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Recruiting NCT06507579

Hydra Registry - UK

— Observational Aortic Valve Stenosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Hydra transcatheter aortic valve (THV) series.
Who it may be relevant to
Registry conditions: Aortic Valve Stenosis. Basic parameters: 18 years — 99 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United Kingdom
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Prospective Observational Study on the Efficacy and Safety of Hydra Transcatheter Aortic Valve

Overview

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).

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.

Primary outcome measures

  • Primary safety endpoint [Time frame: 45 days]
  • Primary performance endpoint [Time frame: 45 days]
Secondary outcome measures (12)
  • Technical success [Time frame: Immediately after the procedure]
  • Cardiovascular mortality [Time frame: 45 days, and 1-year]
  • All-cause mortality [Time frame: 45 days, and 1-year]
  • All stroke [Time frame: 45 days, and 1-year]
  • Disabling stroke [Time frame: 45 days, and 1-year]
  • Myocardial infarction [Time frame: 45 days, and 1-year]
  • Major vascular complication [Time frame: 45 days]
  • Acute kidney injury [Time frame: 45 days]
  • New permanent pacemaker implantation due to procedure related conduction abnormalities [Time frame: 45 days, and 1-year]
  • New-onset atrial fibrillation [Time frame: 45 days, and 1-year]
  • Coronary artery obstruction requiring intervention [Time frame: 45 days, and 1-year]
  • Re-hospitalization for procedure- or valve-related causes [Time frame: 45 days, and 1-year]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-only

Study locations

United Kingdom · 4 centers
  • Northern General Hospital, Sheffield Teaching Hospitals NHS Foundation Trust — Sheffield
  • Royal Victoria Hospital — Belfast
  • Royal Papworth — Cambridge
  • Castle Hill Hull — Cottingham

Identifiers

NCT: NCT06507579 · HYD/SHEFFIELD-001/2023

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