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Trial record 1 of 26 for:    SHIELD II
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Supporting Patients Undergoing HIgh-Risk PCI Using a High-Flow PErcutaneous Left Ventricular Support Device (SHIELD II) (SHIELD II)

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: NCT02468778
Recruitment Status : Suspended
First Posted : June 11, 2015
Last Update Posted : December 15, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The HeartMate PHP System is a temporary (<6 hours) ventricular assist device indicated for use during high risk percutaneous coronary interventions (PCI) performed in elective or urgent, hemodynamically stable patients with severe coronary artery disease and depressed left ventricular ejection fraction.

Condition or disease Intervention/treatment
Coronary Artery Disease Device: HeartMate PHP Device: Any Abiomed Impella® device approved for use in high-risk PCI

Detailed Description:

Prospective, randomized, multi-center, open-label trial of the HeartMate PHP at up to 100 sites in the US. Control device will be any Abiomed Impella device approved for use in high-risk PCI.

Nonrandomized roll-in phase: Each site must first enroll and treat up to 6 patients (up to 3 PHP and 3 Impella per site)

Randomized phase: Up to 425 patients undergoing PCI per the Inclusion/Exclusion criteria.


Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 425 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Supporting Patients Undergoing HIgh-Risk PCI Using a High-Flow PErcutaneous Left Ventricular Support Device (SHIELD II)
Actual Study Start Date : August 2015
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: 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 in elective or urgent, hemodynamically stable patients with severe coronary artery disease and depressed left ventricular ejection fraction.
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 in elective or urgent, hemodynamically stable patients with severe coronary artery disease and depressed left ventricular ejection fraction.
Active Comparator: Any Abiomed Impella® device approved for use in high-risk PCI
Any Abiomed Impella® Device approved for use in high-risk PCI
Device: Any Abiomed Impella® device approved for use in high-risk PCI
Any Abiomed Impella® device approved for use in high-risk PCI


Outcome Measures

Primary Outcome Measures :
  1. Cardiac Death [ Time Frame: 90 Days ]
    Death occurring within 90 days after device use due to a cardiovascular cause

  2. Myocardial Infarction [ Time Frame: 90 Days ]
    Periprocedural or spontaneous myocardial infarction within 90 days after device use as measured by biomarkers and/or ECG and/or symptomatology

  3. Stroke [ Time Frame: 90 Days ]
    Cerebral infarction occurring within 90 days after device use as measured by clinical assessment and/or diagnostic imaging

  4. Repeat revascularization (PCI or CABG) [ Time Frame: 90 Days ]
    Additional PCI or CABG surgery occurring within 90 days after device use

  5. Bleeding [ Time Frame: 90 Days ]
    Major bleeding (BARC category 3 or 5) occurring within 90 days after device use

  6. Aortic Insufficiency (AI) [ Time Frame: 90 Days ]
    Change in AI from baseline to 90 days

  7. Severe hypotension [ Time Frame: Intraprocedural ]
    Systolic blood pressure <90 mmHg while on device support requiring inotropic/pressor medications to restore hemodynamics


Secondary Outcome Measures :
  1. All death [ Time Frame: 90 Days ]
    Death due to any cause occurring within 90 days of device use

  2. Hemodynamic measure: Maximal change in cardiac power output (CPO) from baseline [ Time Frame: 90 Days ]
    CPO as calculated from mean arterial pressure and cardiac output

  3. Hemodynamic measure: Maximal change in central venous pressure (CVP) from baseline [ Time Frame: 90 Days ]
    CVP as measured by direct right heart catheterization

  4. Hemodynamic measure: Maximal change in mean arterial pressure (MAP) [ Time Frame: 90 Days ]
    MAP as measured by direct right heart catheterization

  5. Hemodynamic measure: Maximal change in pulmonary artery pressure (PAP) from baseline [ Time Frame: 90 Days ]
    PAP as measured by direct right heart catheterization

  6. Hemodynamic measure: Maximal change in pulmonary capillary wedge pressure (PCWP) from baseline [ Time Frame: 90 Days ]
    PCWP as measured by direct right heart catheterization

  7. Hemodynamic measure: Maximal change in cardiac output (CO) from baseline [ Time Frame: 90 Days ]
    CO as measured by direct right heart catheterization

  8. Hemodynamic measure: Maximal change in cardiac index (CI) from baseline [ Time Frame: 90 Days ]
    CI as measured by direct right heart catheterization

  9. Device-related access site complication requiring intervention or device-related limb ischemia [ Time Frame: 90 Days ]
    Major and minor vascular complications, including those due to percutaneous closure device failure occurring within 90 days of device use

  10. Surgical intervention due to device complication or malfunction [ Time Frame: 90 Days ]
    Any device complication or malfunction requiring surgical intervention for resolution within 90 days of device use

  11. Duration of hospital stay [ Time Frame: Hospital Discharge ]
    Number of hospital days associated within the initial study hospitalization

  12. Intensive care unit (ICU) days [ Time Frame: Hospital Discharge ]
    Number of ICU days associated within the initial study hospitalization

  13. Individual components of the composite primary endpoint [ Time Frame: 90 Days ]
    Measurement of cardiac death, myocardial infarction, stroke, repeat revascularization (PCI or CABG), bleeding (BARC 3 or 5), aortic regurgitation +1 degree over baseline and severe hypotension, defined as: systolic blood pressure <90 mmHg while on device support requiring inotropic/pressor medications to restore hemodynamics

  14. Change in aortic insufficiency [ Time Frame: At the time of post-procedure (within 48 hours post device removal) and again at the time of hospital discharge (typically within one week after the procedure) ]
    Change in aortic insufficiency from baseline to post-procedure, and hospital discharge

  15. Change in LDH [ Time Frame: At the time of hospital discharge (typically within one week after the procedure) ]
    Change in LDH from baseline to hospital discharge

  16. Change in PHgb [ Time Frame: At the time of hospital discharge (typically within one week after the procedure) ]
    Change in PHgb from baseline to hospital discharge

  17. Technical success (at exit from cath lab) [ Time Frame: At the time of procedure completion (typically within 6 hours after the study device is inserted) ]

    Alive, with:

    1. Successful access, function, delivery and retrieval of the device and delivery system, and
    2. Deployment and correct positioning of the single intended device, and
    3. No need for additional unplanned or emergency surgery or re-intervention related to the device or access procedure

  18. Device success (hospital discharge) [ Time Frame: At the time of hospital discharge (typically within one week after the procedure) ]

    Alive and stroke free with:

    1. No peri-procedural MI or post procedural spontaneous MI
    2. No additional interventional or surgical procedures related to device access (e.g., treatment of limb ischemia, etc.) or recurrent/ongoing myocardial ischemia (i.e., additional PCI or CABG after exit from cath lab)
    3. Intended performance of the device:

      1. No severe hypotension, defined as : systolic blood pressure <90 mmHg while on device support requiring inotropic/pressor medications to restore hemodynamics
      2. Complete revascularization of all ischemia producing lesions achieved as planned (i.e., complete planned revascularization achieved)
      3. No structural cardiac device complications

  19. Individual Patient Success [ Time Frame: 90 days ]

    Device Success and all of the following:

    1. No re-hospitalizations, re-interventions, or surgery for the underlying condition (e.g. ischemic CAD)
    2. Improvement vs. baseline in symptoms (e.g., improvement in Canadian Cardiovascular Society Class >1); and
    3. Significant improvement vs. baseline in health status (e.g. patient reported health status measure validated for patient with angina or CAD). Assessments will include the Seattle Angina Questionnaire (SAQ) and EQ-5D.

  20. Myocardial infarction [ Time Frame: 90 days ]
    criteria of CKMB >5X ULN and >10X ULN


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • At least 18 years of age
  • Patient is undergoing elective or urgent high risk PCI procedure and is hemodynamically stable
  • Patient 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
  • 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:

    o an ejection fraction of ≤35% 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
  • Written, signed, and dated informed consent

Exclusion Criteria:

  • • Emergency PCI
  • Any prior coronary revascularization within the last six months
  • Myocardial infarction at baseline defined as:

ST Elevation MI (STEMI):

Subject has clinical symptoms and/or ECG changes (new pathological Q waves in 2 contiguous leads) consistent with acute ST elevation MI (STEMI) within 72 hours prior to the index procedure.

Non-STEMI:

Hemodynamically unstable with biomarker elevation (CK-MB or Troponin >1x URL) and/or no evidence of at least 1 consecutive troponin or CK-MB value trending downward from previous value.

URL = upper range limit, defined as 99th percentile of normal reference range

  • Cardiac arrest within 24 hours of procedure requiring CPR or defibrillation
  • Hemodynamic support with the HeartMate PHP post-PCI is anticipated
  • Cardiogenic shock (systolic blood pressure (SBP) <90 mmHg for >1 hour with either cool clammy skin OR oliguria OR altered sensorium AND cardiac index <2.2 L/min/m2)
  • Mural thrombus in the left ventricle
  • History of aortic valve replacement
  • Documented presence of aortic stenosis (orifice area of 1.5cm2 or less)
  • Moderate to severe aortic insufficiency by echocardiographic assessment
  • Severe peripheral vascular disease
  • Known abnormalities of the aorta that would preclude surgery, including aneurysms and significant tortuosity or calcifications
  • Patient is on hemodialysis
  • Liver dysfunction with elevation of liver enzymes and bilirubin levels to ≥ 3x upper limit of normal (ULN) or INR (International Normalized Ratio) ≥2 or lactate dehydrogenase (LDH) > 2.5x ULN.
  • Uncorrectable abnormal coagulation parameters (platelet count ≤75000/mm3 or INR ≥2.0 or fibrinogen ≤1.5 g/l)
  • Active systemic infection requiring treatment with antibiotics
  • Stroke or transient ischemic attack (TIA) within 6 month of procedure
  • Any allergy or intolerance to ionic and nonionic contrast media, anticoagulants, or antiplatelet therapy drugs that cannot be adequately premedicated
  • Patient is pregnant
  • Participation in another clinical study of an investigational drug or device that has not met its primary endpoint
Contacts and Locations

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): NCT02468778


  Show 62 Study Locations
Sponsors and Collaborators
St. Jude Medical
Thoratec, LLC
Investigators
Study Director: Mariah Tackett Abbott
More Information

Responsible Party: St. Jude Medical
ClinicalTrials.gov Identifier: NCT02468778     History of Changes
Other Study ID Numbers: HeartMate PHP™ SHIELD II
First Posted: June 11, 2015    Key Record Dates
Last Update Posted: December 15, 2017
Last Verified: December 2017

Keywords provided by St. Jude Medical:
HeartMate PHP
High Risk PCI
Left Ventricular Dysfunction
Thoratec Corporation

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases