Last updated on December 2016

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


Brief description of study

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.

Detailed Study 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.

Clinical Study Identifier: NCT02468778

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Timothy Byrne, MD

Arizona Heart Hospital
Phoenix, AZ United States
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Kapildeo Lotun, MD

University of Arizona
Tucson, AZ United States
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David Mego, MD

Arkansas Heart Hospital
Little Rock, AR United States
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Brian Kolski, MD

St.Joseph Hospital
Costa Mesa, CA United States
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Ray Matthews, MD

USC University Hospital
Los Angeles, CA United States
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Joseph Kozina, MD

Mercy General Hospital
Sacramento, CA United States
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Brijeshwar Maini, MD

Delray Medical Center
Delray Beach, FL United States
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Larry Crisco, MD

Memorial Hospital Jacksonville
Jacksonville, FL United States
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Mauricio Cohen, MD

University of Miami
Miami, FL United States
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Vijaykumar Kasi, MD

Orlando Regional Medical Center
Orlando, FL United States
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Vivek Rajagopal, MD

Piedmont Heart Institute
Atlanta, GA United States
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Mark Ricciardi, MD

Northwestern University
Chicago, IL United States
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Sandeep Nathan, MD

University of Chicago
Chicago, IL United States
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James Hermiller, MD

St. Vincent Medical Group
Indianapolis, IN United States
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David Mcallister, MD

Iowa Heart Center
West Des Moines, IA United States
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Mark Slaughter, MD

University of Louisville
Louisville, KY United States
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Murtuza Ali, MD

Louisiana State University
New Orleans, LA United States
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Navin Kapur, MD

Tufts / New England Medical Center
Boston, MA United States
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Ignacio Inglessis, MD

Massachusetts General Hospital
Boston, MA United States
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Roger Laham, MD

Beth Israel Deaconness Medical Center
Boston, MA United States
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Theodore Schreiber, MD

DMC - Harper University Hospital
Detroit, MI United States
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Akshay Khandelwal, MD

Henry Ford Hospital
Detroit, MI United States
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David Wohns, MD

Spectrum Health Butterworth Hospital
Grand Rapids, MI United States
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Ganesh Raveendran, MD

University of Minnesota Medical Center Fairview
Minneapolis, MN United States
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Malcolm Bell, MD

Mayo Clinic
Rochester, MN United States
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Barry Bertolet, MD

North Mississippi Medical Center
Tupelo, MS United States
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Sunil Prasad, MD

Mercy Medical Research Institute, Springfield
Springfield, MO United States
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Jasvinder Singh, MD

Barnes-Jewish Hospital
St. Louis, MO United States
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Gregory Pavlides, MD

University of Nebraska Medical Center
Omaha, NE United States
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Steve Kernis, MD

Lourdes Cardiology Services
Voorhees, NJ United States
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Raymond Yau, MD

New Mexico Heart Institute
Albuquerque, NM United States
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Ulrich Jorde, MD

Montefiore Medical Center
Bronx, NY United States
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Robert Frankel, MD

Maimonides
Brooklyn, NY United States
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Rajiv Jauhar, MD

North Shore University Hospital
Manhasset, NY United States
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Samin Sharma, MD

Mount Sinai Hospital
New York, NY United States
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Ajay J Kirtane, MD

Columbia University Medical Center/New York Presbyterian Hospital
New York, NY United States
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Frederick Ling, MD

University of Rochester
Rochester, NY United States
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Richard Shlofmitz, MD

St. Francis Hospital
Roslyn, NY United States
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Manesh Patel, MD

Duke University Medical Center
Durham, NC United States
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P. Matthew Belford, MD

Wake Forest University Medical Center Clinical Sciences
Winston-Salem, NC United States
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Satya Shreenivas, MD

University of Cincinnati
Cincinnati, OH United States
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James Kong, MD

The Christ Hospital
Cincinnati, OH United States
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Sahil Parikh, MD

University Hospitals Cleveland
Cleveland, OH United States
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Scott Lilly, MD

Ohio State University Medical Center
Columbus, OH United States
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George Chrysant, MD

Integris Baptist Medical Center
Oklahoma City, OK United States
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Rupal Dumasia, MD

Lancaster General Hospital
Lancaster, PA United States
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Gene Chang, MD

Hospital of the University of Pennsylvania
Philadelphia, PA United States
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David Lasorda, MD

Allegheny Singer Research Institute
Pittsburgh, PA United States
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Raj Makkar, MD

Cedars-Sinai Medical Center
Wynnewood, PA United States
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Eric Gnall, MD

Lankenau Medical Center
Wynnewood, PA United States
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Paul Gordon, MD

The Miriam Hospital
Providence, RI United States
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Basil Paulus, MD

The Stern Cardiovascular Foundation
Germantown, TN United States
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Taral Patel, MD

Centennial Medical Center
Nashville, TN United States
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Andrew Civitello, MD, FACC

Baylor St. Luke's Medical Center
Houston, TX United States
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Marwan Jumean, MD

Memorial Hermann Hospital
Houston, TX United States
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Neal Kleiman, MD

Methodist Hospital
Houston, TX United States
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Stavros Drakos, MD

University of Utah
Salt Lake City, UT United States
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Alexander Truesdell, MD

Inova Fairfax Hospital
Falls Church, VA United States
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Deepak Talreja, MD

Sentara Norfolk General Hospital
Norfolk, VA United States
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John Peterson, MD

Swedish Medical Center
Seattle, WA United States
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William Lombardi, MD

University of Washington Medical Center
Seattle, WA United States
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