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Hydra Registry - UK

NCT06507579 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 250

Last updated 2026-04-27

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Psephos Biomedica

    collaborator UNKNOWN

  • Sahajanand Medical Technologies Limited

    lead INDUSTRY

Principal Investigators

  • Dr. Javaid Iqbal, MRCP, PhD · Northern General Hospital, Sheffield Teaching Hospitals NHS Foundation Trust

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-11
Primary Completion
2026-07-11
Completion
2026-08-01

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06507579 on ClinicalTrials.gov