Clinical trial NCT03846557: PRospective Evaluation Complementing Investigation With Acurate Neo Device
Official title: PRospective Evaluation Complementing Investigation With Acurate Neo Device
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Aortic Stenosis
Keywords: TAVI
Valve
Lead sponsor: Fundación EPIC
Sponsor class: OTHER
First posted: 2019-02-19
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
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.

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 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.

Primary outcomes:
measure: Device success of implantation
timeFrame: 7 days
measure: Cardiovascular death
timeFrame: 30 days post-index procedure
Secondary outcomes:
measure: Assessment of early safety
timeFrame: 30 days
measure: Assessment of time-related valve safety
timeFrame: 30 days
measure: Assesment of NYHA (New York Heart Association ) classification
timeFrame: 7 days, 30 days, 12 month
measure: Assessment of mean aortic gradient post-implantation
timeFrame: up to one year
measure: Death during the hospitalization of the patient
timeFrame: date of procedure till date of estimated discharge, assessed up to two weeks
Other outcomes:
Locations:
city: Badalona
country: Spain
facility: Hospital Universitari Germans Trias I Pujol
state: Barcelona
city: Barcelona
country: Spain
facility: Hospital Universitari Vall D'Hebron
city: Barcelona
country: Spain
facility: Hospital Universitari de Bellvitge
city: Burgos
country: Spain
facility: Hospital Universitario de Burgos
city: Granada
country: Spain
facility: Hospital Universitario Virgen de Las Nieves
city: Madrid
country: Spain
facility: Hospital Universitario Ramon Y Cajal
city: Madrid
country: Spain
facility: Hospital Clinico de San Carlos
city: Madrid
country: Spain
facility: Hospital Universitario de La Paz
city: Valencia
country: Spain
facility: Hospital Universitari I Politècnic de La Fé
city: Valladolid
country: Spain
facility: Hospital Clinico Universitario de Valladolid
Study officials:
References:
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