PRospective Evaluation Complementing Investigation With Acurate Neo Device

Completed

• Conditions: Aortic Stenosis

• Registration Number: NCT03846557
• Lead Sponsor: Fundación EPIC

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.

Study Timeline

• Study First Submitted: 2019-02-11
• Study First Submitted QC: 2019-02-17
• Study First Posted: 2019-02-19
• Study Start: 2019-05-20
• Primary Completion: 2021-09-02
• Study Completion: 2021-10-02
• Status Verified: 2022-01
• Last Update Submitted: 2025-06-14
• Last Update Posted: 2025-06-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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
Assesment of NYHA (New York Heart Association ) classification	7 days, 30 days, 12 month	Assesment of NYHA classification
Assessment of mean aortic gradient post-implantation	up to one year	Assessment of mean aortic gradient post-implantation
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

Trial Locations

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; 🇪🇸 Burgos, Spain

Hospital Universitario Virgen de Las Nieves; 🇪🇸 Granada, Spain

Hospital Universitario Ramon Y Cajal; 🇪🇸 Madrid, Spain

Hospital Clinico de San Carlos; 🇪🇸 Madrid, Spain

Hospital Universitario de La Paz; 🇪🇸 Madrid, Spain

Hospital Universitari I Politècnic de La Fé; 🇪🇸 Valencia, Spain

Hospital Clinico Universitario de Valladolid; 🇪🇸 Valladolid, Spain