cambridge, United Kingdom

Castle Hill Hull; 🇬🇧 Cottingham, United Kingdom