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PRospective Evaluation Complementing Investigation With Acurate Neo Device (PRECISA)

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ClinicalTrials.gov Identifier: NCT03846557
Recruitment Status : Not yet recruiting
First Posted : February 19, 2019
Last Update Posted : August 2, 2019
Sponsor:
Information provided by (Responsible Party):
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.

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.

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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: PRospective Evaluation Complementing Investigation With Acurate Neo Device
Estimated Study Start Date : September 28, 2019
Estimated Primary Completion Date : February 15, 2020
Estimated Study Completion Date : March 2, 2021

Resource links provided by the National Library of Medicine


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




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



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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.

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


Contacts
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Contact: Raúl Moreno, MD, PhD +34987876135 raulmorenog@hotmail.com
Contact: Fundación EPIC +34987876135 iepic@fundacionepic.org

Locations
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Spain
Hospital Universitari Germans Trias I Pujol Not yet recruiting
Badalona, Barcelona, Spain, 08916
Hospital Universitari Vall D`Hebron Not yet recruiting
Barcelona, Spain, 08035
Hospital Universitari de Bellvitge Not yet recruiting
Barcelona, Spain, 08907
Hospital Universitario de Burgos Not yet recruiting
Burgos, Spain, 09006
Hospital Universitario Virgen de Las Nieves Not yet recruiting
Granada, Spain, 18014
Hospital Universitario Ramon Y Cajal Not yet recruiting
Madrid, Spain, 28034
Hospital Clinico de San Carlos Not yet recruiting
Madrid, Spain, 28040
Hospital Universitario de La Paz Not yet recruiting
Madrid, Spain, 28046
Hospital Universitari I Politècnic de La Fé Not yet recruiting
Valencia, Spain, 46026
Hospital Clinico Universitario de Valladolid Not yet recruiting
Valladolid, Spain, 47003
Sponsors and Collaborators
Fundación EPIC

Publications:

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Responsible Party: Fundación EPIC
ClinicalTrials.gov Identifier: NCT03846557     History of Changes
Other Study ID Numbers: PRECISA -EPIC 11
First Posted: February 19, 2019    Key Record Dates
Last Update Posted: August 2, 2019
Last Verified: August 2019
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
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction