Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Assessment of the St. Jude Medical PorticoTM Re-sheathable Aortic Valve System - Alternative Access (PorticoALTEU)

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: NCT02088021
Recruitment Status : Withdrawn (Business decision)
First Posted : March 14, 2014
Last Update Posted : February 4, 2019
Sponsor:
Information provided by (Responsible Party):
Abbott Medical Devices

Brief Summary:
The purpose of this clinical investigation is to evaluate the use of the Portico ALC Delivery System to place a transcatheter aortic valve through an alternative access site, specifically subclavian/axillary or TAo.

Condition or disease Intervention/treatment Phase
Symptomatic Aortic Stenosis Device: Portico Transcatheter Aortic Valve Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : January 2014
Estimated Primary Completion Date : February 2015
Estimated Study Completion Date : December 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Portico Transcatheter Aortic Valve Implantation
Placement of the SJM Portico aortic valve with a ALC delivery system
Device: Portico Transcatheter Aortic Valve
Placement of the SJM Portico aortic valve with a ALC delivery system




Primary Outcome Measures :
  1. Major Vascular Complications related to the Portico ALC Delivery System [ Time Frame: 30 day post procedure ]
  2. All cause mortality [ Time Frame: 30 day post procedure ]

Secondary Outcome Measures :
  1. Event Rates [ Time Frame: 30 days post procedure ]

    Event rates as described by VARC-2

    "Updated standardized endpoint definitions for transcatheter aortic valve implantation: the Valve Academic Research Consortium-2 consensus document European Heart Journal (2012) 33, 2403-2418."


  2. Functional improvement from baseline [ Time Frame: 30 days post procedure ]

    Functional improvement from baseline as compared to 30 days by:

    • NYHA Functional Classification
    • Six Minute Walk Test
    • Effective Orifice Area (EOA)

  3. Acute device success [ Time Frame: 12 months post procedure ]

    Acute device success defined as:

    • Ability of the Portico ALC Delivery System to successfully deliver, deploy, and resheath (if necessary) a transcatheter aortic valve
    • Absence of procedural mortality
    • Correct positioning of a single prosthetic heart valve into the proper anatomical location
    • Intended performance of the prosthetic heart valve, as defined by:
    • mean aortic valve gradient <20 mmHg or peak velocity <3 m/s, and
    • no moderate or severe prosthetic valve regurgitation



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.


Layout table for eligibility information
Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject has provided written informed consent.
  • 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.
  • Subject's aortic annulus diameter meets the range indicated in the Instructions for Use as measured by multislice CT conducted within 120 days prior to the index procedure.
  • Subject has senile degenerative aortic stenosis with echocardiography within 30 days of index procedure as defined by at least 1 of the following:

    • derived mean gradient greater than 40 mmHg, OR
    • jet velocity greater than 4.0 m/s, OR
    • aortic valve area of less than 0.8 cm2, OR
    • aortic valve area index less than or equal to 0.6 cm2/m2.
  • Subject has symptomatic aortic stenosis as demonstrated by NYHA Functional Classification of II, III, or IV.
  • Subject is deemed high operable risk and delivery route is suitable for TAVI per the medical opinion of the Subject Selection Committee.
  • Subject's predicted operative mortality or serious, irreversible morbidity risk is less than 50% at 30 days post index procedure.

Exclusion Criteria:

