Aortic Valve Stenosis
Conditions
Keywords
Aortic Valve Stenosis, TAVI, Hydra
Brief summary
The present study aims to evaluate the efficacy and safety of TAVI using the Hydra transcatheter aortic valve (THV) series, in patients with severe aortic stenosis up to 1-year after the procedure. Additionally, the study will assess the role of geometry in the development of new conduction abnormalities based on the analysis of post-operative CT scan at 1-month in patients who had undergone transcatheter aortic valve replacement with a self-expanding Hydra THV series.
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
Qmed Consulting A/S
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. Age ≥ 18 years 2. Patients affected by severe aortic stenosis (NYHA class ≥ II) eligible for TAVI procedure as per local Heart Team evaluation 3. Full understanding and willing to provide informed consent to study enrolment
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 calcification on the 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 | 30 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 | 30 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 |
|---|---|
| Technical success | Immediately after procedure |
| Cardiovascular mortality | 30 days, and 1-year |
| All-cause mortality | 30 days, and 1-year |
| All stroke | 30 days, and 1-year |
| Disabling stroke | 30 days, and 1-year |
| Myocardial infarction | 30 days, and 1-year |
| Major vascular complication | 30 days |
| Acute kidney injury | 30 days |
| New permanent pacemaker implantation due to procedure related conduction abnormalities | 30 days, and 1-year |
| New-onset atrial fibrillation | 30 days, and 1-year |
| Coronary artery obstruction requiring intervention | 30 days, and 1-year |
| Re-hospitalization for procedure- or valve-related causes | 30 days, and 1-year |
| Mean aortic valve gradient | 30 days, and 1-year |
| Effective Orifice Area (EOA) | 30 days, and 1-year |
| Paravalvular leak | 30 days, and 1-year |
| New York Heart Association (NYHA) functional class | 30 days, and 1-year |
| Quality-of-life evaluation | 30 days, and 1-year |
| Bioprosthetic Valve Failure (BVF) | 30 days, and 1-year |
| Bioprosthetic valve dysfunction (BVD) | 30 days, and 1-year |
| Stroke or peripheral embolism | 30 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 | 30 days, and 1-year |
| Rates of Hypoattenuated Leaflet Thickening (HALT) | 30 days |
| Rates of Reduced leaflet motion (RLM) | 30 days |
| Commissural alignment | 30 days |
Countries
Denmark
Contacts
CONTACTDr. Ole De Backer
Outcome results
None listed