Status:
COMPLETED
PRospective Evaluation Complementing Investigation With Acurate Neo Device
Lead Sponsor:
Fundación EPIC
Conditions:
Aortic Stenosis
Eligibility:
All Genders
18+ years
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.
Eligibility Criteria
Inclusion
- ≥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
- 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.
Key Trial Info
Start Date :
May 20 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 2 2021
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT03846557
Start Date
May 20 2019
End Date
October 2 2021
Last Update
June 18 2025
Active Locations (10)
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1
Hospital Universitari Germans Trias I Pujol
Badalona, Barcelona, Spain, 08916
2
Hospital Universitari Vall D'Hebron
Barcelona, Spain, 08035
3
Hospital Universitari de Bellvitge
Barcelona, Spain, 08907
4
Hospital Universitario de Burgos
Burgos, Spain, 09006