Hydra Registry - UK

Last updated: February 18, 2025
Sponsor: Sahajanand Medical Technologies Limited
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Hydra transcatheter aortic valve (THV) series

Clinical Study ID

NCT06507579
HYD/SHEFFIELD-001/2023
  • Ages 18-99
  • All Genders

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Patients with severe aortic stenosis eligible for transfemoral TAVI procedure as perlocal Heart Team evaluation

  2. Full understanding and willing to provide informed consent to study enrolment

  3. Age ≥ 18 years

Exclusion

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 transfemoralapproach of TAVI

  4. Patients with significant calcification of the aortic annulus and in the LeftVentricular Outflow Tract (LVOT), or/and excess calcium within each cusp, or thosewho are deemed unsuitable for the Hydra THV series based on the clinical judgment ofthe Investigator.

Study Design

Total Participants: 250
Treatment Group(s): 1
Primary Treatment: Hydra transcatheter aortic valve (THV) series
Phase:
Study Start date:
July 11, 2024
Estimated Completion Date:
August 01, 2026

Study 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).

Connect with a study center

  • Northern General Hospital, Sheffield Teaching Hospitals NHS Foundation Trust

    Sheffield, Yorkshire S5 7AU
    United Kingdom

    Active - Recruiting

  • Royal Victoria Hospital

    Belfast, BT12 6BA
    United Kingdom

    Site Not Available

  • Royal Papworth

    Cambridge, CB2 0AY
    United Kingdom

    Site Not Available

  • Castle Hill Hull

    Cottingham, HU16 5JQ
    United Kingdom

    Active - Recruiting

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