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Trial record 2 of 11 for:    portico

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

This study is currently recruiting participants.
Verified November 2016 by St. Jude Medical
Sponsor:
ClinicalTrials.gov Identifier:
NCT01802788
First Posted: March 1, 2013
Last Update Posted: November 25, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
St. Jude Medical
  Purpose
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.

Condition Intervention
Aortic Valve Stenosis Device: St Jude Medical Portico replacement aortic valve Procedure: Transcatheter Aortic Valve Implant

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: International Long-term Follow-up Study of Patients Implanted With a Portico™ Valve

Resource links provided by NLM:


Further study details as provided by St. Jude Medical:

Primary Outcome Measures:
  • All-cause Mortality [ Time Frame: 1 year ]

Secondary Outcome Measures:
  • All Cause Mortality [ Time Frame: 30 days, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years post device implant. ]
  • Frequency of Cardiovascular Mortality as defined by the Valve Academic Research Consortium (VARC) [ Time Frame: 30 days, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years post device implant. ]

    Any one of the following criteria:

    • Death due to proximate cardiac cause (e.g., myocardial infarction, cardiac tamponade, worsening heart failure).
    • Death caused by non-coronary vascular conditions such as neurological events, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular disease.
    • All procedure-related deaths, including those related to a complication of the procedure or treatment for a complication of the procedure.
    • All valve-related deaths including structural or non-structural valve dysfunction or other valve-related adverse event.
    • Sudden or witnessed death.
    • Death of unknown cause.

  • Frequency of Myocardial Infarction as defined by VARC [ Time Frame: 30 days, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years post device implant. ]

    Please refer to the following publication for a detailed description of this and all further VARC defined endpoints:

    Kappetein AP, Head SJ, Généreux P, et al. Updated standardized endpoint definitions for transcatheter aortic valve implantation: The Valve Academic Research Consortium-2 consensus document. The Journal of Thoracic and Cardiovascular Surgery 2013;145(1):6-23.


  • Frequency of Stroke as defined by VARC. [ Time Frame: 30 days, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years post device implant. ]
  • Frequency of Bleeding events as defined by VARC. [ Time Frame: 30 days, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years post device implant. ]
  • Frequency of Acute Kidney injury as defined by VARC [ Time Frame: 30 days, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years post device implant. ]
  • Frequency of Vascular and access related complications as defined by VARC [ Time Frame: 30 days, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years post device implant. ]
  • Frequency of Conduction disturbances and cardiac arrythmias as defined by VARC. [ Time Frame: 30 days, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years post device implant. ]
    In particular this includes the rate of pacemaker implantation at 30 days post procedure

  • Frequency of other TAVI related complications as defined by VARC. [ Time Frame: 30 days, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years post device implant. ]
    • Conversion to open surgery
    • Unplanned use of cardiopulmonary bypass (CPB)
    • Coronary obstruction
    • Ventricular septal perforation
    • Mitral valve apparatus damage or dysfunction
    • Cardiac tamponade
    • Endocarditis
    • Valve thrombosis
    • Valve malpositioning
    • Transcatheter valve in Transcatheter valve deployment

  • Prosthetic valve function as defined by VARC [ Time Frame: 30 days, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years post device implant. ]
    • Prosthetic valve stenosis
    • Prosthetic valve regurgitation

  • VARC defined "device success" composite endpoint [ Time Frame: 30 days ]
    • Absence of procedural mortality AND
    • Correct positioning of a single prosthetic heart valve into the proper anatomical location AND
    • Intended performance of the prosthetic heart valve (no prosthesis-patient mismatch and mean aortic valve gradient <20 mmHg or peak velocity <3 m/s, AND no moderate or severe prosthetic valve regurgitation)

  • VARC defined "Early Safety" composite endpoint [ Time Frame: 30 days ]
    • All-cause mortality
    • All stroke (disabling and non-disabling)
    • Life-threatening bleeding
    • Acute kidney injury—Stage 2 or 3 (including renal replacement therapy)
    • Coronary artery obstruction requiring intervention
    • Major vascular complication
    • Valve-related dysfunction requiring repeat procedure (Balloon Aortic Valvuloplasty (BAV), Trans Catheter Aortic Valve Implant (TAVI), or Surgical Aortic Valve Replacement (SAVR))

  • VARC defined "Clinical Efficacy" composite endpoint [ Time Frame: From 30 days post procedure to completion of follow up at 5 years. ]
    • All-cause mortality
    • All stroke (disabling and non-disabling)
    • Requiring hospitalizations for valve-related symptoms or worsening congestive heart failure
    • NYHA (New york Heart Association) class III or IV functional classification of heart failure.
    • Valve-related dysfunction (mean aortic valve gradient ≥20 mmHg, Effective Orifice Area (EOA) ≤0.9-1.1 cm2(c) and/or Doppler Velocity Integral (DVI) <0. 35 m/s, AND/OR moderate or severe prosthetic valve regurgitation.

