Status:
COMPLETED
5 Year Observation of Patients With PORTICO Valves
Lead Sponsor:
Abbott Medical Devices
Conditions:
Aortic Valve Stenosis
Eligibility:
All Genders
18+ years
Brief Summary
The purpose of this clinical investigation is to further assess the performance and safety profile of the commercially-available Portico™ TAVI System in patients with severe symptomatic aortic stenosi...
Detailed Description
This is an international multicenter, prospective, non-randomized clinical investigation without concurrent or matched control, designed to assess the mid-term safety and performance of the Portico va...
Eligibility Criteria
Inclusion
- Patient has signed the Patient Informed Consent prior to participating in the clinical investigation.
- Patient has been referred for a Portico Valve implant as per Heart Team decision or patient has received a Portico Valve as per participation in an SJM sponsored regulatory or first-in-human trial.
- Patient has senile degenerative aortic valve stenosis confirmed by echocardiographically derived criteria\*:
- An initial aortic valve area (AVA) of less than or equal to (≤) 1.0 cm2 (or indexed EOA less than or equal to (≤) 0.6 cm2/m2) AND
- A mean gradient greater than (\>)40 mmHg or jet velocity greater than (\>)4.0 m/s or Doppler Velocity Index less than (\<)0.25. If the mean gradient is \<40 mmHg and left ventricular ejection fraction (LVEF) \<55%, then the site may as well perform a dobutamine stress echo to see if the mean gradient increases to \>40 mmHg." (Baseline measurement taken by echo within 6 months of index procedure.)
- Patient has a life expectancy more than (\>) 12 months.
- For patients enrolled in a French site:
- Patient is at high risk for surgery as demonstrated by a Logistic EuroSCORE equal or more than (≥) 20 and/or a Society of Thoracic Surgeon (STS) mortality risk score of more than (\>) 10% and/or by clinical judgment of the Heart Team based on the individual risk profile (comorbidities).
- Not applicable for a patient who has received a Portico Valve as per participation in an SJM sponsored Regulatory or First-In-Human trial.
Exclusion
- Any case in which the Portico Valve would not be indicated for the patient as per current instructions for use (i.e any "off-label" use).
- Patient has any other aortic valve than tricuspid one.
- Patient has a prosthetic valve or ring in the aortic position.
- Patient needs a concomitant structural heart procedure..
- Patient needs the usage of an embolic protection device.
- Patient is unwilling or unable to comply with all clinical investigation-required follow-up evaluations.
- Patient is pregnant
Key Trial Info
Start Date :
April 16 2013
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 19 2022
Estimated Enrollment :
1032 Patients enrolled
Trial Details
Trial ID
NCT01802788
Start Date
April 16 2013
End Date
October 19 2022
Last Update
February 11 2025
Active Locations (60)
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1
Royal Adelaide Hospital
Adelaide, Australia
2
St Andrews Hospital
Adelaide, Australia
3
Heart Care Partners-Wesley Hospital
Auchenflower, Australia
4
The Prince Charles Hospital
Chermside, Australia