Aortic Valve Stenosis
Conditions
Keywords
Aortic Valve Stenosis, TAVI, Hydra
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).
Interventions
The Hydra device consists of a self-expanding nitinol frame and three bovine pericardial leaflets in supra-annular position.
Sponsors
Sahajanand Medical Technologies Limited
Psephos Biomedica
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary safety endpoint | 45 days | 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. |
| Primary performance endpoint | 45 days | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Technical success | Immediately after the procedure | As per VARC-3 defined criteria |
| Cardiovascular mortality | 45 days, and 1-year | — |
| All-cause mortality | 45 days, and 1-year | — |
| All stroke | 45 days, and 1-year | — |
| Disabling stroke | 45 days, and 1-year | — |
| Myocardial infarction | 45 days, and 1-year | — |
| Major vascular complication | 45 days | — |
| Acute kidney injury | 45 days | — |
| New permanent pacemaker implantation due to procedure related conduction abnormalities | 45 days, and 1-year | — |
| New-onset atrial fibrillation | 45 days, and 1-year | — |
| Coronary artery obstruction requiring intervention | 45 days, and 1-year | — |
| Re-hospitalization for procedure- or valve-related causes | 45 days, and 1-year | — |
| Mean aortic valve gradient | 45 days, and 1-year | — |
| Effective Orifice Area (EOA) | 45 days, and 1-year | — |
| Paravalvular leak | 45 days, and 1-year | — |
| New York Heart Association (NYHA) functional class | 45 days, and 1-year | — |
| Change in quality-of-life score assessed by the Kansas City Cardiomyopathy Questionnaire (KCCQ-12) | 45 days, and 1-year | Assessed by the Kansas City Cardiomyopathy Questionnaire (KCCQ-12) |
| Bioprosthetic Valve Failure (BVF), defined as valve-related mortality or aortic valve re-operation/re-intervention, or stage 3 haemodynamic severe structural valve deterioration | 45 days, and 1-year | — |
| Bioprosthetic valve dysfunction (BVD), defined as structural valve deterioration, non-structural valve deterioration, clinical valve thrombosis, infective endocarditis | 45 days, and 1-year | — |
| Stroke or peripheral embolism (presumably valve-related, after ruling out other non-valve aetiologies) | 45 days, and 1-year | — |
| 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) | 45 days, and 1-year | — |
| Significant arrhythmias on rACM that would potentially lead to permanent pacemaker implantation (PPMI) | 72 hours post hospital discharge | — |
| Ability to selectively engage and obtain diagnostic epicardial coronary angiography images from the right and left coronary ostia | Immediately post-TAVI | — |
Countries
United Kingdom
Contacts
CONTACTDr. Javaid Iqbal, MRCP, PhD
PRINCIPAL_INVESTIGATORDr. Javaid Iqbal, MRCP, PhD
Northern General Hospital, Sheffield Teaching Hospitals NHS Foundation Trust
Outcome results
None listed