SHIELD II Clinical Investigation

NATerminatedINTERVENTIONAL
Enrollment

54

Participants

Timeline

Start Date

August 31, 2015

Primary Completion Date

May 17, 2021

Study Completion Date

May 17, 2021

Conditions
Coronary Artery Disease
Interventions
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.

Trial Locations (58)

10016

New York University, New York

10029

Mount Sinai Hospital, New York

10032

Columbia University Medical Center/New York Presbyterian Hospital, New York

10467

Montefiore Medical Center - Moses Division, The Bronx

11219

Maimonides, Brooklyn

11576

St. Francis Hospital, Roslyn

11794

Stony Brook University Medical Center, Stony Brook

14642

University of Rochester Medical Center, Rochester

15212

Allegheny Singer Research Institute, Pittsburgh

19104

Hospital of the University of Pennsylvania, Philadelphia

22042

Inova Fairfax Hospital, Falls Church

22601

Winchester Medical Center, Winchester

23507

Sentara Norfolk General Hospital, Norfolk

27157

Wake Forest University Medical Center Clinical Sciences, Winston-Salem

27705

Duke University Medical Center, Durham

30309

Piedmont Heart Institute, Atlanta

32806

Orlando Regional Medical Center, Orlando

33136

University of Miami, Miami

37203

Centennial Medical Center, Nashville

38138

The Stern Cardiovascular Foundation, Germantown

38801

North Mississippi Medical Center, Tupelo

43210

Ohio State University, Columbus

44106

University Hospitals Cleveland, Cleveland

45219

The Christ Hospital, Cincinnati

45267

University of Cincinnati, Cincinnati

48202

Henry Ford Hospital, Detroit

49503

Spectrum Health Butterworth Hospital, Grand Rapids

50266

Iowa Heart Center, West Des Moines

55455

University of Minnesota Medical Center Fairview, Minneapolis

60611

Northwestern University, Chicago

60637

University of Chicago, Chicago

63110

Barnes-Jewish Hospital, St Louis

64111

St. Luke's Hospital, Kansas City

65804

Mercy Medical Research Institute, Springfield, Springfield

67226

Cardiovascular Research Institute of Kansas, Wichita

68198

University of Nebraska Medical Center, Omaha

70112

Louisiana State University Health Sciences Center, New Orleans

70121

Ochsner Medical Center, New Orleans

73112

Integris Baptist Medical Center, Oklahoma City

75074

The Heart Hospital Baylor Plano, Plano

77030

Baylor St. Luke's Medical Center, Houston

Memorial Hermann Hospital, Houston

Methodist Hospital, Houston

78705

Seton Medical Center, Austin

85258

Scottsdale Shea Medical Center, Scottsdale

85724

University of Arizona, Tucson

87102

New Mexico Heart Institute, Albuquerque

90027

Kaiser Permanente Los Angeles Medical Center, Los Angeles

90033

USC University Hospital, Los Angeles

90048

Cedars-Sinai Medical Center, Los Angeles

92868

St.Joseph Hospital, Orange

98122

Swedish Medical Center, Seattle

98195

University of Washington Medical Center, Seattle

02111

Tufts Medical Center, Boston

02114

Massachusetts General Hospital, Boston

02215

Beth Israel Deaconness Medical Center, Boston

08043

Lourdes Cardiology Services, Voorhees Township

02906

The Miriam Hospital, Providence

Sponsors
All Listed Sponsors
lead

Abbott Medical Devices

INDUSTRY