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Trial record 4 of 15 for:    portico

Assessment of the St Jude Medical Portico Resheathable Aortic Valve System-Alternative Access (Portico ALT)

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ClinicalTrials.gov Identifier: NCT03056573
Recruitment Status : Recruiting
First Posted : February 17, 2017
Last Update Posted : April 20, 2018
Sponsor:
Information provided by (Responsible Party):
St. Jude Medical

Brief Summary:
Expand the indication of the Portico TF Delivery System and obtain approval of the Alternative Access Delivery System

Condition or disease Intervention/treatment Phase
Aortic Valve Stenosis Device: Subclavian or Transaortic TAVR Implant Phase 2 Phase 3

Detailed Description:
Expand the indication of the Portico TF Delivery System and obtain approval of the Alternative Access Delivery System to place a Portico transcatheter aortic valve through an alternative access site, specifically subclavian/axillary or transaortic (TAo) in subjects with symptomatic severe native aortic stenosis who are considered high surgical risk

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Portico TF and ALT Delivery System
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Assessment of the St Jude Medical Portico Resheathable Aortic Valve System-Alternative Access
Actual Study Start Date : March 14, 2017
Estimated Primary Completion Date : November 2018
Estimated Study Completion Date : February 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Subclavian/axillary
Subclavian/axillary access route
Device: Subclavian or Transaortic TAVR Implant
Transcatheter Aortic Valve Implantation

Experimental: Transaortic
Transaortic access route
Device: Subclavian or Transaortic TAVR Implant
Transcatheter Aortic Valve Implantation




Primary Outcome Measures :
  1. Incidence of major vascular complications [ Time Frame: 30 Days ]
    Major vascular complications


Secondary Outcome Measures :
  1. All cause mortality event rates [ Time Frame: 30 Days ]
    All cause mortality

  2. Cardiovascular mortality event rates [ Time Frame: 30 Days ]
    Cardiovascular mortality

  3. Stroke event rates [ Time Frame: 30 Days ]
    Disabling and non-disabling stroke

  4. Life threatening bleeding event rates [ Time Frame: 30 Days ]
    Life threatening bleeding requiring transfusion

  5. Acute kidney injury event rates [ Time Frame: 30 Days ]
    Acute kidney injury requiring dialysis

  6. Mortality event rates [ Time Frame: 1 year ]
    All cause mortality

  7. Cardiovascular mortality event rates [ Time Frame: 1 year ]
    Cardiovascular mortality

  8. Stroke event rates [ Time Frame: 1 year ]
    Disabling stroke

  9. Aortic Regurgitation event rates [ Time Frame: 1 year ]
    Moderate and severe aortic regurgitation

  10. NYHA improvement from baseline [ Time Frame: 30 Days ]
    NYHA classification

  11. Six minute walk improvement from baseline [ Time Frame: 30 Days ]
    Six minute walk

  12. EOA improvement from baseline [ Time Frame: 30 Days ]
    Effective orifice area

  13. Acute Device Success [ Time Frame: 7 days ]
    Acute Device Success as defined by VARC-2



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Subject has provided written informed consent prior to uploading CT scan to core lab.
  2. Subject is 65 years of age or older at the time of index procedure, and/or has comorbidities that, in the opinion of the Principal Investigator or the Subject Selection Committee, preclude surgical valve replacement.
  3. Subject's aortic annulus diameter meets the range indicated in the Instructions for Use as measured by multislice CT conducted within 180 days prior to the index procedure.
  4. Subject has senile degenerative aortic stenosis seen by echocardiography within 90 days of index procedure as measured by:

    • mean gradient >40 mmHg or jet velocity greater than 4.0 m/s or Doppler Velocity Index <0.25, and
    • an initial aortic valve area (AVA) of ≤ 1.0 cm2 (indexed EOA ≤ 0.6 cm2/m2).
  5. Subject has symptomatic aortic stenosis as demonstrated by NYHA Functional Classification of Class II, or greater or other symptoms of aortic stenosis (e.g. syncope).
  6. Subject is deemed high operable risk and preferred TAVI delivery route is alternate access (subclavian/axillary or direct aortic) per the medical opinion of the center's heart team.

    • High risk is defined as an STS mortality > 8% or documented heart team agreement ≥ high risk for SAVR due to frailty or co-morbidities

Exclusion Criteria:

  1. Subject is unwilling or unable to comply with all study-required follow-up evaluations.
  2. Subject has a documented history of a cerebral vascular accident (CVA) or transient ischemic attack (TIA) within 6 months (less than or equal to 180 days) prior to the index procedure.
  3. Subject has carotid artery disease requiring intervention.
  4. Subject has evidence of an acute ST-segment elevation myocardial infarction (MI) within 30 days prior to patient index procedure (defined as: ST Segment Elevation as evidenced on 12 Lead ECG).
  5. Subject has a native aortic valve that is congenitally unicuspid, bicuspid, quadricuspid or non-calcified as seen by echocardiography.
  6. Subject has severe mitral valvular regurgitation.
  7. Subject has severe mitral stenosis.
  8. Subject has a pre-existing prosthetic cardiac device, valve, or prosthetic ring in any position.
  9. Subject refuses any blood product transfusion.
  10. Subject has resting left ventricular ejection fraction (LVEF) less than 20%.
  11. Subject has documented, untreated symptomatic coronary artery disease (CAD) requiring revascularization.
  12. Subject has had a percutaneous interventional or other invasive cardiovascular or peripheral vascular procedure less than or equal to 14 days prior to index procedure.
  13. Subject has severe basal septal hypertrophy that would interfere with transcatheter aortic valve placement.
  14. Subject has a history of, or is currently diagnosed with, endocarditis.
  15. There is imaging evidence of intracardiac mass, thrombus, or vegetation.
  16. Subject is considered hemodynamically unstable (requiring inotropic support or mechanical heart assistance).
  17. Subject is in acute pulmonary edema or requiring intravenous diuretic therapy to stabilize heart failure.
  18. Subject with severe pulmonary disease as determined by STS score.
  19. Subject is on chronic oral steroid therapy.
  20. Subject has a documented hypersensitivity or contraindication to anticoagulant or antiplatelet medication.
  21. Subject has renal insufficiency as evidenced by a serum creatinine greater than 3.0 mg/dL (265.5 µmol/L) or end-stage renal disease requiring chronic dialysis.
  22. Subject has morbid obesity defined as a BMI greater than or equal to 40.
  23. Subject has ongoing infection or sepsis.
  24. Subject has uncontrolled blood dyscrasias as defined: leukopenia (WBC<3000 mm3), acute anemia (Hb<9 mg/dL), thrombocytopenia (platelet count <50,000 cells/mm3,).
  25. Anatomy falling outside the recommended values in the IFU, unless specifically approved by the Subject Selection Committee.
  26. Subject has an active peptic ulcer or has had gastrointestinal (GI) bleeding within 90 days prior to the index procedure.
  27. Subject is currently participating in another investigational drug or device study, unless approved by the Sponsor.
  28. Subject has/had emergency surgery for any reason within 30 days of the index procedure.
  29. Subject has a life expectancy less than 1 year.
  30. Subject has other medical, social or psychological conditions that, in the opinion of the Principal Investigator or the Subject Selection Committee, preclude the subject from study participation.
  31. Subject is diagnosed with a state of dementia which would fundamentally complicate rehabilitation from the procedure or compliance with follow-up visits.
  32. Subject has a documented allergy to contrast media that cannot adequately be treated, nitinol alloys, porcine tissue, or bovine tissue.

Transaortic Subject Cohort Specific Exclusion Criteria

  1. Subject has a chest condition (anatomical or otherwise) that prevents TAo access.
  2. Subject has pre-existing patent RIMA graft that would preclude access.
  3. Subject has a porcelain aorta, defined as an extensive circumferential calcification of the ascending aorta that would complicate TAo access.

Subclavian/Axillary Subject Cohort Specific Exclusion Criteria

  1. Subject's access vessel (subclavian/axillary) diameter will not allow for introduction of the 18/19 Fr delivery system.
  2. Subject's subclavian/axillary arteries have severe calcification and/or tortuosity.
  3. Subject has a history of LIMA/RIMA graft that would preclude access

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): NCT03056573


Contacts
Contact: Jennifer Johnson 6517566803 jjohnson101@sjm.com

Locations
Denmark
Rigshospitalet Copenhagen Recruiting
Copenhagen, Denmark
Principal Investigator: Lars Soendergaard, MD         
Germany
Deutsches Herzzentrum Berlin Recruiting
Berlin, Germany
Principal Investigator: Joerg Kempferg, MD         
Herzzentrum Leipzig GmbH Recruiting
Leipzig, Germany
Principal Investigator: Axel Linke, MD         
Italy
Policlinico San Donato Recruiting
San Donato Milanese, Italy
Principal Investigator: Francesco Bedogni, MD         
Netherlands
Medical Center Leeuwarden Recruiting
Leeuwarden, Netherlands
Contact: Han Blomer         
Principal Investigator: Hafid Amrane, MD         
UMC St Radboud Recruiting
Nijmegen, Netherlands
Principal Investigator: Marleen van Wely, MD         
Switzerland
Basel University Hospital Recruiting
Basel, Switzerland
Principal Investigator: Raban Jeger, MD         
Sponsors and Collaborators
St. Jude Medical

Responsible Party: St. Jude Medical
ClinicalTrials.gov Identifier: NCT03056573     History of Changes
Other Study ID Numbers: SJM-CIP-10144
First Posted: February 17, 2017    Key Record Dates
Last Update Posted: April 20, 2018
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by St. Jude Medical:
TAVI
Valvular heart disease
Transcatheter aortic valve implantation

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