5 Year Observation of Patients With PORTICO Valves

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Aortic Valve Stenosis

Intervention / Treatment
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* Device: St Jude Medical Portico replacement aortic valve
* Procedure: Transcatheter Aortic Valve Implant


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cohort A<br>Patients implanted with a Portico valve after CE mark | Device: St Jude Medical Portico replacement aortic valve<br> <br> Procedure: Transcatheter Aortic Valve Implant<br> <br> * Other names: TAVR;|
| Cohort B<br>Patients implanted in previous SJM-sponsored premarket studies | Device: St Jude Medical Portico replacement aortic valve<br> <br> Procedure: Transcatheter Aortic Valve Implant<br> <br> * Other names: TAVR;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With All-cause Mortality | Percentage of participants that died for any reason at 1 year post implantation | 1 year post implant | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With All Cause Mortality | Percentage of participants that died for any reason at 30 days post implantation | 30 days post implant | 
| Percentage of Participants With Cardiovascular Mortality as Defined by the Valve Academic Research Consortium-2 (VARC-2) | Percentage of participants that died for cardiovascular or unknown reasons as defined by VARC-2 at 30 days and 1 year post implantation | 30 days and 1 year post implant | 
| Percentage of Participants With Myocardial Infarction as Defined by Valve Academic Research Consortium-2 (VARC-2) | Percentage of participants with a myocardial infarction as defined by VARC-2 at 30 days and 1 year post implantation | 30 days and 1 year post implant | 
| Percentage of Participants With Stroke as Defined by Valve Academic Research Consortium-2 (VARC-2) | Percentage of participants with a stroke (disabling and non-disabling) as defined by VARC-2 at 30 days post implantation | 30 days post implant | 
| Percentage of Participants With Stroke as Defined by Valve Academic Research Consortium-2 (VARC-2) | Percentage of participants with a stroke (disabling and non-disabling) as defined by VARC-2 at 1 year post implantation | 1 year post implant | 
| Percentage of Participants With Vascular Access Site Complication as Defined by Valve Academic Research Consortium-2 (VARC-2) | Percentage of participants with vascular access site complication (major or minor) as defined by VARC-2 at 30 days post implantation | 30 days post implant | 
| Percentage of Participants With Bleeding Events as Defined by Valve Academic Research Consortium-2 (VARC-2) | Percentage of participants with a bleeding events (life threatening, major or minor) as defined by VARC-2 at 30 days post implantation | 30 days post implant | 
| Percentage of Participants With Stage 2 and 3 Acute Kidney Injury as Defined by Valve Academic Research Consortium-2 (VARC-2) | Percentage of participants with a Stage 2 or Stage 3 acute kidney injury as defined by VARC-2 at 30 days post implantation | 30 days post implant | 
| Percentage of Participants With Conduction Disturbances and Cardiac Arrythmias as Defined by Valve Academic Research Consortium-2 (VARC-2) | Percentage of participants with a conduction disturbances and cardiac arrhythmias as defined by VARC-2 at 30 days post implantation | 30 days post implant | 
| Mean Prosthetic Valve Function as Defined by Valve Academic Research Consortium-2 (VARC-2) (Aortic Valve Area) | The aortic valve area as interpreted by an independent echocardiographic core laboratory at 30 days post implantation | 30 days post implant | 
| Mean Prosthetic Valve Function as Defined by Valve Academic Research Consortium-2 (VARC-2) (Aortic Valve Area) | The aortic valve area as interpreted by an independent echocardiographic core laboratory at 1 year post implantation | 1 year post implant | 
| Mean Prosthetic Valve Function as Defined by Valve Academic Research Consortium-2 (VARC-2) (Mean Transvalvular Gradient) | The mean transvalvular gradient as interpreted by an independent echocardiographic core laboratory at 30 days post implantation | 30 days post implant | 
| Mean Prosthetic Valve Function as Defined by Valve Academic Research Consortium-2 (VARC-2) (Mean Transvalvular Gradient) | The mean transvalvular gradient as interpreted by an independent echocardiographic core laboratory at 1 year post implantation | 1 year post implant | 
| Percentage of Participants With Prosthetic Valve Function as Defined by Valve Academic Research Consortium-2 (VARC-2) (Paravalvular Aortic Regurgitation ) | Percentage of participants with a paravalvular aortic regurgitation as defined by VARC-2 at 30 days post implantation | 30 days post implant | 
| Percentage of Participants With Prosthetic Valve Function as Defined by Valve Academic Research Consortium-2 (VARC-2) (Paravalvular Aortic Regurgitation) | Percentage of participants with a paravalvular aortic regurgitation as defined by VARC-2 at 1 year post implantation | 1 year post implant | 
| Number of Participants With New York Heart Association (NYHA) Functional Classification of Heart Failure | 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. | 30 days post implant | 
| Number of Participants With New York Heart Association (NYHA) Functional Classification of Heart Failure | 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. | 1 year post implant | 
| Mean Six Minute Walk Test (6MWT) | 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. | 30 days post implant | 
| Mean Six Minute Walk Test (6MWT) | 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. | 1 year post implant | 
| Mean Quality of Life Assessment | 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'. | 30 days and 1 year post implant | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Aortic Stenosis, Heart Valve Prosthesis, Trans Catheter Aortic Valve Replacement, TAVR, Trans Catheter Aortic Valve Implant, TAVI