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



Status:Active, not recruiting
Conditions:Peripheral Vascular Disease, Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - 100
Updated:3/24/2019
Start Date:August 2015
End Date:December 2020

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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

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 1-4 at 48 sites in the United States (U.S.) prior to January 30, 2017

- Pivotal Phase: Includes subjects to be registered under the current or 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; each operator must
treat a minimum of 1 and up to 2 subjects with the HeartMate PHP first before becoming
qualified to randomize subjects

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.

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

- Written, signed, and dated informed consent

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% 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

- Hemodynamically unstable 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

- Hemodynamic support with the HeartMate PHP post-PCI is anticipated.

- 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

- Documented presence of aortic stenosis (orifice area of 1.5cm2 or less)

- 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) ≥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 months of procedure

- Any allergy or intolerance to ionic and nonionic contrast media, anticoagulants, 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

Imaging Exclusion Criteria:

- Mural thrombus in the left ventricle

- Moderate to severe aortic insufficiency by echocardiographic assessment
We found this trial at
62
sites
60 Crittenden Blvd # 70
Rochester, New York 14642
(585) 275-2121
Principal Investigator: Frederick Ling, MD
University of Rochester The University of Rochester is one of the country's top-tier research universities....
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
Principal Investigator: Ignacio Inglessis, MD
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800 Washington St
Boston, Massachusetts 02111
(617) 636-5000
Principal Investigator: Navin Kapur, MD
Tufts Medical Center Tufts Medical Center is an internationally-respected academic medical center – a teaching...
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Boston, MA
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3550 Jerome Avenue
Bronx, New York 10467
(718) 920-4321
Principal Investigator: Ulrich Jorde, MD
Montefiore Medical Center As the academic medical center and University Hospital for Albert Einstein College...
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Bronx, NY
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5801 South Ellis Avenue
Chicago, Illinois 60637
 773.702.1234
Principal Investigator: Sandeep Nathan, MD
University of Chicago One of the world's premier academic and research institutions, the University of...
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3300 Gallows Road
Falls Church, Virginia 22042
(703) 776-4001
Principal Investigator: Alexander Truesdell, MD
Inova Fairfax Hospital Inova Fairfax Hospital, Inova's flagship hospital, is an 833-bed, nationally recognized regional...
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8700 Beverly Blvd # 8211
Los Angeles, California 90048
(1-800-233-2771)
Principal Investigator: Raj Makkar, MD
Cedars Sinai Med Ctr Cedars-Sinai is known for providing the highest quality patient care. Our...
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300 Community Drive
Manhasset, New York 11030
(516) 562-0100
Principal Investigator: Rajiv Jauhar, MD
North Shore University Hospital North Shore-LIJ Health System includes 16 award-winning hospitals and nearly 400...
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Miami, Florida 33124
(305) 284-2211
Principal Investigator: Mauricio Cohen, MD
University of Miami A private research university with more than 15,000 students from around the...
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1414 Kuhl Avenue
Orlando, Florida 32806
Principal Investigator: Vijaykumar Kasi, MD
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3400 Spruce St
Philadelphia, Pennsylvania 19104
 (215) 662-4000
Principal Investigator: Saif Anwaruddin, MD
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201 Presidents Circle
Salt Lake City, Utah 84108
801) 581-7200
Principal Investigator: Stavros Drakos, MD
University of Utah Research is a major component in the life of the U benefiting...
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Albuquerque, New Mexico 87102
Principal Investigator: Raymond Yau, MD
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Atlanta, Georgia 30309
Principal Investigator: Vivek Rajagopal, MD
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Boston, Massachusetts 02215
Principal Investigator: Roger Laham, MD
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Brooklyn, New York 11219
Principal Investigator: Robert Frankel, MD
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303 East Superior Street
Chicago, Illinois 60611
Principal Investigator: Mark Ricciardi, MD
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2139 Auburn Ave
Cincinnati, Ohio 45219
(513) 585-2000
Principal Investigator: James Kong, MD
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2600 Clifton Ave
Cincinnati, Ohio 45267
(513) 556-6000
Principal Investigator: Saad Ahmad, MD
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11100 Euclid Ave
Cleveland, Ohio 44106
(216) 844-1000
Principal Investigator: Michael Cunningham, MD
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Columbus, Ohio 43210
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Delray Beach, Florida 33431
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Detroit, Michigan 48201
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2799 W Grand Blvd
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(313) 916-2600
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2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
Principal Investigator: Manesh Patel, MD
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Germantown, Tennessee 38138
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Grand Rapids, Michigan 44506
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Houston, Texas 77030
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Houston, Texas 77030
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Indianapolis, Indiana 46290
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555 N Duke St
Lancaster, Pennsylvania 17602
(717) 544-5511
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Little Rock, Arkansas 72211
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Los Angeles, California 90033
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500 S Preston St
Louisville, Kentucky
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2450 Riverside Ave
Minneapolis, Minnesota 55454
(612) 273-3000
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475 South Street
Morristown, New Jersey 07962
Principal Investigator: Barry M Cohen, MD
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Nashville, Tennessee 37203
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New Orleans, Louisiana 70112
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1514 Jefferson Hwy.
New Orleans, Louisiana 70121
504-842-3000
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New York, New York 10032
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New York, New York 10029
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600 Gresham Dr
Norfolk, Virginia 23507
(757) 388-3000
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Sentara Norfolk General Hospital Sentara Norfolk General Hospital is recognized as the number one ranked...
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Oklahoma City, Oklahoma
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Emile St
Omaha, Nebraska 68198
(402) 559-4000
Principal Investigator: Gregory Pavlides, MD, PhD
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431 South Batavia Street
Orange, California 92868
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Phoenix, Arizona 85006
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164 Summit Ave
Providence, Rhode Island 02906
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Roslyn, New York 11576
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Sacramento, California 95819
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Saint Louis, Missouri 63110
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5300 Tallman Ave NW
Seattle, Washington 98122
(206) 782-2700
Principal Investigator: John Petersen II, MD
Swedish Medical Center Since 1910, Swedish has been the region's hallmark for excellence in health...
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1959 NE Pacific St
Seattle, Washington 98195
(206) 598-3300
Principal Investigator: William Lombardi, MD
University of Washington Medical Center University of Washington Medical Center is one of the nation's...
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Springfield, Missouri 65804
Principal Investigator: Robert F. Merritt, MD
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Tucson, Arizona 85721
(520) 621-2211
Principal Investigator: Kapildeo Lotun, MD
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Tupelo, Mississippi 38801
Principal Investigator: Barry Bertolet, MD
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Voorhees, New Jersey 08043
Principal Investigator: Steve Kernis, MD
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West Des Moines, Iowa 50266
Principal Investigator: David Mcallister, DO
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Winston-Salem, North Carolina 27615
Principal Investigator: P. Matthew Belford, MD
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Wynnewood, Pennsylvania 19096
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