ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01802788
Recruitment Status : Active, not recruiting
First Posted : March 1, 2013
Last Update Posted : April 20, 2018
Sponsor:
Information provided by (Responsible Party):
St. Jude Medical

February 21, 2013
March 1, 2013
April 20, 2018
April 2013
August 2018   (Final data collection date for primary outcome measure)
All-cause Mortality [ Time Frame: 1 year ]
Death rate for any reason at 1 year
All-cause Mortality [ Time Frame: 1 year ]
Complete list of historical versions of study NCT01802788 on ClinicalTrials.gov Archive Site
  • All Cause Mortality [ Time Frame: 30 days, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years post device implant. ]
    Death rate for any reason at specified times
  • 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. ]
    Rate of stroke at each time point according to the Valve Academic Research Consortium definitions.
  • 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. ]
    Rate of minor, major and life threatening bleeding events at each time point according to the Valve Academic Research Consortium definitions.
  • 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. ]
    Rate of AKI at each time point according to the Valve Academic Research Consortium definitions.
  • 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. ]
    Rate of major and minor VASC events at each time point according to the Valve Academic Research Consortium definitions.
  • 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: 30 days, 6 months, 1, 2, 3, 4 and 5 years ]
    Change in NYHA class between baseline and each follow-up
  • 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.
  • 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 failureb
    • 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 regurgitationa
  • 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 regurgitationa)
    • 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.
Not Provided
Not Provided
 
5 Year Observation of Patients With PORTICO Valves
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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
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
Aortic Valve Stenosis
  • Device: St Jude Medical Portico replacement aortic valve
  • Procedure: Transcatheter Aortic Valve Implant
    Other Names:
    • TAVI
    • Transcatheter Aortic Valve Replacement
    • TAVR
  • 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.)
    Interventions:
    • Device: St Jude Medical Portico replacement aortic valve
    • Procedure: Transcatheter Aortic Valve Implant
  • Cohort B
    Patients implanted with a Portico valve as part of an Investigational Device study.
    Interventions:
    • Device: St Jude Medical Portico replacement aortic valve
    • Procedure: Transcatheter Aortic Valve Implant
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
1050
Same as current
August 2022
August 2018   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Australia,   Belgium,   Canada,   Denmark,   Germany,   Italy,   Netherlands,   Spain,   Switzerland,   United Kingdom
 
 
NCT01802788
CV-12-054-EU-PV
Yes
Not Provided
Plan to Share IPD: No
St. Jude Medical
St. Jude Medical
Not Provided
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)
St. Jude Medical
April 2018