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Coronary Artery DiseaseSHIELD IINCT02468778

SHIELD II Clinical Investigation

A study testing HeartMate PHP and Any Abiomed Impella® device approved for use in high-risk PCI in people with Coronary Artery Disease, run by Abbott Medical Devices at 58 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The HeartMate PHP System is a temporary (<6 hours) ventricular assist device indicated for use during high-risk percutaneous coronary interventions (PCI) performed electively or urgently in hemodynamically stable patients with severe coronary artery disease, when a heart team, including a cardiac surgeon, has… Read more about this study

Who is it for?
Ages 18 to 100 years
Conditions the study is for
Coronary Artery Disease
What is being tested?
HeartMate PHP and Any Abiomed Impella® device approved for use in high-risk PCI
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
54 participants
Where
58 sitesUnited States
Study dates
Aug 2015to 17 May 2021
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 18 to 100 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • At least 18 years of age
  • Subject is undergoing elective or urgent high-risk PCI procedure and is hemodynamically stable
  • Subject is indicated for a revascularization of at least one de novo or restenotic lesion in a native coronary vessel or bypass graft
  • A heart team, including a cardiac surgeon, has determined high risk PCI is an acceptable therapeutic option
  • Subject must provide written informed consent prior to any clinical investigation related procedure
  • Imaging Inclusion Criteria:
Show all 10Show fewer
  • The presence of complex coronary artery disease (CAD) makes hemodynamic instability resulting from repeat episodes of reversible myocardial ischemia during PCI likely. Complex CAD is defined as an ejection fraction of <50% by echocardiographic assessment AND at least one of the following:
  • intervention of the last patent coronary conduit, OR
  • intervention of an unprotected left main artery, OR
  • intervention on patient presenting with triple vessel disease defined as at least one significant stenosis (at least 50% diameter stenosis on visual assessment) in all three major epicardial territories

Who cannot join

  • Emergency PCI
  • Any prior coronary revascularization within the last 6 months
  • Any MI with elevated cardiac biomarker (creatinine kinase-MB (CK-MB) or troponin >1X upper limit of normal (ULN)) and no evidence of at least 1 consecutive CK-MB or troponin value trending downward from previous value (at least 4 hours apart) OR ST Elevation MI (STEMI) within 72 hours prior to the index procedure regardless of the level of cardiac biomarker
  • Cardiac arrest within 24 hours of procedure requiring cardiopulmonary resuscitation (CPR) or defibrillation
  • Any use of a mechanical circulatory support device within 14 days prior to the index procedure (Note: Subjects must be hemodynamically stable without any hemodynamic support to be eligible for this clinical investigation.)
  • Hemodynamic support with a mechanical circulatory support device (e.g.,the HeartMate PHP, Impella, intra-aortic balloon pump (IABP), or extracorporeal membrane oxygenation (ECMO)), post-PCI is anticipated
Show all 28Show fewer
  • Any condition that requires discontinuation of antiplatelet and/or anticoagulant therapy within 90 days following the index procedure (e.g., planned noncardiac surgery)
  • Any use of vasopressors or inotropes within 24 hours prior to the index procedure
  • Staged PCI is planned within 90 days following device removal
  • Cardiogenic shock (SBP <90 mmHg for >1 hour with either cool clammy skin OR oliguria OR altered sensorium AND cardiac index <2.2 L/min/m^2)
  • History of aortic valve replacement or repair
  • Severe peripheral vascular disease that will preclude the use of a 14F access sheath, which is required for the insertion of the HeartMate PHP catheter (If the investigator is unsure of the presence or severity of the peripheral vascular diseases for study device access, an appropriate imaging assessment (e.g., duplex ultrasound, angiogram or computerized tomography) should be performed to verify the access before randomization.)
  • Known abnormalities of the aorta that would preclude surgery, including aneurysms and significant tortuosity or calcifications
  • Subject is on hemodialysis
  • Liver dysfunction with elevation of liver enzymes and bilirubin levels to ≥ 3X ULN or Internationalized Normalized Ratio (INR) ≥1.6 or lactate dehydrogenase (LDH) > 2.5X ULN
  • Abnormal coagulation parameters (platelet count ≤75000/mm^3 or INR ≥1.6 or fibrinogen ≤1.5 g/l)
  • Active systemic infection requiring treatment with antibiotics
  • Subject had active COVID-19 symptoms and/or a positive test result within the prior 2 months
  • Stroke or transient ischemic attack (TIA) within 6 months of procedure
  • Any allergy or intolerance to ionic and nonionic contrast media, anticoagulants (including heparin), or antiplatelet therapy drugs that cannot be adequately premedicated
  • Subject is pregnant (For a female subject of childbearing potential, a pregnancy test must be performed within 14 days (≤14 days) prior to the index procedure per site standard test)
  • Participation in another clinical study of an investigational drug or device that has not met its primary endpoint
  • Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with followup requirements, or impact the scientific soundness of the clinical investigation results
  • Life expectancy <1 year
  • Imaging Exclusion Criteria:
  • Mural thrombus in the left ventricle
  • Documented presence of aortic stenosis (orifice area of 1.5 cm^2 or less)
  • Moderate to severe aortic insufficiency by echocardiographic assessment

Trial locations and contacts

58 sites in 1 country.

58 sites in 1 country

United States58 sites

  • New Mexico Heart Institute

    Albuquerque, New Mexico, 87102

  • Piedmont Heart Institute

    Atlanta, Georgia, 30309

  • Seton Medical Center

    Austin, Texas, 78705

  • Tufts Medical Center

    Boston, Massachusetts, 02111

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Beth Israel Deaconness Medical Center

    Boston, Massachusetts, 02215

  • Maimonides

    Brooklyn, New York, 11219

  • Northwestern University

    Chicago, Illinois, 60611

  • University of Chicago

    Chicago, Illinois, 60637

  • The Christ Hospital

    Cincinnati, Ohio, 45219

  • University of Cincinnati

    Cincinnati, Ohio, 45267

  • University Hospitals Cleveland

    Cleveland, Ohio, 44106

  • Ohio State University

    Columbus, Ohio, 43210

  • Henry Ford Hospital

    Detroit, Michigan, 48202

  • Duke University Medical Center

    Durham, North Carolina, 27705

  • Inova Fairfax Hospital

    Falls Church, Virginia, 22042

  • The Stern Cardiovascular Foundation

    Germantown, Tennessee, 38138

  • Spectrum Health Butterworth Hospital

    Grand Rapids, Michigan, 49503

  • Baylor St. Luke's Medical Center

    Houston, Texas, 77030

  • Memorial Hermann Hospital

    Houston, Texas, 77030

  • Methodist Hospital

    Houston, Texas, 77030

  • St. Luke's Hospital

    Kansas City, Missouri, 64111

  • Kaiser Permanente Los Angeles Medical Center

    Los Angeles, California, 90027

  • USC University Hospital

    Los Angeles, California, 90033

  • Cedars-Sinai Medical Center

    Los Angeles, California, 90048

  • University of Miami

    Miami, Florida, 33136

  • University of Minnesota Medical Center Fairview

    Minneapolis, Minnesota, 55455

  • Centennial Medical Center

    Nashville, Tennessee, 37203

  • Louisiana State University Health Sciences Center

    New Orleans, Louisiana, 70112

  • Ochsner Medical Center

    New Orleans, Louisiana, 70121

  • New York University

    New York, New York, 10016

  • Mount Sinai Hospital

    New York, New York, 10029

  • Columbia University Medical Center/New York Presbyterian Hospital

    New York, New York, 10032

  • Sentara Norfolk General Hospital

    Norfolk, Virginia, 23507

  • Integris Baptist Medical Center

    Oklahoma City, Oklahoma, 73112

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68198

  • St.Joseph Hospital

    Orange, California, 92868

  • Orlando Regional Medical Center

    Orlando, Florida, 32806

  • Hospital of the University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • Allegheny Singer Research Institute

    Pittsburgh, Pennsylvania, 15212

  • The Heart Hospital Baylor Plano

    Plano, Texas, 75074

  • The Miriam Hospital

    Providence, Rhode Island, 02906

  • University of Rochester Medical Center

    Rochester, New York, 14642

  • St. Francis Hospital

    Roslyn, New York, 11576

  • Scottsdale Shea Medical Center

    Scottsdale, Arizona, 85258

  • Swedish Medical Center

    Seattle, Washington, 98122

  • University of Washington Medical Center

    Seattle, Washington, 98195

  • Mercy Medical Research Institute, Springfield

    Springfield, Missouri, 65804

  • Barnes-Jewish Hospital

    St Louis, Missouri, 63110

  • Stony Brook University Medical Center

    Stony Brook, New York, 11794

  • Montefiore Medical Center - Moses Division

    The Bronx, New York, 10467

  • University of Arizona

    Tucson, Arizona, 85724

  • North Mississippi Medical Center

    Tupelo, Mississippi, 38801

  • Lourdes Cardiology Services

    Voorhees Township, New Jersey, 08043

  • Iowa Heart Center

    West Des Moines, Iowa, 50266

  • Cardiovascular Research Institute of Kansas

    Wichita, Kansas, 67226

  • Winchester Medical Center

    Winchester, Virginia, 22601

  • Wake Forest University Medical Center Clinical Sciences

    Winston-Salem, North Carolina, 27157

Other trials in United States

About this study

Official title: Supporting Patients Undergoing HIgh-Risk PCI Using a High-Flow PErcutaneous Left Ventricular Support Device (SHIELD II)

The HeartMate PHP System is a temporary (<6 hours) ventricular assist device indicated for use during high-risk percutaneous coronary interventions (PCI) performed electively or urgently in hemodynamically stable patients with severe coronary artery disease, when a heart team, including a cardiac surgeon, has determined high-risk PCI is the appropriate therapeutic option. Use of the HeartMate PHP Systems in these patients may prevent hemodynamic instability, which can result from repeat episodes of reversible myocardial ischemia that occur during planned temporary coronary occlusions and may reduce peri-and post-procedural adverse events.

Read the detailed description

Prospective, randomized, multi-center, open-label trial of the HeartMate PHP at up to 120 sites in the United States (U.S.). Control device will be any Abiomed Impella device approved for use in high-risk PCI.

This clinical investigation is divided into two phases, a feasibility phase and a pivotal phase.

  • Feasibility Phase: Includes 75 roll-in and 120 randomized subjects registered under the clinical investigational plan (CIP) versions 2-4 at 48 sites in the U.S. prior to January 30, 2017
  • Pivotal Phase: Includes subjects to be registered under Version F or a later version of the CIP at up to 120 sites in the U.S.

Non-randomized Roll-in Cohort: Up to 480 subjects with the HeartMate PHP.

Randomized Cohort: A minimum of 473 and a maximum of 716 subjects will be randomized in a 2:1 ratio to the HeartMate PHP and Impella.

Being tested
HeartMate PHP, Any Abiomed Impella® device approved for use in high-risk PCI
Keywords
HeartMate PHP, High Risk PCI, Mechanical circulatory support device, MCS, Abbott, SJM-CIP-10148
Medical subject headings
Coronary Artery Disease

What participants receive

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

  • HeartMate PHPDevice

    The HeartMate PHP System is a temporary (<6 hours) ventricular assist device indicated for use during high-risk percutaneous coronary interventions (PCI) performed electively or urgently in hemodynamically stable patients with severe coronary artery disease, when a heart team, including a cardiac surgeon, has determined high-risk PCI is an acceptable therapeutic option. Use of the HeartMate PHP Systems in these patients may prevent hemodynamic instability, which can result from repeat episodes of reversible myocardial ischemia that occur during planned temporary coronary occlusions and may reduce peri-and post-procedural adverse events.

  • Any Abiomed Impella® device approved for use in high-risk PCIDevice

    Any Abiomed Impella® device approved for use in high-risk PCI.

Study groups in NCT02468778
Study groupRoleWhat they receive
HeartMate PHP (Roll-in)ExperimentalParticipants who receive a HeartMate PHP device without randomisation will be included in this arm
Receives: Device: HeartMate PHP
HeartMate PHP (Randomised)ExperimentalParticipants who receive a HeartMate PHP device after randomisation will be included in this arm
Receives: Device: HeartMate PHP
Any Abiomed Impella® (Randomised)Active comparatorParticipants who receive any Abiomed Impella® Device approved for use in high-risk PCI after randomisation will be included in this arm
Receives: Device: Any Abiomed Impella® device approved for use in high-risk PCI

What is being measured

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

  1. Rate of Participants With Composite of Cardiovascular Death, Myocardial Infarction, Stroke, Any Unplanned Repeat Revascularization (PCI/CABG), Bleeding (BARC 3/5) up to 14 Days Post-device Removal, Severe Hypotension, and Change in Aortic Insufficiency

    The primary endpoint, including the following components representing important safety and effectiveness endpoints will be evaluated using the difference in event rates in the ITT population.

    • Cardiovascular Death
    • Myocardial infarction (MI)
    • Stroke
    • Any unplanned repeat revascularization (PCI or CABG)
    • Bleeding (BARC 3 or 5) up to 14 days post-device removal
    • Severe hypotension, defined as: systolic blood pressure (SBP) or augmented diastolic pressure (whichever is greater) <90 mmHg while on device support requiring (1) more than one administration of OR (2) continuous infusion of inotropic/pressor medications to restore hemodynamics
    • Change in aortic insufficiency from baseline to 90 days by echocardiographic assessment.

    Measured: 90 Days

Timeline

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

  1. First posted11 Jun 2015 (estimated)
  2. Study startAug 2015
  3. Primary completion17 May 2021
  4. Study completion17 May 2021

Why it stopped: Abbott has decided to discontinue our percutaneous heart pump (PHP) program and the SHIELD II trial because the product was not meeting the needs of the patients it was intended to serve.

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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
54 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02468778
Sponsor's protocol ID
SJM-CIP-10148 Ver. J
Acronym
SHIELD II
Status last verified
Jun 2022
First submitted
29 May 2015
Last updated
28 Jun 2022
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes

Questions about this trial

What is this clinical trial studying?

A study testing HeartMate PHP and Any Abiomed Impella® device approved for use in high-risk PCI in people with Coronary Artery Disease, run by Abbott Medical Devices at 58 sites in United States.

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 10 inclusion and 28 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: stopped early, as of the sponsor's last update on 28 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 58 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

Yes. Results are posted in the registry (first posted 28 Jun 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Rate of Participants With Composite of Cardiovascular Death, Myocardial Infarction, Stroke, Any Unplanned Repeat Revascularization (PCI/CABG), Bleeding (BARC 3/5) up to 14 Days Post-device Removal, Severe Hypotension, and Change in Aortic Insufficiency (time frame: 90 Days). 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 NCT02468778.

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 28 Jun 2022.

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