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Symptomatic Aortic StenosisPorticoALTEUNCT02088021

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

A study testing Portico Transcatheter Aortic Valve in people with Symptomatic Aortic Stenosis, run by Abbott Medical Devices.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 65 years and older
Conditions the study is for
Symptomatic Aortic Stenosis
What is being tested?
Portico Transcatheter Aortic Valve
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
Jan 2014to Dec 2015
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • 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
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  • 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.

Who cannot join

  • 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.
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  • 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.

About this study

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.

Being tested
Portico Transcatheter Aortic Valve

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Portico Transcatheter Aortic ValveDevice

    Placement of the SJM Portico aortic valve with a ALC delivery system

Study groups in NCT02088021
Study groupRoleWhat they receive
Portico Transcatheter Aortic Valve ImplantationExperimentalPlacement of the SJM Portico aortic valve with a ALC delivery system
Receives: Device: Portico Transcatheter Aortic Valve

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Major Vascular Complications related to the Portico ALC Delivery System

    Measured: 30 day post procedure

  2. All cause mortality

    Measured: 30 day post procedure

Secondary outcomes (3)

  1. Event Rates

    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."

    Measured: 30 days post procedure

  2. Functional improvement from baseline

    Functional improvement from baseline as compared to 30 days by:

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

    Measured: 30 days post procedure

  3. Acute device success

    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

    Measured: 12 months post procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Mar 2014 (estimated)
  2. Study startJan 2014
  3. Primary completionFeb 2015 (estimated)
  4. Study completionDec 2015 (estimated)

Why it stopped: Business decision

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02088021
Sponsor's protocol ID
CL07045
Acronym
PorticoALTEU
Status last verified
Feb 2019
First submitted
4 Mar 2014
Last updated
4 Feb 2019
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A study testing Portico Transcatheter Aortic Valve in people with Symptomatic Aortic Stenosis, run by Abbott Medical Devices.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 66 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 4 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Major Vascular Complications related to the Portico ALC Delivery System (time frame: 30 day post procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02088021.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2019.

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