Hydra Registry - UK

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.

Study Overview

• Status: Recruiting
• Conditions: Aortic Valve Stenosis
• Intervention / Treatment: Device: Hydra transcatheter aortic valve (THV) series

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 Type: Observational
• Enrollment (Estimated): 250

Contacts and Locations

• Study Contact: Name: Dr. Javaid Iqbal, MRCP, PhD; Phone Number: 7788438471; Email: J.Iqbal@sheffield.ac.uk

Study Locations

• United Kingdom
  • Belfast, United Kingdom, BT12 6BA
    • Not yet recruiting
    • Royal Victoria Hospital
  • Cambridge, United Kingdom, CB2 0AY
    • Not yet recruiting
    • Royal Papworth
  • Cottingham, United Kingdom, HU16 5JQ
    • Recruiting
    • Castle Hill Hull
  • Yorkshire
    • Sheffield, Yorkshire, United Kingdom, S5 7AU
      • Recruiting
      • Northern General Hospital, Sheffield Teaching Hospitals NHS Foundation Trust
      • Contact: Dr. Javaid Iqbal, MRCP, PhD; Phone Number: 7788438471; Email: J.Iqbal@sheffield.ac.uk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patient with severe aortic valve stenosis

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Severe aortic valve stenosis; Hydra transcatheter aortic valve (THV) series	Device: Hydra transcatheter aortic valve (THV) series; The Hydra device consists of a self-expanding nitinol frame and three bovine pericardial leaflets in supra-annular position.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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).	45 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Technical success	As per VARC-3 defined criteria	Immediately after the procedure
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
Cardiovascular mortality		45 days, and 1-year
All-cause mortality		45 days, and 1-year
All stroke		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
New-onset atrial fibrillation		45 days, and 1-year
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 York Heart Association (NYHA) functional class		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)	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		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

Collaborators and Investigators

• Sponsor: Sahajanand Medical Technologies Limited
• Collaborators: Psephos Biomedica
• Investigators: Principal Investigator: Dr. Javaid Iqbal, MRCP, PhD, Northern General Hospital, Sheffield Teaching Hospitals NHS Foundation Trust

Study record dates

Study Major Dates

• Study Start (Actual): July 11, 2024
• Primary Completion (Estimated): July 11, 2026
• Study Completion (Estimated): August 1, 2026

Study Registration Dates

• First Submitted: July 3, 2024
• First Submitted That Met QC Criteria: July 11, 2024
• First Posted (Actual): July 18, 2024

Study Record Updates

• Last Update Posted (Actual): April 27, 2026
• Last Update Submitted That Met QC Criteria: April 22, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Aortic Valve Stenosis, TAVI, Hydra
• Additional Relevant MeSH Terms: Aortic Valve Disease; Cardiovascular Diseases; Heart Diseases; Heart Valve Diseases; Ventricular Outflow Obstruction; Aortic Valve Stenosis
• Other Study ID Numbers: HYD/SHEFFIELD-001/2023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No