  • VARC defined "Time-related valve safety" composite endpoint [ Time Frame: From device implant to completion of follow up at 5 years. ]
    • Structural valve deterioration
    • Valve-related dysfunction (mean aortic valve gradient
    • ≥20 mmHg, EOA ≤0.9-1.1 cm2cand/or DVI <0.35 m/s, AND/OR moderate or severe prosthetic valve regurgitation)
    • Requiring repeat procedure (TAVI or SAVR)
    • Prosthetic valve endocarditis
    • Prosthetic valve thrombosis
    • Thrombo-embolic events (e.g. stroke)
    • VARC bleeding, unless clearly unrelated to valve therapy (e.g. trauma)

  • New York Heart Association (NYHA) Functional classification of heart failure. [ Time Frame: Change in NYHA class between baseline and 30 days, 6 months, 1, 2, 3, 4 and 5 years ]
  • Six minute walk test (6MWT) [ Time Frame: Change between baseline and 30 days, 6 months, 1, 2, 3, 4 and 5 years ]
    Distance in metres that the participant can walk in 6 minutes.

  • Quality of Life Assessment. [ Time Frame: Change in Quality of Life from Baseline to 30 days, 6 months, 1, 2, 3, 4 and 5 years ]
    Quality of life is quantified using the EQ-5D-5L questionnaire.


Estimated Enrollment: 1050
Study Start Date: April 2013
Estimated Study Completion Date: August 2022
Estimated Primary Completion Date: May 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Cohort A
Patients implanted with a Portico valve bearing the CE mark (implanted after St Jude Medical declared the device "compliant" with all applicable essential requirements within the European union and marketed the device bearing the CE mark.)
Device: St Jude Medical Portico replacement aortic valve Procedure: Transcatheter Aortic Valve Implant
Other Names:
  • TAVI
  • Transcatheter Aortic Valve Replacement
  • TAVR
Cohort B
Patients implanted with a Portico valve as part of an Investigational Device study.
Device: St Jude Medical Portico replacement aortic valve Procedure: Transcatheter Aortic Valve Implant
Other Names:
  • TAVI
  • Transcatheter Aortic Valve Replacement
  • TAVR

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients that are candidates for implantation of a St Jude Medical Portico replacement aortic heart valve, or have been implanted with with a St. Jude Medical Portico valve as part of a previous investigational device trial
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.
  • Patient has senile degenerative aortic stenosis with an initial valve area of less than (<) 1.0 cm2 (or aortic valve area index less than or equal to (≤) 0.6 cm2/m2) AND a mean transvalvular gradient greater than (>) 40mmHg or jet velocity greater than (>) 4.0 m/s derived by resting echocardiogram [or dobutamine stress echocardiogram if subject has a left ventricular ejection fraction (LVEF) < 50%]. (Baseline measurement taken by echo within 45 days of index procedure).
  • Patient has a life expectancy more than (>) 12 months.

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 than tricuspid valve.
  • 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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01802788


Contacts
Contact: Mariella Van Ransbeeck +322 774 68 29 mvanransbeeck@sjm.com
Contact: Angelic Roach +1 651 7563379 ARoach@sjm.com

  Hide Study Locations
Locations
Australia
Royal Adelaide Hospital Recruiting
Adelaide, Australia
Contact: Joseph Montarello         
St Andrews Hospital Recruiting
Adelaide, Australia
Contact: Stephen Worthley         
Heart Care Partners-Wesley Hospital Recruiting
Auchenflower, Australia
Contact: Anthony Rafter         
The Prince Charles Hospital Recruiting
Chermside, Australia
Contact: Darren Walters         
Royal North Shore hospital Active, not recruiting
Leonards Hill, Australia
The Alfred Hospital Recruiting
Melbourne, Australia
Contact: Tony Walton         
Royal Melbourne Hospital - City Campus Recruiting
Parkville, Australia
Contact: Gurvitch Ronen         
Fiona Stanley Hospital Recruiting
Perth, Australia
Contact: Gerald Yong         
Royal North Shore Hospital Recruiting
St Leonards, Australia
Contact: Ravinay Bhindi         
Princess Alexandra Hospital Recruiting
Woolloongabba, Australia
Contact: Camuglia, MD         
Belgium
Cliniques Universitaires Saint-Luc Recruiting
Bruxelles, Belgium
Contact: Joelle Kefer, MD    +32 2 764 28 12      
Principal Investigator: Joelle Kefer, MD         
CHR Citadelle Active, not recruiting
Liege, Belgium
ZNA Middleheim Active, not recruiting
Middleheim, Belgium
Canada
Foothills Recruiting
Calgary, Canada
Contact: Al-Qoofi, MD         
Queen Elizabeth Heath Sciences Active, not recruiting
Halifax, Canada
Institut de Cardiologie de Montreal (Montreal Heart Inst.) Recruiting
Montreal, Canada
Contact: Anita Asgar         
Ottawa Heart Institute Active, not recruiting
Ottawa, Canada
Institut de Cardiologie de Quebec (Hospital Laval) Recruiting
Quebec, Canada
Contact: Josep Rodes-Cabau,         
Saint John Regional Hospital - New Brunswick Heart Centre Recruiting
Saint John, Canada
Contact: Marc Pelletier         
Toronto General Hospital Active, not recruiting
Torontp, Canada
St. Paul's Hospital Recruiting
Vancouver, Canada
Contact: John Webb         
Denmark
Rigshospitalet Recruiting
Copenhagen, Denmark
Contact: Lars Sondergaard         
Germany
Kerckhoff-Klinik Recruiting
Bad Nauheim, Germany
Contact: Kim Won-Keun         
Deutsches Herzzentrum Berlin Recruiting
Berlin, Germany
Contact: Joerg Kempfert         
Universitätsmedizn Berlin - Campus Benjamin Recruiting
Berlin, Germany
Contact: Alexander Lauten         
Herzzentrum Brandenburg Evangelisches Freikirchliches Krankenhaus - Herzchirurgie Recruiting
Bernau, Germany
Contact: Christian Butter         
Klinikum Bremen Links-der-Weser Active, not recruiting
Bremen, Germany
St Johannes Hospital Active, not recruiting
Dortmund, Germany
Herzzentrum Dresden Recruiting
Dresden, Germany
Contact: Strasser, MD         
Universität Frankfurt Recruiting
Frankfurt, Germany
Contact: Fichtlscherer, MD         
Herzzentrum Göttingen der Georg-August-Universität Recruiting
Göttingen, Germany
Contact: Claudius Jabobshagen         
Asklepios Klinikum St Georg Recruiting
Hamburg, Germany
Contact: Karl-Heinz Kuck         
UKE Hamburg (Universitatsklinik Eppendorf) Recruiting
Hamburg, Germany
Contact: Ulrich Schaefer         
Klinikum der Friedrich Schiller Universität Jena Recruiting
Jena, Germany
Contact: Lauten         
Städtisches Klinikum Karlsruhe, Klinik für Innere Medizin IV Recruiting
Karlsruhe, Germany
Contact: Gerhardt Schymik         
Herzzentrum Leipzig Recruiting
Leipzig, Germany
Contact: Axel Hans-Peter Linke         
Deutsches Herzzentrum Recruiting
Munchen, Germany
Contact: Mazzitelli, MD         
Italy
Clinica Citta di Alessandria Recruiting
Alessandria, Italy
Contact: Cioffi, MD         
Azienda Ospedali V. Emanuele Ferrarotto E S. Bambino Recruiting
Catania, Italy
Contact: Corrado Tamburino         
Fondazione Toscana Gabriele Monasterio - Ospedale del Cuore Recruiting
Massa, Italy
Contact: Sergio Berti         
Centro Cardiologico Monzino Recruiting
Milano, Italy
Contact: Bartorelli, MD         
Istituto Sant'Ambrogio Recruiting
Milan, Italy
Contact: Massimo Meddi         
Ospedale San Raffaele Recruiting
Milan, Italy
Contact: Antonio Colombo         
PoliclinicoSan Donato Recruiting
Milan, Italy
Contact: Francesco Bedogni         
Policlinico di Monza Recruiting
Monza, Italy
Contact: Scalise, MD         
Netherlands
OLVG Recruiting
Amsterdam, Netherlands
Contact: Amoroso, MD         
Medisch Centrum Leeuwarden Recruiting
Leeuwarden, Netherlands
Contact: Ad Van Boven         
Erasmus MC - Thoraxcenter Terminated
Rotterdam, Netherlands
Spain
Hospital de la Santa Creu I Sant Pau Recruiting
Barcelona, Spain
Contact: Serra, MD         
Hospital Universitario Virgen de Arrixaca Recruiting
El Palmar, Spain
Contact: Valdes, MD         
Hospital Universitario Virgen Macarena Active, not recruiting
Sevilla, Spain
Switzerland
Universitatspital Zurich Recruiting
Zurich, Switzerland
Contact: Francesco Maisano, Prof         
United Kingdom
The Royal Sussex Country Hospital Recruiting
Brighton, United Kingdom
Contact: David Hildick-Smith         
King's College Not yet recruiting
London, United Kingdom
Contact: Wendler, MD         
Morriston hospital-ABM University Health Board Recruiting
Morriston, United Kingdom
Contact: Dave Smith         
Sponsors and Collaborators
St. Jude Medical
Investigators
Principal Investigator: Lars Søndergaard, DMSc Rigshopitalet University Hospital, Copenhagen
Principal Investigator: Francesco Maisano, MD Universitätsspital Zürich
Principal Investigator: Stephen Worthley St Andrews Hospital
Principal Investigator: Josep Rodes-Cabau Institut de Cardiologie de Quebec (Hospital Laval)
  More Information

Responsible Party: St. Jude Medical
ClinicalTrials.gov Identifier: NCT01802788     History of Changes
Other Study ID Numbers: CV-12-054-EU-PV
First Submitted: February 21, 2013
First Posted: March 1, 2013
Last Update Posted: November 25, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by St. Jude Medical:
Aortic Stenosis
Heart Valve Prosthesis
Trans Catheter Aortic Valve Replacement
TAVR
Trans Catheter Aortic Valve Implant
TAVI

Additional relevant MeSH terms:
Aortic Valve Stenosis
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction