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Completed

NCT Number: NCT01802788

5 Year Observation of Patients With PORTICO Valves

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.

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Key information

Conditions

Aortic Valve Stenosis Aortic Valve Disease Cardiovascular Diseases Heart Diseases Heart Valve Diseases Ventricular Outflow Obstruction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Royal Adelaide Hospital, Adelaide, Australia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

St Jude Medical Portico replacement aortic valve

Device

Transcatheter Aortic Valve Implant

Procedure

Other names: TAVI, Transcatheter Aortic Valve Replacement, TAVR

Primary outcomes

  1. Percentage of Participants With All-cause Mortality

    Time frame: 1 year post implant

    Percentage of participants that died for any reason at 1 year post implantation

Secondary outcomes

  1. Percentage of Participants With All Cause Mortality in Cohort A

    Time frame: 30 days through 5 years post implant

    Percentage of participants that died for any reason at 30 days through 5 years post implantation

  2. Number of Participants With All-cause Mortality (30 Days, Annually From 1 Year Through 5 Years) in Cohort B

    Time frame: 30 days through 5 years post implant

    Number of participants who died for any reason at different time points such as 30 days, 1 year, 2 years, 3 years, 4 years and 5 years.

  3. Percentage of Participants With Cardiovascular Mortality as Defined by the Valve Academic Research Consortium-2 (VARC-2) in Cohort A

    Time frame: 30 days through 5 years post implant

    Percentage of participants that died for cardiovascular or unknown reasons as defined by VARC-2 at 30 days through 5 years post implantation

  4. Number of Participants With Cardiovascular Mortality Occurring at Each Time Window (30 Days, 1 Year, 2 Years, 3 Years, 4 Years and 5 Years) in Cohort B

    Time frame: 30 days through 5 years post implant

    Number of participants who died for any reason at different time points such as 30 days, 1 year, 2 years, 3 years, 4 years and 5 years.

  5. Percentage of Participants With Non-Cardiovascular Mortality as Defined by the Valve Academic Research Consortium-2 (VARC-2) in Cohort A

    Time frame: 30 days through 5 years post implant

    Percentage of participants that died for any reason at 30 days through 5 years post implantation

  6. Number of Participants With Non-Cardiovascular Mortality Occurring at Each Time Window (30 Days, 1 Year, 2 Years, 3 Years, 4 Years and 5 Years) in Cohort B

    Time frame: 30 days through 5 years post implant

    Number of participants who died for any reason at different time points such as 30 days, 1 year, 2 years, 3 years, 4 years and 5 years.

  7. Percentage of Participants With Myocardial Infarction as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort A

    Time frame: 30 days through 5 years post implant

    Percentage of participants with a myocardial infarction as defined by VARC-2 at 30 days through 5 years post implantation post implantation

  8. Number of Participants With Myocardial Infarction as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort B

    Time frame: 30 days through 5 years post implant

    Number of participants with a myocardial infarction as defined by VARC-2 at 30 days through 5 years post implantation post implantation

  9. Percentage of Participants With Vascular Access Site Complication as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort A

    Time frame: 30 days post implant

    Percentage of participants with vascular access site complication (major or minor) as defined by VARC-2 at 30 days post implantation

  10. Percentage of Participants With Bleeding Events as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort A

    Time frame: 30 days post implant

    Percentage of participants with a bleeding events (life threatening, major or minor) as defined by VARC-2 at 30 days post implantation

  11. Percentage of Participants With Stage 1, 2 and 3 Acute Kidney Injury as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort A

    Time frame: 30 days post implant

    Percentage of participants with a Stage 1, 2 or Stage 3 acute kidney injury as defined by VARC-2 at 30 days post implantation

  12. Mean Prosthetic Valve Function as Defined by Valve Academic Research Consortium-2 (VARC-2) (Aortic Valve Area)

    Time frame: 30 days through 5 years post implant

    The aortic valve area as interpreted by an independent echocardiographic core laboratory at 30 days through 5 years post implantation

  13. Mean Prosthetic Valve Function as Defined by Valve Academic Research Consortium-2 (VARC-2) (Mean Transvalvular Gradient)

    Time frame: 30 days through 5 years post implant

    The mean transvalvular gradient as interpreted by an independent echocardiographic core laboratory at 30 days through 5 years post implantation

  14. Number of Participants With New York Heart Association (NYHA) Functional Classification of Heart Failure

    Time frame: 30 days post implant

    The New York Heart Association (NYHA) Functional Classification provides a simple way of classifying the extent of heart failure. It classifies patients in one of four categories based on their limitations during physical activity:

    Class I - No symptoms and no limitation in ordinary physical activity; Class II - Mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity; Class III - Marked limitation in activity due to symptoms; Class IV - Severe limitations.

  15. Number of Participants With New York Heart Association (NYHA) Functional Classification of Heart Failure

    Time frame: 1 year post implant

    The New York Heart Association (NYHA) Functional Classification provides a simple way of classifying the extent of heart failure. It classifies patients in one of four categories based on their limitations during physical activity:

    Class I - No symptoms and no limitation in ordinary physical activity; Class II - Mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity; Class III - Marked limitation in activity due to symptoms; Class IV - Severe limitations.

