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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

Tracking Information
First Submitted Date February 11, 2019
First Posted Date February 19, 2019
Last Update Posted Date August 2, 2019
Estimated Study Start Date September 28, 2019
Estimated Primary Completion Date February 15, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 21, 2019)
  • 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
  • Cardiovascular death [ Time Frame: 30 days post-index procedure ]
    Cumulative incidence of a combination of all cause Cardiovascular death
Original Primary Outcome Measures
 (submitted: February 17, 2019)
  • Device success [ Time Frame: 7 days ]
    Assessment combined endpoint composed of:
    • 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 [ Time Frame: 30 days post-index procedure ]
    Cumulative incidence of a combination of all cause Cardiovascular death
Change History Complete list of historical versions of study NCT03846557 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: February 21, 2019)
  • 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
  • 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
  • Assesment of NYHA (New York Heart Association ) classification [ Time Frame: 7 days, 30 days, 12 month ]
    Assesment of NYHA classification
  • Assessment of mean aortic gradient post-implantation [ Time Frame: up to one year ]
    Assessment of mean aortic gradient post-implantation
  • 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
Original Secondary Outcome Measures
 (submitted: February 17, 2019)
  • Assessment of combined early safety and clinical efficacy as defined by the Valve Academic Research Consortium-2 (VARC-2) [ Time Frame: 30 days ]
    Assessment of combined early safety and clinical efficacy as defined by the Valve Academic Research Consortium-2 (VARC-2)
    • 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 Time-related valve safety
    • 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 [ Time Frame: 7 days, 30 days, 12 month ]
    Assesment of NYHA classification
  • Assessment of mean aortic gradient post-implantation [ Time Frame: up to one year ]
    Assessment of mean aortic gradient post-implantation
  • Assessment of In-hospital mortality [ Time Frame: date of procedure till date of estimated discharge, assessed up to two weeks ]
    Assessment of In-hospital mortality
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title PRospective Evaluation Complementing Investigation With Acurate Neo Device
Official Title PRospective Evaluation Complementing Investigation With Acurate Neo Device
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 Type Observational
Study Design Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Aortic Stenosis
Intervention Device: Transcatheter Aortic Valve Implantation (TAVI)
Implantation of the Acurate Neo Transcatheter Heart Valve
Study Groups/Cohorts Treatment
Transcatheter Aortic Valve Implantation (TAVI)
Intervention: Device: Transcatheter Aortic Valve Implantation (TAVI)
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Not yet recruiting
Estimated Enrollment
 (submitted: February 17, 2019)
300
Original Estimated Enrollment Same as current
Estimated Study Completion Date March 2, 2021
Estimated Primary Completion Date February 15, 2020   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Raúl Moreno, MD, PhD +34987876135 raulmorenog@hotmail.com
Contact: Fundación EPIC +34987876135 iepic@fundacionepic.org
Listed Location Countries Spain
Removed Location Countries  
 
Administrative Information
NCT Number NCT03846557
Other Study ID Numbers PRECISA -EPIC 11
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Fundación EPIC
Study Sponsor Fundación EPIC
Collaborators Not Provided
Investigators Not Provided
PRS Account Fundación EPIC
Verification Date August 2019