SHIELD II Clinical Investigation

Not Applicable

Terminated

Conditions: Coronary Artery Disease

Interventions: Device: HeartMate PHP
Device: Any Abiomed Impella® device approved for use in high-risk PCI

Registration Number: NCT02468778

Lead Sponsor: Abbott Medical Devices

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 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.

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 54

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 & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HeartMate PHP (Roll-in)	HeartMate PHP	Participants who receive a HeartMate PHP device without randomisation will be included in this arm
HeartMate PHP (Randomised)	HeartMate PHP	Participants who receive a HeartMate PHP device after randomisation will be included in this arm
Any Abiomed Impella® (Randomised)	Any Abiomed Impella® device approved for use in high-risk PCI	Participants who receive any Abiomed Impella® Device approved for use in high-risk PCI after randomisation will be included in this arm

Primary Outcome Measures

Name	Time	Method
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	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.

Secondary Outcome Measures

Name	Time	Method

Trial Locations

Locations (58): North Mississippi Medical Center
🇺🇸
Tupelo, Mississippi, United States
Ochsner Medical Center
🇺🇸
New Orleans, Louisiana, United States
Henry Ford Hospital
🇺🇸
Detroit, Michigan, United States
Mount Sinai Hospital
🇺🇸
New York, New York, United States
Orlando Regional Medical Center
🇺🇸
Orlando, Florida, United States
Iowa Heart Center
🇺🇸
West Des Moines, Iowa, United States
New Mexico Heart Institute
🇺🇸
Albuquerque, New Mexico, United States
Spectrum Health Butterworth Hospital
🇺🇸
Grand Rapids, Michigan, United States
St. Francis Hospital
🇺🇸
Roslyn, New York, United States
Louisiana State University Health Sciences Center
🇺🇸
New Orleans, Louisiana, United States
New York University
🇺🇸
New York, New York, United States
Inova Fairfax Hospital
🇺🇸
Falls Church, Virginia, United States
Maimonides
🇺🇸
Brooklyn, New York, United States
Cedars-Sinai Medical Center
🇺🇸
Los Angeles, California, United States
Piedmont Heart Institute
🇺🇸
Atlanta, Georgia, United States
Northwestern University
🇺🇸
Chicago, Illinois, United States
University of Chicago
🇺🇸
Chicago, Illinois, United States
University Hospitals Cleveland
🇺🇸
Cleveland, Ohio, United States
Ohio State University
🇺🇸
Columbus, Ohio, United States
Tufts Medical Center
🇺🇸
Boston, Massachusetts, United States
Massachusetts General Hospital
🇺🇸
Boston, Massachusetts, United States
Duke University Medical Center
🇺🇸
Durham, North Carolina, United States
The Christ Hospital
🇺🇸
Cincinnati, Ohio, United States
University of Cincinnati
🇺🇸
Cincinnati, Ohio, United States
Baylor St. Luke's Medical Center
🇺🇸
Houston, Texas, United States
Memorial Hermann Hospital
🇺🇸
Houston, Texas, United States
Methodist Hospital
🇺🇸
Houston, Texas, United States
Swedish Medical Center
🇺🇸
Seattle, Washington, United States
University of Washington Medical Center
🇺🇸
Seattle, Washington, United States
Scottsdale Shea Medical Center
🇺🇸
Scottsdale, Arizona, United States
Kaiser Permanente Los Angeles Medical Center
🇺🇸
Los Angeles, California, United States
USC University Hospital
🇺🇸
Los Angeles, California, United States
St.Joseph Hospital
🇺🇸
Orange, California, United States
St. Luke's Hospital
🇺🇸
Kansas City, Missouri, United States
Lourdes Cardiology Services
🇺🇸
Voorhees, New Jersey, United States
Columbia University Medical Center/New York Presbyterian Hospital
🇺🇸
New York, New York, United States
Hospital of the University of Pennsylvania
🇺🇸
Philadelphia, Pennsylvania, United States
Wake Forest University Medical Center Clinical Sciences
🇺🇸
Winston-Salem, North Carolina, United States
Allegheny Singer Research Institute
🇺🇸
Pittsburgh, Pennsylvania, United States
Seton Medical Center
🇺🇸
Austin, Texas, United States
University of Arizona
🇺🇸
Tucson, Arizona, United States
The Miriam Hospital
🇺🇸
Providence, Rhode Island, United States
University of Miami
🇺🇸
Miami, Florida, United States
University of Rochester Medical Center
🇺🇸
Rochester, New York, United States
Mercy Medical Research Institute, Springfield
🇺🇸
Springfield, Missouri, United States
Stony Brook University Medical Center
🇺🇸
Stony Brook, New York, United States
Beth Israel Deaconness Medical Center
🇺🇸
Boston, Massachusetts, United States
Barnes-Jewish Hospital
🇺🇸
Saint Louis, Missouri, United States
Cardiovascular Research Institute of Kansas
🇺🇸
Wichita, Kansas, United States
University of Nebraska Medical Center
🇺🇸
Omaha, Nebraska, United States
The Stern Cardiovascular Foundation
🇺🇸
Germantown, Tennessee, United States
University of Minnesota Medical Center Fairview
🇺🇸
Minneapolis, Minnesota, United States
Montefiore Medical Center - Moses Division
🇺🇸
Bronx, New York, United States
Integris Baptist Medical Center
🇺🇸
Oklahoma City, Oklahoma, United States
Centennial Medical Center
🇺🇸
Nashville, Tennessee, United States
Sentara Norfolk General Hospital
🇺🇸
Norfolk, Virginia, United States
The Heart Hospital Baylor Plano
🇺🇸
Plano, Texas, United States
Winchester Medical Center
🇺🇸
Winchester, Virginia, United States