Hydra Registry - UK

NCT06507579 | Recruiting

• 1 other identifier: HYD/SHEFFIELD-001/2023
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 4

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.

Conditions

Aortic Valve Stenosis

Keywords

Aortic Valve Stenosis, TAVI, Hydra

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (23)

• Technical success

  Immediately after the procedure

• 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

Study Arms (1)

Severe aortic valve stenosis

Hydra transcatheter aortic valve (THV) series

Device: Hydra transcatheter aortic valve (THV) series

Interventions

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.

Severe aortic valve stenosis

Eligibility Criteria

• Age: 18 Years - 99 Years
• Gender Eligibility Details: Male or Female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient with severe aortic valve stenosis

You may qualify if:

• Patients with severe aortic stenosis eligible for transfemoral TAVI procedure as per local Heart Team evaluation
• Full understanding and willing to provide informed consent to study enrolment
• Age ≥ 18 years

You may not qualify if:

• Contraindications to TAVI (e.g., anatomically phenotypes, intracardiac mass, thrombus, vegetation, endocarditis)
• Refusal to provide informed consent to study enrolment
• Patients with severe aorta or peripheral artery disease precluding transfemoral approach of TAVI
• 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.

Sponsors & Collaborators

• Sahajanand Medical Technologies Limited: lead
• Psephos Biomedica: collaborator

Study Sites (4)

Northern General Hospital, Sheffield Teaching Hospitals NHS Foundation Trust

Sheffield, Yorkshire, S5 7AU, United Kingdom

RECRUITING

Royal Victoria Hospital

Belfast, BT12 6BA, United Kingdom

NOT YET RECRUITING

Royal Papworth

Cambridge, CB2 0AY, United Kingdom

NOT YET RECRUITING

Castle Hill Hull

Cottingham, HU16 5JQ, United Kingdom

RECRUITING

MeSH Terms

Conditions

Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Study Officials

• Dr. Javaid Iqbal, MRCP, PhD

  Northern General Hospital, Sheffield Teaching Hospitals NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dr. Javaid Iqbal, MRCP, PhD

CONTACT

7788438471; J.Iqbal@sheffield.ac.uk

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 3, 2024
• First Posted: July 18, 2024
• Study Start: July 11, 2024
• Primary Completion (Estimated): July 11, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: April 27, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (4)