  16. Number of Participants With New York Heart Association (NYHA) Functional Classification of Heart Failure

    Time frame: 2 years post implant

    The New York Heart Association (NYHA) Functional Classification provides a simple way of classifying the extent of heart failure. It classifies patients in one of four categories based on their limitations during physical activity:

    Class I - No symptoms and no limitation in ordinary physical activity; Class II - Mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity; Class III - Marked limitation in activity due to symptoms; Class IV - Severe limitations.

  17. Number of Participants With New York Heart Association (NYHA) Functional Classification of Heart Failure

    Time frame: 3 years post implant

    The New York Heart Association (NYHA) Functional Classification provides a simple way of classifying the extent of heart failure. It classifies patients in one of four categories based on their limitations during physical activity:

    Class I - No symptoms and no limitation in ordinary physical activity; Class II - Mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity; Class III - Marked limitation in activity due to symptoms; Class IV - Severe limitations.

  18. Number of Participants With New York Heart Association (NYHA) Functional Classification of Heart Failure

    Time frame: 4 years post implant

    The New York Heart Association (NYHA) Functional Classification provides a simple way of classifying the extent of heart failure. It classifies patients in one of four categories based on their limitations during physical activity:

    Class I - No symptoms and no limitation in ordinary physical activity; Class II - Mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity; Class III - Marked limitation in activity due to symptoms; Class IV - Severe limitations.

  19. Number of Participants With New York Heart Association (NYHA) Functional Classification of Heart Failure

    Time frame: 5 years post implant

    The New York Heart Association (NYHA) Functional Classification provides a simple way of classifying the extent of heart failure. It classifies patients in one of four categories based on their limitations during physical activity:

    Class I - No symptoms and no limitation in ordinary physical activity; Class II - Mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity; Class III - Marked limitation in activity due to symptoms; Class IV - Severe limitations.

  20. Mean Six Minute Walk Test (6MWT)

    Time frame: 30 days through 5 years post implant

    Distance in metres that the participant can walk in 6 minutes. The six-minute walking test (6MWT) is a commonly used objective measure of functional exercise capacity in individuals with moderately severe impairment.

  21. Mean Quality of Life Assessment in Cohort A

    Time frame: 30 days and 1 year post implant

    EuroQuol-5 Dimensions (EQ5D) is a standardized instrument for use as a measure of health outcome applicable to a wide range of health conditions and treatments. A visual analog scale (VAS) for health is also included in the measure as a patient-reported estimate of overall health status. This scale ranges between 0-100, where 0 is 'the worst health you can imagine' and 100 is 'the best health you can imagine'.

  22. Percentage of Participants With Transient Ischemic Attack in Cohort A

    Time frame: 30 days through 5 years post implantation

    Percentage of participants with transient ischemic attack as defined by VARC-2 at 30 days through 5 years post implantation

  23. Number of Participants With Transient Ischemic Attack in Cohort B

    Time frame: 30 days through 5 years post implantation

    Number of participants with transient ischemic attack as defined by VARC-2 at 30 days through 5 years post implantation

  24. Percentage of Participants With Stroke as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort A

    Time frame: 30 days post implant

    Percentage of participants with a stroke (disabling and non-disabling) as defined by VARC-2 at 30 days post implantation

  25. Percentage of Participants With Stroke as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort A

    Time frame: 1 year post implant

    Percentage of participants with a stroke (disabling and non-disabling) as defined by VARC-2 at 1 year post implantation

  26. Percentage of Participants With Stroke as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort A

    Time frame: 2 years post implant

    Percentage of participants with a stroke (disabling and non-disabling) as defined by VARC-2 at 2 years post implantation

  27. Percentage of Participants With Stroke as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort A

    Time frame: 3 years post implant

    Percentage of participants with a stroke (disabling and non-disabling) as defined by VARC-2 at 3 years post implantation

  28. Percentage of Participants With Stroke as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort A

    Time frame: 4 years post implant

    Percentage of participants with a stroke (disabling and non-disabling) as defined by VARC-2 at 4 years post implantation

  29. Percentage of Participants With Stroke as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort A

    Time frame: 5 years post implant

    Percentage of participants with a stroke (disabling and non-disabling) as defined by VARC-2 at 5 years post implantation

  30. Number of Participants With Stroke as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort B

    Time frame: 2 years post implant

    Number of participants with a stroke (disabling and non-disabling) as defined by VARC-2 at 2 years post implantation

  31. Number of Participants With Stroke as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort B

    Time frame: 3 years post implant

    Number of participants with a stroke (disabling and non-disabling) as defined by VARC-2 at 3 years post implantation

  32. Number of Participants With Stroke as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort B

    Time frame: 4 years post implant

    Number of participants with a stroke (disabling and non-disabling) as defined by VARC-2 at 4 years post implantation

  33. Number of Participants With Stroke as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort B

    Time frame: 5 years post implant

    Number of participants with a stroke (disabling and non-disabling) as defined by VARC-2 at 5 years post implantation

  34. Percentage of Participants With Conduction Disturbances and Cardiac Arrythmias as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort A

    Time frame: 30 days post implant

    Percentage of participants with a conduction disturbances and cardiac arrhythmias as defined by VARC-2 at 30 days post implantation

  35. Percentage of Participants With Conduction Disturbances and Cardiac Arrythmias as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort A

    Time frame: 1 year post implant

    Percentage of participants with a conduction disturbances and cardiac arrhythmias as defined by VARC-2 at 1 year post implantation

  36. Percentage of Participants With Conduction Disturbances and Cardiac Arrythmias as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort A

    Time frame: 2 years post implant

    Percentage of participants with a conduction disturbances and cardiac arrhythmias as defined by VARC-2 at 2 years post implantation

  37. Percentage of Participants With Conduction Disturbances and Cardiac Arrythmias as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort A

    Time frame: 3 years post implant

    Percentage of participants with a conduction disturbances and cardiac arrhythmias as defined by VARC-2 at 3 years post implantation

  38. Percentage of Participants With Conduction Disturbances and Cardiac Arrythmias as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort A

    Time frame: 4 years post implant

    Percentage of participants with a conduction disturbances and cardiac arrhythmias as defined by VARC-2 at 4 years post implantation

  39. Percentage of Participants With Conduction Disturbances and Cardiac Arrythmias as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort A

    Time frame: 5 years post implant

    Percentage of participants with a conduction disturbances and cardiac arrhythmias as defined by VARC-2 at 5 years post implantation

  40. Number of Participants With Conduction Disturbances and Cardiac Arrythmias as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort B

    Time frame: 2 years post implant

    Number of participants with a conduction disturbances and cardiac arrhythmias as defined by VARC-2 at 2 years post implantation

  41. Number of Participants With Conduction Disturbances and Cardiac Arrythmias as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort B

    Time frame: 3 years post implant

    Number of participants with a conduction disturbances and cardiac arrhythmias as defined by VARC-2 at 3 years post implantation

  42. Number of Participants With Conduction Disturbances and Cardiac Arrythmias as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort B

    Time frame: 4 years post implant

    Number of participants with a conduction disturbances and cardiac arrhythmias as defined by VARC-2 at 4 years post implantation

  43. Number of Participants With Conduction Disturbances and Cardiac Arrythmias as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort B

    Time frame: 5 years post implant

    Number of participants with a conduction disturbances and cardiac arrhythmias as defined by VARC-2 at 5 years post implantation

  44. Percentage of Participants With Prosthetic Valve Function as Defined by Valve Academic Research Consortium-2 (VARC-2) (Paravalvular Aortic Regurgitation) in Cohort A

    Time frame: 30 days post implant

    Percentage of participants with a paravalvular aortic regurgitation as defined by VARC-2 at 30 days post implantation

  45. Percentage of Participants With Prosthetic Valve Function as Defined by Valve Academic Research Consortium-2 (VARC-2) (Paravalvular Aortic Regurgitation) in Cohort A

    Time frame: 1 year post implant

    Percentage of participants with a paravalvular aortic regurgitation as defined by VARC-2 at 1 year post implantation

  46. Percentage of Participants With Prosthetic Valve Function as Defined by Valve Academic Research Consortium-2 (VARC-2) (Paravalvular Aortic Regurgitation)

    Time frame: 2 years post implant

    Percentage of participants with a paravalvular aortic regurgitation as defined by VARC-2 at 2 years post implantation

  47. Percentage of Participants With Prosthetic Valve Function as Defined by Valve Academic Research Consortium-2 (VARC-2) (Paravalvular Aortic Regurgitation)

    Time frame: 3 years post implant

    Percentage of participants with a paravalvular aortic regurgitation as defined by VARC-2 at 3 years post implantation

  48. Percentage of Participants With Prosthetic Valve Function as Defined by Valve Academic Research Consortium-2 (VARC-2) (Paravalvular Aortic Regurgitation)

    Time frame: 4 years post implant

    Percentage of participants with a paravalvular aortic regurgitation as defined by VARC-2 at 4 years post implantation

  49. Percentage of Participants With Prosthetic Valve Function as Defined by Valve Academic Research Consortium-2 (VARC-2) (Paravalvular Aortic Regurgitation)

    Time frame: 5 years post implant

    Percentage of participants with a paravalvular aortic regurgitation as defined by VARC-2 at 5 years post implantation

Sponsors and collaborators

Lead sponsor

Abbott Medical Devices

Industry

Registry information

Official study title

International Long-term Follow-up Study of Patients Implanted With a Portico™ Valve

Acronym: PORTICO-1

Important dates

Study start
2013
Primary completion
2018
Study completion
2022
First posted
Mar 1, 2013
Registry last updated
Feb 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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