Clinical trial NCT01802788: 5 Year Observation of Patients With PORTICO Valves
Official title: International Long-term Follow-up Study of Patients Implanted With a Portico™ Valve
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Aortic Valve Stenosis
Keywords: Aortic Stenosis
CV-12-054-EU-PV
Heart Valve Prosthesis
Trans Catheter Aortic Valve Replacement
TAVR
Trans Catheter Aortic Valve Implant
TAVI
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2013-03-01
Enrollment: 1032
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Participants With All-cause Mortality
timeFrame: 1 year post implant
Secondary outcomes:
measure: Percentage of Participants With All Cause Mortality in Cohort A
timeFrame: 30 days through 5 years post implant
measure: Number of Participants With All-cause Mortality (30 Days, Annually From 1 Year Through 5 Years) in Cohort B
timeFrame: 30 days through 5 years post implant
measure: Percentage of Participants With Cardiovascular Mortality as Defined by the Valve Academic Research Consortium-2 (VARC-2) in Cohort A
timeFrame: 30 days through 5 years post implant
measure: 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
timeFrame: 30 days through 5 years post implant
measure: Percentage of Participants With Non-Cardiovascular Mortality as Defined by the Valve Academic Research Consortium-2 (VARC-2) in Cohort A
timeFrame: 30 days through 5 years post implant
measure: 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
timeFrame: 30 days through 5 years post implant
measure: Percentage of Participants With Myocardial Infarction as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort A
timeFrame: 30 days through 5 years post implant
measure: Number of Participants With Myocardial Infarction as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort B
timeFrame: 30 days through 5 years post implant
measure: Percentage of Participants With Vascular Access Site Complication as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort A
timeFrame: 30 days post implant
measure: Percentage of Participants With Bleeding Events as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort A
timeFrame: 30 days post implant
measure: 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
timeFrame: 30 days post implant
measure: Mean Prosthetic Valve Function as Defined by Valve Academic Research Consortium-2 (VARC-2) (Aortic Valve Area)
timeFrame: 30 days through 5 years post implant
measure: Mean Prosthetic Valve Function as Defined by Valve Academic Research Consortium-2 (VARC-2) (Mean Transvalvular Gradient)
timeFrame: 30 days through 5 years post implant
measure: Number of Participants With New York Heart Association (NYHA) Functional Classification of Heart Failure
timeFrame: 30 days post implant
measure: Number of Participants With New York Heart Association (NYHA) Functional Classification of Heart Failure
timeFrame: 1 year post implant
measure: Number of Participants With New York Heart Association (NYHA) Functional Classification of Heart Failure
timeFrame: 2 years post implant
measure: Number of Participants With New York Heart Association (NYHA) Functional Classification of Heart Failure
timeFrame: 3 years post implant
measure: Number of Participants With New York Heart Association (NYHA) Functional Classification of Heart Failure
timeFrame: 4 years post implant
measure: Number of Participants With New York Heart Association (NYHA) Functional Classification of Heart Failure
timeFrame: 5 years post implant
measure: Mean Six Minute Walk Test (6MWT)
timeFrame: 30 days through 5 years post implant
measure: Mean Quality of Life Assessment in Cohort A
timeFrame: 30 days and 1 year post implant
measure: Percentage of Participants With Transient Ischemic Attack in Cohort A
timeFrame: 30 days through 5 years post implantation
measure: Number of Participants With Transient Ischemic Attack in Cohort B
timeFrame: 30 days through 5 years post implantation
measure: Percentage of Participants With Stroke as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort A
timeFrame: 30 days post implant
measure: Percentage of Participants With Stroke as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort A
timeFrame: 1 year post implant
measure: Percentage of Participants With Stroke as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort A
timeFrame: 2 years post implant
measure: Percentage of Participants With Stroke as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort A
timeFrame: 3 years post implant
measure: Percentage of Participants With Stroke as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort A
timeFrame: 4 years post implant
measure: Percentage of Participants With Stroke as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort A