  • Subject is unwilling or unable to comply with all study-required follow-up evaluations.
  • 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.
  • Subject has carotid artery disease requiring intervention.
  • Evidence of an acute myocardial infarction (MI) within 30 days prior to patient providing consent (defined as: ST Segment Elevation as evidenced on 12 Lead ECG).
  • Subject has a native aortic valve that is congenitally unicuspid, bicuspid, quadricuspid or non-calcified as seen by echocardiography.
  • Subject has mitral valvular regurgitation greater than grade III.
  • Subject has moderate or severe mitral stenosis.
  • Subject has a pre-existing prosthetic cardiac device, valve, or prosthetic ring in any position.
  • Subject refuses any blood product transfusion.
  • Subject refuses surgical valve replacement.
  • Subject has left ventricular ejection fraction (LVEF) less than 20%.
  • Subject has documented, untreated symptomatic coronary artery disease (CAD) requiring revascularization.
  • Subject has had a percutaneous interventional or other invasive cardiovascular or peripheral vascular procedure less than or equal to 14 days of index procedure.
  • Subject has severe basal septal hypertrophy that would interfere with transcatheter aortic valve placement.
  • Subject has a history of, or is currently diagnosed with endocarditis.
  • There is imaging evidence of intracardiac mass, thrombus, or vegetation.
  • Subject is considered hemodynamically unstable (requiring inotropic support or mechanical heart assistance).
  • Subject is in acute pulmonary edema or requiring intravenous diuretic therapy to stabilize heart failure.
  • Subject with significant pulmonary disease as determined and documented by the Investigator.
  • Subject has significant chronic steroid use as determined and documented by the Investigator.
  • Subject has a documented hypersensitivity or contraindication to anticoagulant or antiplatelet medication.
  • 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.
  • Subject has morbid obesity defined as a BMI greater than or equal to 40.
  • Subject has ongoing infection or sepsis.
  • Subject has blood dyscrasias (eg, leukopenia, acute anemia, thrombocytopenia, history of bleeding diathesis, or coagulopathy).
  • Subject has a current autoimmune disease that, in the opinion of the Principal Investigator or the Subject Selection Committee, precludes the subject from study participation.
  • Significant ascending aortic disease documented by diameter greater than 40mm.
  • Subject has an active peptic ulcer or has had gastrointestinal (GI) bleeding within 90 days prior to the index procedure.
  • Subject is currently participating in another investigational drug or device study.
  • Subject requires emergency surgery for any reason.
  • Subject has a life expectancy less than 12 months.
  • 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.
  • Subject is diagnosed with dementia or admitted to a chronic care facility which would fundamentally complicate rehabilitation from the procedure or compliance with follow-up visits.
  • Subject is unwilling or unable to comply with all study-required follow-up evaluations.
  • 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.
  • Subject has carotid artery disease requiring intervention.
  • Evidence of an acute myocardial infarction (MI) within 30 days prior to patient providing consent (defined as: ST Segment Elevation as evidenced on 12 Lead ECG).
  • Subject has a native aortic valve that is congenitally unicuspid, bicuspid, quadricuspid or non-calcified as seen by echocardiography.
  • Subject has mitral valvular regurgitation greater than grade III.
  • Subject has moderate or severe mitral stenosis.
  • Subject has a pre-existing prosthetic cardiac device, valve, or prosthetic ring in any position.
  • Subject refuses any blood product transfusion.
  • Subject refuses surgical valve replacement.
  • Subject has left ventricular ejection fraction (LVEF) less than 20%.
  • Subject has documented, untreated symptomatic coronary artery disease (CAD) requiring revascularization.
  • Cardiovascular or peripheral vascular procedure less than or equal to 14 days of index procedure.
  • Subject has severe basal septal hypertrophy that would interfere with transcatheter aortic valve placement.
  • Subject has a history of, or is currently diagnosed with endocarditis.
  • There is imaging evidence of intracardiac mass, thrombus, or vegetation.
  • Subject is considered hemodynamically unstable (requiring inotropic support or mechanical heart assistance).
  • Subject is in acute pulmonary edema or requiring intravenous diuretic therapy to stabilize heart failure.
  • Subject with significant pulmonary disease as determined and documented by the Investigator.
  • Subject has significant chronic steroid use as determined and documented by the Investigator.
  • Subject has a documented hypersensitivity or contraindication to anticoagulant or antiplatelet medication.
  • 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.
  • Subject has morbid obesity defined as a BMI greater than or equal to 40.
  • Subject has ongoing infection or sepsis.
  • Subject has blood dyscrasias (eg, leukopenia, acute anemia, thrombocytopenia, history of bleeding diathesis, or coagulopathy).
  • Significant ascending aortic disease documented by diameter greater than 40mm.
  • Subject has an active peptic ulcer or has had gastrointestinal (GI) bleeding within 90 days prior to the index procedure.
  • Subject is currently participating in another investigational drug or device study.
  • Subject requires emergency surgery for any reason.
  • Subject has a life expectancy less than 12 months.
  • 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.
  • Subject is diagnosed with dementia or admitted to a chronic care facility which would fundamentally complicate rehabilitation from the procedure or compliance with follow-up visits.
  • Subject has a documented allergy to contrast media, nitinol alloys, porcine tissue, or bovine tissue.

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): NCT02088021


Sponsors and Collaborators
Abbott Medical Devices
Investigators
Layout table for investigator information
Principal Investigator: Axel Linke, Prof Dr. med Heart Center Leipzig - University Hospital
Layout table for additonal information
Responsible Party: Abbott Medical Devices
ClinicalTrials.gov Identifier: NCT02088021    
Other Study ID Numbers: CL07045
First Posted: March 14, 2014    Key Record Dates
Last Update Posted: February 4, 2019
Last Verified: February 2019
Additional relevant MeSH terms:
Layout table for MeSH terms
Aortic Valve Stenosis
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction