5 Year Observation of Patients With PORTICO Valves (PORTICO-1)

Abbott

Status

Completed

Conditions

Aortic Valve Stenosis

Treatments

Device: St Jude Medical Portico replacement aortic valve

Procedure: Transcatheter Aortic Valve Implant

Study type

Observational

Funder types

Industry

Identifiers

NCT01802788

CV-12-054-EU-PV

Details and patient eligibility

About

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 stenosis.

Full 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 valve in patients with severe symptomatic aortic stenosis whom are high risk for surgical valve replacement. The primary endpoint is 1 year all-cause mortality. In addition, the performance and safety profile of the Portico valve will be further evaluated at 30 days, 1 year, and annually through 5 years post-implant.

The investigation will be conducted at approximately 65 centers in approximately 15 countries in Europe, Middle-East, Africa, Canada, Australia and New Zealand.

Enrollment

1,032 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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 criteria

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