5 Year Observation of Patients With PORTICO Valves

Completed

Conditions: Aortic Valve Stenosis

Registration Number: NCT01802788

Lead Sponsor: Abbott Medical Devices

Brief Summary: 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.

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 1032

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

Study & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With All-cause Mortality	1 year post implant	Percentage of participants that died for any reason at 1 year post implantation

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants With Vascular Access Site Complication as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort A	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
Mean Prosthetic Valve Function as Defined by Valve Academic Research Consortium-2 (VARC-2) (Aortic Valve Area)	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
Mean Quality of Life Assessment in Cohort A	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'.
Percentage of Participants With All Cause Mortality in Cohort A	30 days through 5 years post implant	Percentage of participants that died for any reason at 30 days through 5 years post implantation
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	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.
Percentage of Participants With Myocardial Infarction as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort A	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
Percentage of Participants With Non-Cardiovascular Mortality as Defined by the Valve Academic Research Consortium-2 (VARC-2) in Cohort A	30 days through 5 years post implant	Percentage of participants that died for any reason at 30 days through 5 years post implantation
Percentage of Participants With Bleeding Events as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort A	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
Mean Six Minute Walk Test (6MWT)	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.
Number of Participants With Transient Ischemic Attack in Cohort B	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
Number of Participants With All-cause Mortality (30 Days, Annually From 1 Year Through 5 Years) in Cohort B	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.
Percentage of Participants With Cardiovascular Mortality as Defined by the Valve Academic Research Consortium-2 (VARC-2) in Cohort A	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
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	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.
Number of Participants With Myocardial Infarction as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort B	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
Mean Prosthetic Valve Function as Defined by Valve Academic Research Consortium-2 (VARC-2) (Mean Transvalvular Gradient)	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
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	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
Number of Participants With New York Heart Association (NYHA) Functional Classification of Heart Failure	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.
Percentage of Participants With Transient Ischemic Attack in Cohort A	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
Percentage of Participants With Stroke as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort A	5 years post implant	Percentage of participants with a stroke (disabling and non-disabling) as defined by VARC-2 at 5 years post implantation
Number of Participants With Stroke as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort B	5 years post implant	Number of participants with a stroke (disabling and non-disabling) as defined by VARC-2 at 5 years post implantation
Percentage of Participants With Conduction Disturbances and Cardiac Arrythmias as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort A	5 years post implant	Percentage of participants with a conduction disturbances and cardiac arrhythmias as defined by VARC-2 at 5 years post implantation
Number of Participants With Conduction Disturbances and Cardiac Arrythmias as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort B	5 years post implant	Number of participants with a conduction disturbances and cardiac arrhythmias as defined by VARC-2 at 5 years post implantation
Percentage of Participants With Prosthetic Valve Function as Defined by Valve Academic Research Consortium-2 (VARC-2) (Paravalvular Aortic Regurgitation) in Cohort A	1 year post implant	Percentage of participants with a paravalvular aortic regurgitation as defined by VARC-2 at 1 year post implantation
Percentage of Participants With Prosthetic Valve Function as Defined by Valve Academic Research Consortium-2 (VARC-2) (Paravalvular Aortic Regurgitation)	5 years post implant	Percentage of participants with a paravalvular aortic regurgitation as defined by VARC-2 at 5 years post implantation

Trial Locations

Locations (60): 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
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Royal Adelaide Hospital
🇦🇺Adelaide, Australia