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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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02468778
Recruitment Status : Recruiting
First Posted : June 11, 2015
Last Update Posted : October 23, 2020
Sponsor:
Information provided by (Responsible Party):
Abbott Medical Devices

Tracking Information
First Submitted Date  ICMJE May 29, 2015
First Posted Date  ICMJE June 11, 2015
Last Update Posted Date October 23, 2020
Actual Study Start Date  ICMJE August 2015
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 19, 2019)
Rate of participants with cardiovascular death, myocardial infarction, stroke, any unplanned repeat revascularization, bleeding (BARC 3 or 5), severe hypotension, or increase in aortic insufficiency from baseline to 90 days. [ Time Frame: 90 Days ]
The primary endpoint is a composite endpoint. Rate of participants having any of below mentioned events will be recorded.
  • Cardiovascular death
  • Myocardial infarction
  • Stroke
  • Any unplanned repeat revascularization (PCI or CABG)
  • Bleeding (BARC 3 or 5)
  • Severe hypotension
  • Increase in aortic insufficiency from baseline to 90 days
Note: Individual events will be recorded as separate endpoint under secondary outcome measures (as mentioned below).
Original Primary Outcome Measures  ICMJE
 (submitted: June 8, 2015)
  • Cardiac Death [ Time Frame: 90 Days ]
    Death occurring within 90 days after device use due to a cardiovascular cause
  • 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
  • Stroke [ Time Frame: 90 Days ]
    Cerebral infarction occurring within 90 days after device use as measured by clinical assessment and/or diagnostic imaging
  • Repeat revascularization (PCI or CABG) [ Time Frame: 90 Days ]
    Additional PCI or CABG surgery occurring within 90 days after device use
  • Bleeding [ Time Frame: 90 Days ]
    Major bleeding (BARC category 3 or 5) occurring within 90 days after device use
  • Aortic regurgitation [ Time Frame: 90 Days ]
    Aortic regurgitation +1 degree over baseline within 90 days of device use
  • Severe hypotension [ Time Frame: Intraprocedural ]
    Systolic blood pressure <90 mmHg while on device support requiring inotropic/pressor medications to restore hemodynamics
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 19, 2019)
  • Rate of participants with cardiovascular death [ Time Frame: 90 Days ]
    Cardiovascular death includes sudden cardiac death, death due to acute myocardial infarction, death due to heart failure or cardiogenic shock, death due to stroke, death due to other cardiovascular causes, and death due to bleeding.
  • Rate of participants with myocardial Infarction [ Time Frame: 90 Days ]
    • Periprocedural MI (≤ 48 hours post PCI)
    • Spontaneous MI > 48 hours post PCI
  • Rate of participants with stroke [ Time Frame: 90 Days ]
    Cerebral infarction occurring within 90 days after device use as measured by clinical assessment and/or diagnostic imaging.
  • Rate of participants with any unplanned repeat revascularization (PCI or CABG) [ Time Frame: 90 Days ]
    Additional unplanned PCI or CABG surgery occurring within 90 days after device use.
  • Rate of participants with bleeding (BARC category 3 or 5) [ Time Frame: 90 Days ]
    Major bleeding (BARC category 3 or 5) occurring within 90 days after device use.
  • Rate of participants with severe hypotension [ Time Frame: 90 Days ]
    Systolic blood pressure 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.
  • Rate of participants with increase in aortic insufficiency from baseline to 90 days [ Time Frame: 90 Days ]
    Aortic insufficiency will be assessed by echocardiogram (done by the core lab), looking at the increase in aortic regurgitation from baseline.
  • Rate of participants with all-cause death [ Time Frame: 90 Days ]
    Death due to any cause occurring within 90 days of device use
  • Hemodynamic measure: Maximal change in cardiac power output (CPO) from pre-PCI while on device support [ Time Frame: Intraprocedural ]
    CPO as calculated from mean arterial pressure and cardiac output
  • Hemodynamic measure: Maximal change in central venous pressure (CVP) from pre-PCI while on device support [ Time Frame: Intraprocedural ]
    CVP as measured by direct right heart catheterization
  • Hemodynamic measure: Maximal change in mean arterial pressure (MAP) from pre-PCI while on device support [ Time Frame: Intraprocedural ]
    MAP as measured by direct right heart catheterization
  • Hemodynamic measure: Maximal change in pulmonary artery pressure (PAP) from pre-PCI while on device support [ Time Frame: Intraprocedural ]
    PAP as measured by direct right heart catheterization
  • Hemodynamic measure: Maximal change in pulmonary capillary wedge pressure (PCWP) from pre-PCI while on device support [ Time Frame: Intraprocedural ]
    PCWP as measured by direct right heart catheterization
  • Hemodynamic measure: Maximal change in cardiac output (CO) from pre-PCI while on device support [ Time Frame: Intraprocedural ]
    CO as measured by direct right heart catheterization
  • Hemodynamic measure: Maximal change in cardiac index (CI) from pre-PCI while on device support [ Time Frame: Intraprocedural ]
    CI as measured by direct right heart catheterization
  • Rate of participants with 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
  • Rate of participants with 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
  • Duration of hospital stay [ Time Frame: Hospital Discharge ]
    Number of hospital days associated within the initial study hospitalization
  • Intensive care unit (ICU) days [ Time Frame: Hospital Discharge ]
    Number of ICU days associated within the initial study hospitalization
  • Rate of participants with increase in aortic insufficiency from baseline to post-procedure and/or from baseline to discharge [ 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) ]
    Aortic insufficiency will be assessed by echocardiogram (done by the core lab), looking at the increase in aortic regurgitation from baseline.
  • Change in lactate dehydrogenase (LDH) from pre-device insertion to post-device removal [ Time Frame: Intraprocedure ]
  • Change in Plasma-free hemoglobin (PfHgb) from pre-device insertion to post-device removal [ Time Frame: Intraprocedure ]
  • Technical success (at exit from catheterization lab) [ Time Frame: At the time of procedure completion (typically within 6 hours after the study device is inserted) ]
    - Alive, with:
    1. Successful access, delivery, function and retrieval of the device, and
    2. No need for additional unplanned or emergency surgery or re-intervention related to the device or access procedure
  • 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 catheterization lab)
    3. Intended performance of the device:
      1. No severe hypotension, defined as: 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
      2. Complete revascularization of all ischemia-producing lesions achieved as planned (i.e., complete planned revascularization achieved)
      3. No structural cardiac device complications
  • Rate of participants with re-hospitalizations, re-interventions, or surgery for the underlying condition (e.g. ischemic coronary artery disease) [ Time Frame: 90 days ]
  • Change in quality of life questionnaires from baseline to 90 days - EQ-5D-5L [ Time Frame: 90 days ]
    The EQ-5D-5L consists of scores from 2 methods: the descriptive system and the visual analogue scale (VAS). Questionnaire in the the descriptive system covers the following dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The VAS records the respondents' self-rated heath on a 20-cm vertical, visual analogue scale with endpoints labelled "the best health you can imagine" and "the worst health you can imagine." The descriptive system will have a summarized index value, ranging from 0 to 1, and the VAS will have a score ranging from 0 to 100. For each score, the higher the score, the better. The more positive change from baseline, the better the treatment effect.
  • Change in quality of life questionnaires from baseline to 90 days - Seattle Angina Questionnaire (SAQ) [ Time Frame: 90 days ]
    There are 5 summary scores within the SAQ, which cover the 5 domains as follows.
    1. Physical limitation
    2. Angina stability
    3. Angina frequency
    4. Treatment satisfaction
    5. Quality of life
    The range of the score of SAQ will be 0-100 for each of the 5 domains. The higher the score, the better. The more positive change from baseline, the better the treatment effect.
Original Secondary Outcome Measures  ICMJE
 (submitted: June 8, 2015)
  • All death [ Time Frame: 90 Days ]
    Death due to any cause occurring within 90 days of device use
  • 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
  • Hemodynamic measure: Maximal change in central venous pressure (CVP) from baseline [ Time Frame: 90 Days ]
    CVP as measured by direct right heart catheterization
  • Hemodynamic measure: Maximal change in mean arterial pressure (MAP) [ Time Frame: 90 Days ]
    MAP as measured by direct right heart catheterization
  • Hemodynamic measure: Maximal change in pulmonary artery pressure (PAP) from baseline [ Time Frame: 90 Days ]
    PAP as measured by direct right heart catheterization
  • Hemodynamic measure: Maximal change in pulmonary capillary wedge pressure (PCWP) from baseline [ Time Frame: 90 Days ]
    PCWP as measured by direct right heart catheterization
  • Hemodynamic measure: Maximal change in cardiac output (CO) from baseline [ Time Frame: 90 Days ]
    CO as measured by direct right heart catheterization
  • Hemodynamic measure: Maximal change in cardiac index (CI) from baseline [ Time Frame: 90 Days ]
    CI as measured by direct right heart catheterization
  • 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
  • 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
  • Duration of hospital stay [ Time Frame: Hospital Discharge ]
    Number of hospital days associated within the initial study hospitalization
  • Intensive care unit (ICU) days [ Time Frame: Hospital Discharge ]
    Number of ICU days associated within the initial study hospitalization
  • 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Supporting Patients Undergoing HIgh-Risk PCI Using a High-Flow PErcutaneous Left Ventricular Support Device (SHIELD II)
Official Title  ICMJE Supporting Patients Undergoing HIgh-Risk PCI Using a High-Flow PErcutaneous Left Ventricular Support Device (SHIELD II)
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 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.
Detailed Description

