PRospective Evaluation Complementing Investigation With Acurate Neo Device (PRECISA)

Fundación EPIC

Status: Completed

Conditions: Aortic Stenosis

Treatments: Device: Transcatheter Aortic Valve Implantation (TAVI)

Study type: Observational

Funder types: Other

Identifiers

NCT03846557

PRECISA -EPIC 11

Details and patient eligibility

About

The study collects real-world data of patients who were treated with the Acurate Neo TAVI System and evaluates early and midterm clinical outcomes.

Full 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.

Enrollment: 300 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

300 participants in 1 patient group

Treatment

Description:

Transcatheter Aortic Valve Implantation (TAVI) Device

Treatment:

Device: Transcatheter Aortic Valve Implantation (TAVI)