PRospective Evaluation Complementing Investigation With Acurate Neo Device (PRECISA)

June 14, 2025 updated by: Fundación EPIC
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 Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain, 08035
        • Hospital Universitari Vall d'Hebrón
      • Barcelona, Spain, 08907
        • Hospital Universitari de Bellvitge
      • Burgos, Spain, 09006
        • Hospital Universitario de Burgos
      • Granada, Spain, 18014
        • Hospital Universitario Virgen de las Nieves
      • Madrid, Spain, 28034
        • Hospital Universitario Ramon y Cajal
      • Madrid, Spain, 28046
        • Hospital Universitario de La Paz
      • Madrid, Spain, 28040
        • Hospital Clinico de San Carlos
      • Valencia, Spain, 46026
        • Hospital Universitari I Politècnic de La Fe
      • Valladolid, Spain, 47003
        • Hospital Clínico Universitario de Valladolid
    • Barcelona
      • Badalona, Barcelona, Spain, 08916
        • Hospital Universitari Germans Trias i Pujol

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with 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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Treatment
Transcatheter Aortic Valve Implantation (TAVI) Device
Device: Transcatheter Aortic Valve Implantation (TAVI)
Implantation of the Acurate Neo Transcatheter Heart Valve

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
7 days
Cardiovascular death
Time Frame: 30 days post-index procedure
Cumulative incidence of a combination of all cause Cardiovascular death
30 days post-index procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
30 days
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
30 days
Assesment of NYHA (New York Heart Association ) classification
Time Frame: 7 days, 30 days, 12 month
Assesment of NYHA classification
7 days, 30 days, 12 month
Assessment of mean aortic gradient post-implantation
Time Frame: up to one year
Assessment of mean aortic gradient post-implantation
up to one year
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
date of procedure till date of estimated discharge, assessed up to two weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundación EPIC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 20, 2019

Primary Completion (Actual)

September 2, 2021

Study Completion (Actual)

October 2, 2021

Study Registration Dates

First Submitted

February 11, 2019

First Submitted That Met QC Criteria

February 17, 2019

First Posted (Actual)

February 19, 2019

Study Record Updates

Last Update Posted (Actual)

June 18, 2025

Last Update Submitted That Met QC Criteria

June 14, 2025

Last Verified

January 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRECISA -EPIC 11

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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