5 Year Observation of Patients With PORTICO Valves (PORTICO-1)

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

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.

Study Overview

• Status: Completed
• Conditions: Aortic Valve Stenosis
• Intervention / Treatment: Device: St Jude Medical Portico replacement aortic valve; Procedure: Transcatheter Aortic Valve Implant

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.

• Study Type: Observational
• Enrollment (Actual): 1000

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The study population comprises of Cohort A and Cohort B with severe symptomatic aortic stenosis (AS).

Cohort A: Patients enrolled directly into the Portico I study.

Cohort B: Patients implanted in previous SJM-sponsored regulatory (pre-market) investigations and first-in-human trials whom consent for ongoing follow-up in the Portico I study after the completion of their participation in the initial study.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cohort A; Patients implanted with a Portico valve after CE mark	Device: St Jude Medical Portico replacement aortic valve; Procedure: Transcatheter Aortic Valve Implant; Other Names: TAVI; TAVR; Transcatheter Aortic Valve Replacement
Cohort B; Patients implanted in previous SJM-sponsored premarket studies	Device: St Jude Medical Portico replacement aortic valve; Procedure: Transcatheter Aortic Valve Implant; Other Names: TAVI; TAVR; Transcatheter Aortic Valve Replacement

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Abbott Medical Devices
• Investigators: Principal Investigator: Lars Søndergaard, DMSc, Rigshopitalet University Hospital, Copenhagen; Principal Investigator: Francesco Maisano, MD, San Raffaele Hospital; Principal Investigator: Stephen Worthley, St Andrews Hospital; Principal Investigator: Josep Rodes-Cabau, Institut de Cardiologie de Quebec (Hospital Laval)

Publications and helpful links

General Publications

• Sondergaard L, Rodes-Cabau J, Hans-Peter Linke A, Fichtlscherer S, Schafer U, Kuck KH, Kempfert J, Arzamendi D, Bedogni F, Asch FM, Worthley S, Maisano F. Transcatheter Aortic Valve Replacement With a Repositionable Self-Expanding Prosthesis: The PORTICO-I Trial 1-Year Outcomes. J Am Coll Cardiol. 2018 Dec 11;72(23 Pt A):2859-2867. doi: 10.1016/j.jacc.2018.09.014. Epub 2018 Sep 24.

Study record dates

Study Major Dates

• Study Start (Actual): April 16, 2013
• Primary Completion (Actual): September 25, 2018
• Study Completion (Actual): October 19, 2022

Study Registration Dates

• First Submitted: February 21, 2013
• First Submitted That Met QC Criteria: February 28, 2013
• First Posted (Estimated): March 1, 2013

Study Record Updates

• Last Update Posted (Estimated): June 2, 2023
• Last Update Submitted That Met QC Criteria: May 31, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Aortic Stenosis; TAVI; TAVR; Heart Valve Prosthesis; Trans Catheter Aortic Valve Replacement; Trans Catheter Aortic Valve Implant
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Aortic Valve Disease; Heart Valve Diseases; Ventricular Outflow Obstruction; Aortic Valve Stenosis
• Other Study ID Numbers: CV-12-054-EU-PV

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO