SHIELD II Clinical Investigation (SHIELD II)

June 20, 2022 updated by: Abbott Medical Devices

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
54

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85258
        • Scottsdale Shea Medical Center
      • Tucson, Arizona, United States, 85724
        • University of Arizona
    • California
      • Los Angeles, California, United States, 90048
        • Cedars-Sinai Medical Center
      • Los Angeles, California, United States, 90027
        • Kaiser Permanente Los Angeles Medical Center
      • Los Angeles, California, United States, 90033
        • USC University Hospital
      • Orange, California, United States, 92868
        • St.Joseph Hospital
    • Florida
      • Miami, Florida, United States, 33136
        • University of Miami
      • Orlando, Florida, United States, 32806
        • Orlando Regional Medical Center
    • Georgia
      • Atlanta, Georgia, United States, 30309
        • Piedmont Heart Institute
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern University
      • Chicago, Illinois, United States, 60637
        • University of Chicago
    • Iowa
      • West Des Moines, Iowa, United States, 50266
        • Iowa Heart Center
    • Kansas
      • Wichita, Kansas, United States, 67226
        • Cardiovascular Research Institute of Kansas
    • Louisiana
      • New Orleans, Louisiana, United States, 70121
        • Ochsner Medical Center
      • New Orleans, Louisiana, United States, 70112
        • Louisiana State University Health Sciences Center
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital
      • Boston, Massachusetts, United States, 02111
        • Tufts Medical Center
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconness Medical Center
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Henry Ford Hospital
      • Grand Rapids, Michigan, United States, 49503
        • Spectrum Health Butterworth Hospital
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • University of Minnesota Medical Center Fairview
    • Mississippi
      • Tupelo, Mississippi, United States, 38801
        • North Mississippi Medical Center
    • Missouri
      • Kansas City, Missouri, United States, 64111
        • St. Luke's Hospital
      • Saint Louis, Missouri, United States, 63110
        • Barnes-Jewish Hospital
      • Springfield, Missouri, United States, 65804
        • Mercy Medical Research Institute, Springfield
    • Nebraska
      • Omaha, Nebraska, United States, 68198
        • University of Nebraska Medical Center
    • New Jersey
      • Voorhees, New Jersey, United States, 08043
        • Lourdes Cardiology Services
    • New Mexico
      • Albuquerque, New Mexico, United States, 87102
        • New Mexico Heart Institute
    • New York
      • Bronx, New York, United States, 10467
        • Montefiore Medical Center - Moses Division
      • Brooklyn, New York, United States, 11219
        • Maimonides
      • New York, New York, United States, 10016
        • New York University
      • New York, New York, United States, 10029
        • Mount Sinai Hospital
      • New York, New York, United States, 10032
        • Columbia University Medical Center/New York Presbyterian Hospital
      • Rochester, New York, United States, 14642
        • University of Rochester Medical Center
      • Roslyn, New York, United States, 11576
        • St. Francis Hospital
      • Stony Brook, New York, United States, 11794
        • Stony Brook University Medical Center
    • North Carolina
      • Durham, North Carolina, United States, 27705
        • Duke University Medical Center
      • Winston-Salem, North Carolina, United States, 27157
        • Wake Forest University Medical Center Clinical Sciences
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • The Christ Hospital
      • Cincinnati, Ohio, United States, 45267
        • University of Cincinnati
      • Cleveland, Ohio, United States, 44106
        • University Hospitals Cleveland
      • Columbus, Ohio, United States, 43210
        • Ohio State University
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73112
        • INTEGRIS Baptist Medical Center
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Hospital of the University of Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15212
        • Allegheny Singer Research Institute
    • Rhode Island
      • Providence, Rhode Island, United States, 02906
        • The Miriam Hospital
    • Tennessee
      • Germantown, Tennessee, United States, 38138
        • The Stern Cardiovascular Foundation
      • Nashville, Tennessee, United States, 37203
        • Centennial Medical Center
    • Texas
      • Austin, Texas, United States, 78705
        • Seton Medical Center
      • Houston, Texas, United States, 77030
        • Memorial Hermann Hospital
      • Houston, Texas, United States, 77030
        • Baylor St. Luke's Medical Center
      • Houston, Texas, United States, 77030
        • Methodist Hospital
      • Plano, Texas, United States, 75074
        • The Heart Hospital Baylor Plano
    • Virginia
      • Falls Church, Virginia, United States, 22042
        • Inova Fairfax Hospital
      • Norfolk, Virginia, United States, 23507
        • Sentara Norfolk General Hospital
      • Winchester, Virginia, United States, 22601
        • Winchester Medical Center
    • Washington
      • Seattle, Washington, United States, 98195
        • University of Washington Medical Center
      • Seattle, Washington, United States, 98122
        • Swedish Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 100 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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:

• 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

Exclusion Criteria:

  • 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
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: HeartMate PHP (Roll-in)
Participants who receive a HeartMate PHP device without randomisation will be included in this arm
Device: HeartMate PHP
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.
Experimental: HeartMate PHP (Randomised)
Participants who receive a HeartMate PHP device after randomisation will be included in this arm
Device: HeartMate PHP
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.
Active Comparator: Any Abiomed Impella® (Randomised)
Participants who receive any Abiomed Impella® Device approved for use in high-risk PCI after randomisation will be included in this arm
Device: Any Abiomed Impella® device approved for use in high-risk PCI
Any Abiomed Impella® device approved for use in high-risk PCI.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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

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.
90 Days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Abbott Medical Devices

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 17, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 17, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 29, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 8, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 11, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 28, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 20, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SJM-CIP-10148 Ver. J

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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