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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01802788
Recruitment Status : Active, not recruiting
First Posted : March 1, 2013
Results First Posted : January 24, 2022
Last Update Posted : May 17, 2022
Sponsor:
Information provided by (Responsible Party):
Abbott Medical Devices

Brief Summary:
This study will further assess the performance and safety profile of the commercially available Portico Valve implanted, using the Delivery System and the Loading System, in patients with severe symptomatic aortic stenosis through 5 years of follow-up.

Condition or disease Intervention/treatment
Aortic Valve Stenosis Device: St Jude Medical Portico replacement aortic valve Procedure: Transcatheter Aortic Valve Implant

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 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.

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Study Type : Observational
Actual Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: International Long-term Follow-up Study of Patients Implanted With a Portico™ Valve
Actual Study Start Date : April 16, 2013
Actual Primary Completion Date : September 25, 2018
Estimated Study Completion Date : September 2022

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Cohort A
Patients implanted with a Portico valve after CE mark
Device: St Jude Medical Portico replacement aortic valve
Procedure: Transcatheter Aortic Valve Implant
Other Names:
  • TAVI
  • Transcatheter Aortic Valve Replacement
  • TAVR

Cohort B
Patients implanted in previous SJM-sponsored premarket studies
Device: St Jude Medical Portico replacement aortic valve
Procedure: Transcatheter Aortic Valve Implant
Other Names:
  • TAVI
  • Transcatheter Aortic Valve Replacement
  • TAVR




Primary Outcome Measures :
  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 Outcome Measures :
  1. Percentage of Participants With All Cause Mortality [ Time Frame: 30 days post implant ]
    Percentage of participants that died for any reason at 30 days post implantation

  2. Percentage of Participants With Cardiovascular Mortality as Defined by the Valve Academic Research Consortium-2 (VARC-2) [ Time Frame: 30 days and 1 year post implant ]
    Percentage of participants that died for cardiovascular or unknown reasons as defined by VARC-2 at 30 days and 1 year post implantation

  3. Percentage of Participants With Myocardial Infarction as Defined by Valve Academic Research Consortium-2 (VARC-2) [ Time Frame: 30 days and 1 year post implant ]
    Percentage of participants with a myocardial infarction as defined by VARC-2 at 30 days and 1 year post implantation

  4. Percentage of Participants With Stroke as Defined by Valve Academic Research Consortium-2 (VARC-2) [ 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

  5. Percentage of Participants With Stroke as Defined by Valve Academic Research Consortium-2 (VARC-2) [ 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

  6. Percentage of Participants With Vascular Access Site Complication as Defined by Valve Academic Research Consortium-2 (VARC-2) [ 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

  7. Percentage of Participants With Bleeding Events as Defined by Valve Academic Research Consortium-2 (VARC-2) [ 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

  8. Percentage of Participants With Stage 2 and 3 Acute Kidney Injury as Defined by Valve Academic Research Consortium-2 (VARC-2) [ Time Frame: 30 days post implant ]
    Percentage of participants with a Stage 2 or Stage 3 acute kidney injury as defined by VARC-2 at 30 days post implantation

  9. Percentage of Participants With Conduction Disturbances and Cardiac Arrythmias as Defined by Valve Academic Research Consortium-2 (VARC-2) [ 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

  10. Mean Prosthetic Valve Function as Defined by Valve Academic Research Consortium-2 (VARC-2) (Aortic Valve Area) [ Time Frame: 30 days post implant ]
    The aortic valve area as interpreted by an independent echocardiographic core laboratory at 30 days post implantation

  11. Mean Prosthetic Valve Function as Defined by Valve Academic Research Consortium-2 (VARC-2) (Aortic Valve Area) [ Time Frame: 1 year post implant ]
    The aortic valve area as interpreted by an independent echocardiographic core laboratory at 1 year post implantation

  12. Mean Prosthetic Valve Function as Defined by Valve Academic Research Consortium-2 (VARC-2) (Mean Transvalvular Gradient) [ Time Frame: 30 days post implant ]
    The mean transvalvular gradient as interpreted by an independent echocardiographic core laboratory at 30 days post implantation

  13. Mean Prosthetic Valve Function as Defined by Valve Academic Research Consortium-2 (VARC-2) (Mean Transvalvular Gradient) [ Time Frame: 1 year post implant ]
    The mean transvalvular gradient as interpreted by an independent echocardiographic core laboratory at 1 year post implantation

  14. Percentage of Participants With Prosthetic Valve Function as Defined by Valve Academic Research Consortium-2 (VARC-2) (Paravalvular Aortic Regurgitation ) [ Time Frame: 30 days post implant ]
    Percentage of participants with a paravalvular aortic regurgitation as defined by VARC-2 at 30 days post implantation

  15. Percentage of Participants With Prosthetic Valve Function as Defined by Valve Academic Research Consortium-2 (VARC-2) (Paravalvular Aortic Regurgitation) [ Time Frame: 1 year post implant ]
    Percentage of participants with a paravalvular aortic regurgitation as defined by VARC-2 at 1 year post implantation

  16. 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.


  17. 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.


  18. Mean Six Minute Walk Test (6MWT) [ Time Frame: 30 days 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.

  19. Mean Six Minute Walk Test (6MWT) [ Time Frame: 1 year 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.

  20. Mean Quality of Life Assessment [ 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'.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

The study population comprises of Cohort A and Cohort B with severe symptomatic aortic stenosis (AS).

Cohort A: Patients enrolled directly into the Portico I study.

Cohort B: Patients implanted in previous SJM-sponsored regulatory (pre-market) investigations and first-in-human trials whom consent for ongoing follow-up in the Portico I study after the completion of their participation in the initial study.

Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01802788


Locations
Show Show 60 study locations
Sponsors and Collaborators
Abbott Medical Devices
Investigators
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Principal Investigator: Lars Søndergaard, DMSc Rigshopitalet University Hospital, Copenhagen
Principal Investigator: Francesco Maisano, MD San Raffaele Hospital
Principal Investigator: Stephen Worthley St Andrews Hospital
Principal Investigator: Josep Rodes-Cabau Institut de Cardiologie de Quebec (Hospital Laval)
  Study Documents (Full-Text)

Documents provided by Abbott Medical Devices:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Abbott Medical Devices
ClinicalTrials.gov Identifier: NCT01802788    
Other Study ID Numbers: CV-12-054-EU-PV
First Posted: March 1, 2013    Key Record Dates
Results First Posted: January 24, 2022
Last Update Posted: May 17, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Abbott Medical Devices:
Aortic Stenosis
Heart Valve Prosthesis
Trans Catheter Aortic Valve Replacement
TAVR
Trans Catheter Aortic Valve Implant
TAVI
Additional relevant MeSH terms:
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Aortic Valve Stenosis
Aortic Valve Disease
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction