5 Year Observation of Patients With PORTICO Valves
- Conditions
- Aortic Valve Stenosis
- Interventions
- Device: St Jude Medical Portico replacement aortic valveProcedure: Transcatheter Aortic Valve Implant
- 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
-
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.
- 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
- Arm && Interventions
Group Intervention Description Cohort A Transcatheter Aortic Valve Implant Patients implanted with a Portico valve after CE mark Cohort A St Jude Medical Portico replacement aortic valve Patients implanted with a Portico valve after CE mark Cohort B Transcatheter Aortic Valve Implant Patients implanted in previous SJM-sponsored premarket studies Cohort B St Jude Medical Portico replacement aortic valve Patients implanted in previous SJM-sponsored premarket studies
- 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)
UKE Hamburg (Universitatsklinik Eppendorf)
🇩🇪Hamburg, Germany
Asklepios Klinikum St Georg
🇩🇪Hamburg, Germany
Azienda Ospedali V. Emanuele Ferrarotto E S. Bambino
🇮🇹Catania, Italy
Istituto Sant'Ambrogio
🇮🇹Milan, Italy
PoliclinicoSan Donato
🇮🇹Milan, Italy
Rigshospitalet
🇩🇰Copenhagen, Denmark
Saint John Regional Hospital - New Brunswick Heart Centre
🇨🇦Saint John, Canada
Queen Elizabeth II Heath Sciences
🇨🇦Halifax, Canada
St. Paul's Hospital
🇨🇦Vancouver, Canada
Kaplan Medical Center
🇮🇱Reẖovot, Israel
Ospedale San Raffaele
🇮🇹Milan, Italy
Hospital de la Santa Creu I Sant Pau
🇪🇸Barcelona, Spain
The Royal Sussex Country Hospital
🇬🇧Brighton, United Kingdom
Kings College Hospital
🇬🇧London, United Kingdom
Royal Victoria Hospital
🇬🇧Belfast, United Kingdom
Vilnius University Hospital Santarisku KLinikos
🇱🇹Vilnius, Lithuania
Medisch Centrum Leeuwarden
🇳🇱Leeuwarden, Netherlands
Hospital Clinico Universitario Virgen de Arrixaca
🇪🇸El Palmar, Spain
Universitatspital Spital Zurich
🇨🇭Zurich, Switzerland
Hospital Universitario Virgen Macarena
🇪🇸Sevilla, Spain
Morriston hospital-ABM University Health Board
🇬🇧Morriston, United Kingdom
St Andrews Hospital
🇦🇺Adelaide, Australia
Royal Adelaide Hospital
🇦🇺Adelaide, Australia
Heart Care Partners-Wesley Hospital
🇦🇺Auchenflower, Australia
The Prince Charles Hospital
🇦🇺Chermside, Australia
The Alfred Hospital
🇦🇺Melbourne, Australia
Royal North Shore hospital
🇦🇺Leonards Hill, 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
AZ Middelheim
🇧🇪Antwerp, Belgium
CHR Citadelle
🇧🇪Liege, Belgium
Cliniques Universitaires Saint-Luc
🇧🇪Bruxelles, Belgium
Institut de Cardiologie de Quebec (Hospital Laval)
🇨🇦Quebec, Canada
Foothills Medical Centre
🇨🇦Calgary, Canada
Institut de Cardiologie de Montreal (Montreal Heart Inst.)
🇨🇦Montreal, Canada
Ottawa Heart Institute
🇨🇦Ottawa, Canada
Toronto General Hospital
🇨🇦Toronto, Canada
CHU Rangueil Toulouse
🇫🇷Toulouse, France
Clinique Pasteur Toulouse
🇫🇷Toulouse, France
CHRU Hopital de Pontchaillou
🇫🇷Rennes, France
Kerckhoff-Klinik gGmbH
🇩🇪Bad Nauheim, Germany
Deutsches Herzzentrum Berlin
🇩🇪Berlin, Germany
Immanuelklinikum Bernau und Herzzentrum Brandenburg
🇩🇪Bernau, Germany
Universitatsmedizin Gottingen Georg-August-Universitat
🇩🇪Göttingen, Germany
Herzzentrum Dresden GmbH Universitatsklinik
🇩🇪Dresden, Germany
St Johannes Hospital
🇩🇪Dortmund, Germany
Klinikum der Johann Wolfgang Goethe-Universitat Frankfurt
🇩🇪Frankfurt, Germany
Universitatsmedizin Berlin - Campus Benjamin Franklin (CBF)
🇩🇪Berlin, Germany
Stadtisches Klinikum Karlsruhe gGmbH Medizinischen Klinik I
🇩🇪Karlsruhe, Germany
Herzzentrum Leipzig GmbH
🇩🇪Leipzig, Germany
Universitatsklinikum Jena
🇩🇪Jena, Germany
Deutsches Herzzentrum Munchen des Freistaates Bayern
🇩🇪Munchen, Germany
Policlinico di Monza
🇮🇹Monza, Italy
OLVG
🇳🇱Amsterdam, Netherlands
Ospedale Niguarda Ca'Granda
🇮🇹Milan, Italy
Clinica Citta di Alessandria
🇮🇹Alessandria, Italy
Fondazione Toscana Gabriele Monasterio - Ospedale del Cuore
🇮🇹Massa, Italy
Centro Cardiologico Monzino
🇮🇹Milano, Italy