timeFrame: 5 years post implant
measure: Number of Participants With Stroke as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort B
timeFrame: 2 years post implant
measure: Number of Participants With Stroke as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort B
timeFrame: 3 years post implant
measure: Number of Participants With Stroke as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort B
timeFrame: 4 years post implant
measure: Number of Participants With Stroke as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort B
timeFrame: 5 years post implant
measure: Percentage of Participants With Conduction Disturbances and Cardiac Arrythmias as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort A
timeFrame: 30 days post implant
measure: Percentage of Participants With Conduction Disturbances and Cardiac Arrythmias as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort A
timeFrame: 1 year post implant
measure: Percentage of Participants With Conduction Disturbances and Cardiac Arrythmias as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort A
timeFrame: 2 years post implant
measure: Percentage of Participants With Conduction Disturbances and Cardiac Arrythmias as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort A
timeFrame: 3 years post implant
measure: Percentage of Participants With Conduction Disturbances and Cardiac Arrythmias as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort A
timeFrame: 4 years post implant
measure: Percentage of Participants With Conduction Disturbances and Cardiac Arrythmias as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort A
timeFrame: 5 years post implant
measure: Number of Participants With Conduction Disturbances and Cardiac Arrythmias as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort B
timeFrame: 2 years post implant
measure: Number of Participants With Conduction Disturbances and Cardiac Arrythmias as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort B
timeFrame: 3 years post implant
measure: Number of Participants With Conduction Disturbances and Cardiac Arrythmias as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort B
timeFrame: 4 years post implant
measure: Number of Participants With Conduction Disturbances and Cardiac Arrythmias as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort B
timeFrame: 5 years post implant
measure: Percentage of Participants With Prosthetic Valve Function as Defined by Valve Academic Research Consortium-2 (VARC-2) (Paravalvular Aortic Regurgitation) in Cohort A
timeFrame: 30 days post implant
measure: Percentage of Participants With Prosthetic Valve Function as Defined by Valve Academic Research Consortium-2 (VARC-2) (Paravalvular Aortic Regurgitation) in Cohort A
timeFrame: 1 year post implant
measure: Percentage of Participants With Prosthetic Valve Function as Defined by Valve Academic Research Consortium-2 (VARC-2) (Paravalvular Aortic Regurgitation)
timeFrame: 2 years post implant
measure: Percentage of Participants With Prosthetic Valve Function as Defined by Valve Academic Research Consortium-2 (VARC-2) (Paravalvular Aortic Regurgitation)
timeFrame: 3 years post implant
measure: Percentage of Participants With Prosthetic Valve Function as Defined by Valve Academic Research Consortium-2 (VARC-2) (Paravalvular Aortic Regurgitation)
timeFrame: 4 years post implant
measure: Percentage of Participants With Prosthetic Valve Function as Defined by Valve Academic Research Consortium-2 (VARC-2) (Paravalvular Aortic Regurgitation)
timeFrame: 5 years post implant
Other outcomes:
Locations:
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital
city: Adelaide
country: Australia
facility: St Andrews Hospital
city: Auchenflower
country: Australia
facility: Heart Care Partners-Wesley Hospital
city: Chermside
country: Australia
facility: The Prince Charles Hospital
city: Leonards Hill
country: Australia
facility: Royal North Shore hospital
city: Melbourne
country: Australia
facility: The Alfred Hospital
city: Parkville
country: Australia
facility: Royal Melbourne Hospital - City Campus
city: Perth
country: Australia
facility: Fiona Stanley Hospital
city: St Leonards
country: Australia
facility: North Shore Private Hospital
city: Woolloongabba
country: Australia
facility: Princess Alexandra Hospital
city: Antwerp
country: Belgium
facility: AZ Middelheim
city: Bruxelles
country: Belgium
facility: Cliniques Universitaires Saint-Luc
city: Liege
country: Belgium
facility: CHR Citadelle
city: Calgary
country: Canada
facility: Foothills Medical Centre
city: Halifax
country: Canada
facility: Queen Elizabeth II Heath Sciences
city: Montreal
country: Canada
facility: Institut de Cardiologie de Montreal (Montreal Heart Inst.)
city: Ottawa
country: Canada
facility: Ottawa Heart Institute
city: Quebec
country: Canada
facility: Institut de Cardiologie de Quebec (Hospital Laval)
city: Saint John
country: Canada
facility: Saint John Regional Hospital - New Brunswick Heart Centre
city: Toronto
country: Canada
facility: Toronto General Hospital
city: Vancouver
country: Canada
facility: St. Paul's Hospital
city: Copenhagen
country: Denmark
facility: Rigshospitalet
city: Rennes
country: France
facility: CHRU Hopital de Pontchaillou
city: Toulouse
country: France
facility: CHU Rangueil Toulouse
city: Toulouse
country: France
facility: Clinique Pasteur Toulouse
city: Bad Nauheim
country: Germany
facility: Kerckhoff-Klinik gGmbH
city: Berlin
country: Germany
facility: Deutsches Herzzentrum Berlin
city: Berlin
country: Germany
facility: Universitatsmedizin Berlin - Campus Benjamin Franklin (CBF)
city: Bernau
country: Germany
facility: Immanuelklinikum Bernau und Herzzentrum Brandenburg
city: Dortmund
country: Germany
facility: St Johannes Hospital
city: Dresden
country: Germany
facility: Herzzentrum Dresden GmbH Universitatsklinik
city: Frankfurt
country: Germany
facility: Klinikum der Johann Wolfgang Goethe-Universitat Frankfurt
city: Göttingen
country: Germany
facility: Universitatsmedizin Gottingen Georg-August-Universitat
city: Hamburg
country: Germany
facility: Asklepios Klinikum St Georg
city: Hamburg
country: Germany
facility: UKE Hamburg (Universitatsklinik Eppendorf)
city: Jena
country: Germany
facility: Universitatsklinikum Jena
city: Karlsruhe
country: Germany
facility: Stadtisches Klinikum Karlsruhe gGmbH Medizinischen Klinik I
city: Leipzig
country: Germany
facility: Herzzentrum Leipzig GmbH
city: Munchen
country: Germany
facility: Deutsches Herzzentrum Munchen des Freistaates Bayern
city: Reẖovot
country: Israel
facility: Kaplan Medical Center
city: Alessandria
country: Italy
facility: Clinica Citta di Alessandria
city: Catania
country: Italy
facility: Azienda Ospedali V. Emanuele Ferrarotto E S. Bambino
city: Massa
country: Italy
facility: Fondazione Toscana Gabriele Monasterio - Ospedale del Cuore
city: Milano
country: Italy
facility: Centro Cardiologico Monzino
city: Milan
country: Italy
facility: Istituto Sant'Ambrogio
city: Milan
country: Italy
facility: Ospedale Niguarda Ca'Granda
city: Milan
country: Italy
facility: Ospedale San Raffaele
city: Milan
country: Italy
facility: PoliclinicoSan Donato
city: Monza
country: Italy
facility: Policlinico di Monza
city: Vilnius
country: Lithuania
facility: Vilnius University Hospital Santarisku KLinikos
city: Amsterdam
country: Netherlands
facility: OLVG
city: Leeuwarden
country: Netherlands
facility: Medisch Centrum Leeuwarden
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu I Sant Pau
city: El Palmar
country: Spain
facility: Hospital Clinico Universitario Virgen de Arrixaca
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Macarena
city: Zurich
country: Switzerland
facility: Universitatspital Spital Zurich
city: Belfast
country: United Kingdom
facility: Royal Victoria Hospital
city: Brighton
country: United Kingdom
facility: The Royal Sussex Country Hospital
city: London
country: United Kingdom
facility: Kings College Hospital
city: Morriston
country: United Kingdom
facility: Morriston hospital-ABM University Health Board
Study officials:
affiliation: San Raffaele Hospital
name: Francesco Maisano, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: St Andrews Hospital
name: Stephen Worthley
role: PRINCIPAL_INVESTIGATOR
affiliation: Institut de Cardiologie de Quebec (Hospital Laval)
name: Josep Rodes-Cabau
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.