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

This study has suspended participant recruitment.
(SJM has suspended TAVR implants to evaluate reports of reduced leaflet mobility.)
Sponsor:
Information provided by (Responsible Party):
St. Jude Medical
ClinicalTrials.gov Identifier:
NCT01802788
First received: February 21, 2013
Last updated: September 17, 2014
Last verified: September 2014
  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 ] [ Designated as safety issue: No ]

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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]

    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. ] [ Designated as safety issue: No ]

    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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: Yes ]
  • 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. ] [ Designated as safety issue: Yes ]
  • 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. ] [ Designated as safety issue: Yes ]
  • 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. ] [ Designated as safety issue: Yes ]
    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. ] [ Designated as safety issue: Yes ]
    • 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. ] [ Designated as safety issue: Yes ]
    • Prosthetic valve stenosis
    • Prosthetic valve regurgitation

  • VARC defined "device success" composite endpoint [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    • 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 ] [ Designated as safety issue: Yes ]
    • 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. ] [ Designated as safety issue: Yes ]
    • 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. ] [ Designated as safety issue: Yes ]
    • 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 ] [ Designated as safety issue: No ]
  • Six minute walk test (6MWT) [ Time Frame: Change between baseline and 30 days, 6 months, 1, 2, 3, 4 and 5 years ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Quality of life is quantified using the EQ-5D-5L questionnaire.


Estimated Enrollment: 1050
Study Start Date: April 2013
Estimated Study Completion Date: December 2020
Estimated Primary Completion Date: December 2016 (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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01802788

Locations
Belgium
Cliniques Universitaires Saint-Luc
Bruxelles, Belgium
Sponsors and Collaborators
St. Jude Medical
Investigators
Principal Investigator: Lars Søndergaard, DMSc Rigshopitalet University Hospital, Copenhagen
Principal Investigator: Francesco Maisano, MD Universitätsspital Zürich
  More Information

No publications provided

Responsible Party: St. Jude Medical
ClinicalTrials.gov Identifier: NCT01802788     History of Changes
Other Study ID Numbers: CV-12-054-EU-PV
Study First Received: February 21, 2013
Last Updated: September 17, 2014
Health Authority: Denmark: Ethics Committee

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

ClinicalTrials.gov processed this record on September 29, 2014