Study Results
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View full resultsBasic Information
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COMPLETED
1032 participants
OBSERVATIONAL
2013-04-16
2022-10-19
Brief Summary
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Detailed Description
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The investigation will be conducted at approximately 65 centers in approximately 15 countries in Europe, Middle-East, Africa, Canada, Australia and New Zealand.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Cohort A
Patients implanted with a Portico valve after CE mark
St Jude Medical Portico replacement aortic valve
Transcatheter Aortic Valve Implant
Cohort B
Patients implanted in previous SJM-sponsored premarket studies
St Jude Medical Portico replacement aortic valve
Transcatheter Aortic Valve Implant
Interventions
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St Jude Medical Portico replacement aortic valve
Transcatheter Aortic Valve Implant
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Abbott Medical Devices
INDUSTRY
Responsible Party
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Principal Investigators
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Francesco Maisano, MD
Role: PRINCIPAL_INVESTIGATOR
San Raffaele Hospital
Stephen Worthley
Role: PRINCIPAL_INVESTIGATOR
St Andrews Hospital
Josep Rodes-Cabau
Role: PRINCIPAL_INVESTIGATOR
Institut de Cardiologie de Quebec (Hospital Laval)
Locations
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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
AZ Middelheim
Antwerp, , Belgium
Cliniques Universitaires Saint-Luc
Brussels, , Belgium
CHR Citadelle
Liège, , Belgium
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)
Québec, , Canada
Saint John Regional Hospital - New Brunswick Heart Centre
Saint John, , Canada
Toronto General Hospital
Toronto, , Canada
St. Paul's Hospital
Vancouver, , Canada
Rigshospitalet
Copenhagen, , Denmark
CHRU Hopital de Pontchaillou
Rennes, , France
CHU Rangueil Toulouse
Toulouse, , France
Clinique Pasteur Toulouse
Toulouse, , France
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
München, , Germany
Kaplan Medical Center
Rehovot, , Israel
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
Milan, , Italy
Policlinico di Monza
Monza, , Italy
Vilnius University Hospital Santarisku KLinikos
Vilnius, , Lithuania
OLVG
Amsterdam, , Netherlands
Medisch Centrum Leeuwarden
Leeuwarden, , Netherlands
Hospital de la Santa Creu I Sant Pau
Barcelona, , Spain
Hospital Clinico Universitario Virgen de Arrixaca
El Palmar, , Spain
Hospital Universitario Virgen Macarena
Seville, , Spain
Universitatspital Spital Zurich
Zurich, , Switzerland
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, , United Kingdom
Countries
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References
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Puri R, Thiele H, Fichtlscherer S, Westermann D, Makkar R, Waksman R, Hakmi S, Sondergaard L, Groh M, Montarello JK, Kempfert J, Yong G, Bedogni F, Maisano F, Worthley SG, Rodes-Cabau J, Fontana GP, Mollmann H. Five-Year Clinical Outcomes and Durability of a Self-Expanding Transcatheter Heart Valve With Intra-Annular Leaflets. Circ Cardiovasc Interv. 2025 Oct 24:e015430. doi: 10.1161/CIRCINTERVENTIONS.125.015430. Online ahead of print.
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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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CV-12-054-EU-PV
Identifier Type: -
Identifier Source: org_study_id
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