Aortic Stenosis
Conditions
Keywords
TAVI, Valve
Brief summary
The study collects real-world data of patients who were treated with the Acurate Neo TAVI System and evaluates early and midterm clinical outcomes.
Detailed description
The study collects real-world data of patients who were treated with the Acurate Neo TAVI System and evaluates early and midterm clinical outcomes.
Interventions
Implantation of the Acurate Neo Transcatheter Heart Valve
Sponsors
Fundación EPIC
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* ≥18 years. * Severe aortic stenosis with indication of implantation of aortic valve prosthesis in which an Acurate Neo device is implanted according to the indications for use. * Has signed the Patient Informed Consent Form.
Exclusion criteria
* Severe aortic stenosis without indication of implantation of aortic valve prosthesis in which an Acurate Neo device is implanted according to the indications for use.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Device success of implantation | 7 days | Proportion of patients with device success of implantation defined as: * absence of procedural mortality AND * correct positioning of a single prosthetic heart valve into the proper anatomical location AND * no prosthesis - patient mismatch AND * mean aortic valve gradient \<20 mmHg, AND * no moderate or severe prosthetic valve regurgitation |
| Cardiovascular death | 30 days post-index procedure | Cumulative incidence of a combination of all cause Cardiovascular death |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assesment of NYHA (New York Heart Association ) classification | 7 days, 30 days, 12 month | Assesment of NYHA classification |
| Assessment of early safety | 30 days | Proportion of patients with early safety defined by the Valve Academic Research Consortium-2 (VARC-2) as: * All-cause mortality * All stroke (disabling and non-disabling) * Life-threatening bleeding * Acute kidney injury-Stage 2 or 3 (including renal replacement therapy) * Coronary artery obstruction requiring intervention * Major vascular complication * Valve-related dysfunction requiring repeat procedure |
| Death during the hospitalization of the patient | date of procedure till date of estimated discharge, assessed up to two weeks | Proportion of patients with death during the hospitalization designated by the VARC-2 criteria |
| Assessment of mean aortic gradient post-implantation | up to one year | Assessment of mean aortic gradient post-implantation |
| Assessment of time-related valve safety | 30 days | Proportion of patients with structural valve deterioration as defined by: * Requiring repeat procedure (transcatheter or surgical heart valve replacement) * Valve-related dysfunction defined by * mean aortic valve gradient ≥20 mmHg and * no moderate or severe prosthetic valve regurgitation * Prosthetic valve endocarditis * Prosthetic valve thrombosis * Thrombo-embolic events (e.g. stroke) * VARC bleeding, unless clearly unrelated to valve therapy |
Countries
Spain
Outcome results
None listed