5 Year Observation of Patients With PORTICO Valves

Aortic Valve Stenosis Clinical Trial

— PORTICO-1  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01802788
• Other study ID #: CV-12-054-EU-PV
• Status: Completed
• Start date: April 16, 2013
• Est. completion date: October 19, 2022

Study information

• Verified date: November 2023
• Source: Abbott Medical Devices
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 1032
• Est. completion date: October 19, 2022
• Est. primary completion date: September 25, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aortic Valve Stenosis

Intervention

Device:
• St Jude Medical Portico replacement aortic valve

Procedure:
• Transcatheter Aortic Valve Implant

Locations

Country	Name	City	State
Australia	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
Belgium	AZ Middelheim	Antwerp
Belgium	Cliniques Universitaires Saint-Luc	Bruxelles
Belgium	CHR Citadelle	Liege
Canada	Foothills Medical Centre	Calgary
Canada	Queen Elizabeth II Heath Sciences	Halifax
Canada	Institut de Cardiologie de Montreal (Montreal Heart Inst.)	Montreal
Canada	Ottawa Heart Institute	Ottawa
Canada	Institut de Cardiologie de Quebec (Hospital Laval)	Quebec
Canada	Saint John Regional Hospital - New Brunswick Heart Centre	Saint John
Canada	Toronto General Hospital	Toronto
Canada	St. Paul's Hospital	Vancouver
Denmark	Rigshospitalet	Copenhagen
France	CHRU Hopital de Pontchaillou	Rennes
France	CHU Rangueil Toulouse	Toulouse
France	Clinique Pasteur Toulouse	Toulouse
Germany	Kerckhoff-Klinik gGmbH	Bad Nauheim
Germany	Deutsches Herzzentrum Berlin	Berlin
Germany	Universitatsmedizin Berlin - Campus Benjamin Franklin (CBF)	Berlin
Germany	Immanuelklinikum Bernau und Herzzentrum Brandenburg	Bernau
Germany	St Johannes Hospital	Dortmund
Germany	Herzzentrum Dresden GmbH Universitatsklinik	Dresden
Germany	Klinikum der Johann Wolfgang Goethe-Universitat Frankfurt	Frankfurt
Germany	Universitatsmedizin Gottingen Georg-August-Universitat	Göttingen
Germany	Asklepios Klinikum St Georg	Hamburg
Germany	UKE Hamburg (Universitatsklinik Eppendorf)	Hamburg
Germany	Universitatsklinikum Jena	Jena
Germany	Stadtisches Klinikum Karlsruhe gGmbH Medizinischen Klinik I	Karlsruhe
Germany	Herzzentrum Leipzig GmbH	Leipzig
Germany	Deutsches Herzzentrum Munchen des Freistaates Bayern	Munchen
Israel	Kaplan Medical Center	Re?ovot
Italy	Clinica Citta di Alessandria	Alessandria
Italy	Azienda Ospedali V. Emanuele Ferrarotto E S. Bambino	Catania
Italy	Fondazione Toscana Gabriele Monasterio - Ospedale del Cuore	Massa
Italy	Istituto Sant'Ambrogio	Milan
Italy	Ospedale Niguarda Ca'Granda	Milan
Italy	Ospedale San Raffaele	Milan
Italy	PoliclinicoSan Donato	Milan
Italy	Centro Cardiologico Monzino	Milano
Italy	Policlinico di Monza	Monza
Lithuania	Vilnius University Hospital Santarisku KLinikos	Vilnius
Netherlands	OLVG	Amsterdam
Netherlands	Medisch Centrum Leeuwarden	Leeuwarden
Spain	Hospital de la Santa Creu I Sant Pau	Barcelona
Spain	Hospital Clinico Universitario Virgen de Arrixaca	El Palmar
Spain	Hospital Universitario Virgen Macarena	Sevilla
Switzerland	Universitatspital Spital Zurich	Zurich
United Kingdom	Royal Victoria Hospital	Belfast
United Kingdom	The Royal Sussex Country Hospital	Brighton
United Kingdom	Kings College Hospital	London
United Kingdom	Morriston hospital-ABM University Health Board	Morriston

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Medical Devices

Countries where clinical trial is conducted

Australia,  Belgium,  Canada,  Denmark,  France,  Germany,  Israel,  Italy,  Lithuania,  Netherlands,  Spain,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	30 days through 5 years post implant
Secondary	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.	30 days through 5 years post implant
Secondary	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	30 days through 5 years post implant
Secondary	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.	30 days through 5 years post implant
Secondary	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	30 days through 5 years post implant
Secondary	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.	30 days through 5 years post implant
Secondary	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	30 days through 5 years post implant
Secondary	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	30 days through 5 years post implant
Secondary	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	30 days post implant
Secondary	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	30 days post implant
Secondary	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	30 days post implant
Secondary	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	30 days through 5 years post implant
Secondary	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	30 days through 5 years post implant
Secondary	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
Secondary	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
Secondary	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.	2 years post implant
Secondary	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.	3 years post implant
Secondary	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.	4 years post implant
Secondary	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.	5 years post implant
Secondary	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 through 5 years post implant
Secondary	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'.	30 days and 1 year post implant
Secondary	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	30 days through 5 years post implantation
Secondary	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	30 days through 5 years post implantation
Secondary	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	30 days post implant
Secondary	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	1 year post implant
Secondary	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	2 years post implant
Secondary	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	3 years post implant
Secondary	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	4 years post implant
Secondary	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	5 years post implant
Secondary	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	2 years post implant
Secondary	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	3 years post implant
Secondary	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	4 years post implant
Secondary	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	5 years post implant
Secondary	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	30 days post implant
Secondary	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	1 year post implant
Secondary	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	2 years post implant
Secondary	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	3 years post implant
Secondary	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	4 years post implant
Secondary	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	5 years post implant
Secondary	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	2 years post implant
Secondary	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	3 years post implant
Secondary	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	4 years post implant
Secondary	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	5 years post implant
Secondary	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	30 days post implant
Secondary	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	1 year post implant
Secondary	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	2 years post implant
Secondary	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	3 years post implant
Secondary	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	4 years post implant
Secondary	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	5 years post implant