5 Year Observation of Patients With PORTICO Valves

Abbott Medical Devices1,032 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

1,032

Conditions

Aortic Valve Stenosis

Interventions

St Jude Medical Portico replacement aortic valveDEVICE

Transcatheter Aortic Valve ImplantPROCEDURE

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (60)

Outcomes

Primary Outcomes

Percentage of Participants With All-cause Mortality

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

Time frame: 1 year post implant

Secondary Outcomes

Percentage of Participants With All Cause Mortality in Cohort A

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

Time frame: 30 days through 5 years post implant

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

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.

Time frame: 30 days through 5 years post implant

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

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

Time frame: 30 days through 5 years post implant

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

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.

Time frame: 30 days through 5 years post implant

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

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

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Royal Adelaide Hospital

Adelaide, Australia

St Andrews Hospital

Adelaide, Australia

Heart Care Partners-Wesley Hospital

Auchenflower, Australia

The Prince Charles Hospital

Chermside, Australia

Royal North Shore hospital

Leonards Hill, Australia

The Alfred Hospital

Melbourne, Australia

Royal Melbourne Hospital - City Campus

Parkville, Australia

Fiona Stanley Hospital

Perth, Australia

North Shore Private Hospital

St Leonards, Australia

Princess Alexandra Hospital

Woolloongabba, Australia

...and 50 more locations

Time frame: 30 days through 5 years post implant

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

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.

Time frame: 30 days through 5 years post implant

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

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

Time frame: 30 days through 5 years post implant

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

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

Time frame: 30 days through 5 years post implant

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

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

Time frame: 30 days post implant

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

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

Time frame: 30 days post implant

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

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

Time frame: 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 through 5 years post implantation

Time frame: 30 days through 5 years 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 through 5 years post implantation

Time frame: 30 days through 5 years 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.

Time frame: 30 days post implant

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

Time frame: 1 year post implant

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

Time frame: 2 years post implant

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

Time frame: 3 years post implant

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

Time frame: 4 years post implant

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

Time frame: 5 years 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.

Time frame: 30 days through 5 years post implant

Mean Quality of Life Assessment in Cohort A

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'.

Time frame: 30 days and 1 year post implant

Percentage of Participants With Transient Ischemic Attack in Cohort A

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

Time frame: 30 days through 5 years post implantation

Number of Participants With Transient Ischemic Attack in Cohort B

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

Time frame: 30 days through 5 years post implantation

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

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

Time frame: 30 days post implant

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

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

Time frame: 1 year post implant

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

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

Time frame: 2 years post implant

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

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

Time frame: 3 years post implant

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

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

Time frame: 4 years post implant

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

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

Time frame: 5 years post implant

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

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

Time frame: 2 years post implant

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

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

Time frame: 3 years post implant

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

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

Time frame: 4 years post implant

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

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

Time frame: 5 years post implant

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

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

Time frame: 30 days post implant

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

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

Time frame: 1 year post implant

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

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

Time frame: 2 years post implant

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

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

Time frame: 3 years post implant

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

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

Time frame: 4 years post implant

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

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

Time frame: 5 years post implant

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

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

Time frame: 2 years post implant

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

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

Time frame: 3 years post implant

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

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

Time frame: 4 years post implant

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

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

Time frame: 5 years post implant

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

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

Time frame: 30 days post implant

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

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

Time frame: 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 2 years post implantation

Time frame: 2 years 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 3 years post implantation

Time frame: 3 years 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 4 years post implantation

Time frame: 4 years 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 5 years post implantation

Time frame: 5 years post implant