Prospective, randomized, multi-center, open-label trial of the HeartMate PHP at up to 120 sites in the US and Europe. 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 CIP versions 2-4 at 48 sites in the United States (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. and Europe

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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Coronary Artery Disease
Intervention  ICMJE
  • 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.
  • Device: Any Abiomed Impella® device approved for use in high-risk PCI
    Any Abiomed Impella® device approved for use in high-risk PCI.
Study Arms  ICMJE
  • 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 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.
    Intervention: Device: HeartMate PHP
  • Active Comparator: Any Abiomed Impella® device approved for use in high-risk PCI
    Any Abiomed Impella® Device approved for use in high-risk PCI.
    Intervention: Device: Any Abiomed Impella® device approved for use in high-risk PCI
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 7, 2019)
716
Original Estimated Enrollment  ICMJE
 (submitted: June 8, 2015)
425
Estimated Study Completion Date  ICMJE December 2021
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 CKMB 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 extra-corporeal 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/m2)
  • 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
  • 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/mm3 or INR ≥1.6 or fibrinogen ≤1.5 g/l)
  • Active systemic infection requiring treatment with antibiotics
  • 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 present of aortic stenosis (orifice area of 1.52 cm^2 or less)
  • Moderate to severe aortic insufficiency by echocardiographic assessment
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 100 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Stacy Scribner 651-756-5602 Stacy.Scribner@Abbott.com
Contact: Jessie Coe 224-668-5360 jessie.coe@abbott.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02468778
Other Study ID Numbers  ICMJE HeartMate PHP™ SHIELD II
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Abbott Medical Devices
Study Sponsor  ICMJE Abbott Medical Devices
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Jessie Coe Abbott
PRS Account Abbott Medical Devices
Verification Date October 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP