International long-term follow-up study of patients implanted with a PORTICO* valve

Completed

• Conditions: Aorta Stenosis - aorta valve calcification; 10046973

• Registration Number: NL-OMON43837
• Lead Sponsor: St. Jude Medical

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 30

Inclusion Criteria

1. Patient has signed the Patient Informed Consent prior to participating in the clinical investigation.
2. Patient has been referred for a Portico Valve implant as per Heart Team decision.
3. Patient has senile degenerative aortic valve stenosis confirmed by echocardiographically derived criteria
4. Patient has a life expectancy of more than (>) 12 months.

Exclusion Criteria

1. Any case in which the Portico Valve would not be indicated for the patient as per current IFU (i.e. any *off-label* use).
2. Patient has any other aortic valve than tricuspid one.
3. Patient has a prosthetic valve or ring in the aortic position.
4. Patient needs a concomitant structural heart procedure.
5. Patient is unwilling or unable to comply with all clinical investigation-required follow-up evaluations.
6. Patient is pregnant

Study & Design

• Study Type: Observational non invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoint is all-cause mortality at 1 year post implant (according<br /><br>to VARC-2)</p><br>