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Hydra Registry - UK

ConditionAortic Valve Stenosis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-99
SponsorSahajanand Medical Technologies Limited

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial population

Patient with severe aortic valve stenosis

Trial design

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

  • 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.

Treatment groups

250 Participants
are divided into 1 treatment group
Group A: Severe aortic valve stenosis1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
45 days
2

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).

Time frame
45 days

Secondary outcomes

1

Technical success

As per VARC-3 defined criteria

Time frame
Immediately after the procedure
2

Cardiovascular mortality

Time frame
45 days, and 1-year
3

All-cause mortality

Time frame
45 days, and 1-year
4

All stroke

Time frame
45 days, and 1-year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sahajanand Medical Technologies Limited

Lead sponsor

Psephos Biomedica

Collaborator

Source ClinicalTrials.gov
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