Clinical trial NCT06507579: Hydra Registry - UK
Official title: Prospective Observational Study on the Efficacy and Safety of Hydra Transcatheter Aortic Valve
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Aortic Valve Stenosis
Keywords: Aortic Valve Stenosis, TAVI, Hydra
Lead sponsor: Sahajanand Medical Technologies Limited
Sponsor class: INDUSTRY
Collaborators: name: Psephos Biomedica
First posted: 2024-07-18
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient with severe aortic valve stenosis

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.

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).

Eligibility criteria: Inclusion Criteria:

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

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 transfemoral approach of TAVI
4. 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.

Primary outcomes:
measure: Primary safety endpoint
timeFrame: 45 days
measure: Primary performance endpoint
timeFrame: 45 days
Secondary outcomes:
measure: Technical success
timeFrame: Immediately after the procedure
measure: Cardiovascular mortality
timeFrame: 45 days, and 1-year
measure: All-cause mortality
timeFrame: 45 days, and 1-year
measure: All stroke
timeFrame: 45 days, and 1-year
measure: Disabling stroke
timeFrame: 45 days, and 1-year
measure: Myocardial infarction
timeFrame: 45 days, and 1-year
measure: Major vascular complication
timeFrame: 45 days
measure: Acute kidney injury
timeFrame: 45 days
measure: New permanent pacemaker implantation due to procedure related conduction abnormalities
timeFrame: 45 days, and 1-year
measure: New-onset atrial fibrillation
timeFrame: 45 days, and 1-year
measure: Coronary artery obstruction requiring intervention
timeFrame: 45 days, and 1-year
measure: Re-hospitalization for procedure- or valve-related causes
timeFrame: 45 days, and 1-year
measure: Mean aortic valve gradient
timeFrame: 45 days, and 1-year
measure: Effective Orifice Area (EOA)
timeFrame: 45 days, and 1-year
measure: Paravalvular leak
timeFrame: 45 days, and 1-year
measure: New York Heart Association (NYHA) functional class
timeFrame: 45 days, and 1-year
measure: Change in quality-of-life score assessed by the Kansas City Cardiomyopathy Questionnaire (KCCQ-12)
timeFrame: 45 days, and 1-year
measure: Bioprosthetic Valve Failure (BVF), defined as valve-related mortality or aortic valve re-operation/re-intervention, or stage 3 haemodynamic severe structural valve deterioration
timeFrame: 45 days, and 1-year
measure: Bioprosthetic valve dysfunction (BVD), defined as structural valve deterioration, non-structural valve deterioration, clinical valve thrombosis, infective endocarditis
timeFrame: 45 days, and 1-year
measure: Stroke or peripheral embolism (presumably valve-related, after ruling out other non-valve aetiologies)
timeFrame: 45 days, and 1-year
measure: VARC-3 Type 3-4 bleeding secondary to or exacerbated by antiplatelet or anticoagulant agents used specifically for valve-related concerns (e.g., clinically apparent leaflet thrombosis)
timeFrame: 45 days, and 1-year
measure: Significant arrhythmias on rACM that would potentially lead to permanent pacemaker implantation (PPMI)
timeFrame: 72 hours post hospital discharge
measure: Ability to selectively engage and obtain diagnostic epicardial coronary angiography images from the right and left coronary ostia
timeFrame: Immediately post-TAVI
Other outcomes:
Locations:
city: Sheffield
country: United Kingdom
facility: Northern General Hospital, Sheffield Teaching Hospitals NHS Foundation Trust
state: Yorkshire
city: Belfast
country: United Kingdom
facility: Royal Victoria Hospital
city: Cambridge
country: United Kingdom
facility: Royal Papworth
city: Cottingham
country: United Kingdom
facility: Castle Hill Hull
Study officials:
affiliation: Northern General Hospital, Sheffield Teaching Hospitals NHS Foundation Trust
name: Dr. Javaid Iqbal, MRCP, PhD
role: PRINCIPAL_INVESTIGATOR
References: