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PRospective Evaluation Complementing Investigation With Acurate Neo Device (PRECISA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03846557
Recruitment Status : Active, not recruiting
First Posted : February 19, 2019
Last Update Posted : January 4, 2022
Sponsor:
Information provided by (Responsible Party):
Fundación EPIC

Study Description
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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.

Condition or disease Intervention/treatment
Aortic Stenosis Device: Transcatheter Aortic Valve Implantation (TAVI)

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 Design
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Study Type : Observational
Actual Enrollment : 300 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: PRospective Evaluation Complementing Investigation With Acurate Neo Device
Actual Study Start Date : May 20, 2019
Estimated Primary Completion Date : November 2, 2022
Estimated Study Completion Date : November 2, 2022

Resource links provided by the National Library of Medicine


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


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03846557


Locations
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Spain
Hospital Universitari Germans Trias I Pujol
Badalona, Barcelona, Spain, 08916
Hospital Universitari Vall D'Hebron
Barcelona, Spain, 08035
Hospital Universitari de Bellvitge
Barcelona, Spain, 08907
Hospital Universitario de Burgos
Burgos, Spain, 09006
Hospital Universitario Virgen de Las Nieves
Granada, Spain, 18014
Hospital Universitario Ramon Y Cajal
Madrid, Spain, 28034
Hospital Clinico de San Carlos
Madrid, Spain, 28040
Hospital Universitario de La Paz
Madrid, Spain, 28046
Hospital Universitari I Politècnic de La Fé
Valencia, Spain, 46026
Hospital Clinico Universitario de Valladolid
Valladolid, Spain, 47003
Sponsors and Collaborators
Fundación EPIC
More Information
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Publications:

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Responsible Party: Fundación EPIC
ClinicalTrials.gov Identifier: NCT03846557    
Other Study ID Numbers: PRECISA -EPIC 11
First Posted: February 19, 2019    Key Record Dates
Last Update Posted: January 4, 2022
Last Verified: January 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Fundación EPIC:
TAVI
Valve
Additional relevant MeSH terms:
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Aortic Valve Stenosis
Aortic Valve Disease
Heart Valve Diseases
 Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction