Skip to main content
OpenTrials
Completed

NCT Number: NCT03846557

PRospective Evaluation Complementing Investigation With Acurate Neo Device

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Aortic Stenosis Aortic Valve Disease Aortic Valve Stenosis Cardiovascular Diseases Heart Diseases Heart Valve Diseases Ventricular Outflow Obstruction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Universitari Germans Trias I Pujol, Badalona, Barcelona, Spain

Loading trial locations.

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Transcatheter Aortic Valve Implantation (TAVI)

Device

Implantation of the Acurate Neo Transcatheter Heart Valve

Primary outcomes

  1. Device success of implantation

    Time frame: 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

  2. Cardiovascular death

    Time frame: 30 days post-index procedure

    Cumulative incidence of a combination of all cause Cardiovascular death

Secondary outcomes

  1. Assessment of early safety

    Time frame: 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

  2. Assessment of time-related valve safety

    Time frame: 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

  3. Assesment of NYHA (New York Heart Association ) classification

    Time frame: 7 days, 30 days, 12 month

    Assesment of NYHA classification

  4. Assessment of mean aortic gradient post-implantation

    Time frame: up to one year

    Assessment of mean aortic gradient post-implantation

  5. Death during the hospitalization of the patient

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Fundación EPIC

Other

Registry information

Acronym: PRECISA

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Feb 19, 2019
Registry last updated
Jun 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.