PRospective Evaluation Complementing Investigation With Acurate Neo Device

Fundación EPIC300 enrolled

Overview

The study collects real-world data of patients who were treated with the Acurate Neo TAVI System and evaluates early and midterm clinical outcomes.

Study Type

OBSERVATIONAL

Enrollment

300

Conditions

Aortic Stenosis

Interventions

Transcatheter Aortic Valve Implantation (TAVI)DEVICE

Implantation of the Acurate Neo Transcatheter Heart Valve

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (10)

Hospital Universitari Germans Trias I Pujol

Badalona, Barcelona, Spain

Hospital Universitari Vall D'Hebron

Barcelona, Spain

Hospital Universitari de Bellvitge

Barcelona, Spain

Hospital Universitario de Burgos

Outcomes

Primary Outcomes

Device success of implantation

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

Time frame: 7 days

Cardiovascular death

Cumulative incidence of a combination of all cause Cardiovascular death

Time frame: 30 days post-index procedure

Secondary Outcomes

Assessment of early safety

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

Time frame: 30 days

Assessment of time-related valve safety

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

Time frame: 30 days

Assesment of NYHA (New York Heart Association ) classification

Assesment of NYHA classification

Time frame: 7 days, 30 days, 12 month

Data from ClinicalTrials.gov

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