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Terminated Not applicable Interventional Results available

SHIELD II Clinical Investigation

ClinicalTrials.gov ID: NCT02468778

Public ClinicalTrials.gov record NCT02468778. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 21, 2026, 12:42 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT02468778
Recruitment status
Terminated
Study type
Interventional
Phase
Not applicable
Lead sponsor
Abbott Medical Devices
Industry
Enrollment
54 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years to 100 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Aug 2015 (Actual)
Primary completion
May 17, 2021 (Actual)
Completion
May 17, 2021 (Actual)
Last update posted
Jun 28, 2022

2015 – 2021

United States locations

U.S. sites
58
U.S. states
26
U.S. cities
46
Facility City State ZIP Site status
Scottsdale Shea Medical Center Scottsdale Arizona 85258 —
University of Arizona Tucson Arizona 85724 —
Kaiser Permanente Los Angeles Medical Center Los Angeles California 90027 —
USC University Hospital Los Angeles California 90033 —
Cedars-Sinai Medical Center Los Angeles California 90048 —
St.Joseph Hospital Orange California 92868 —
University of Miami Miami Florida 33136 —
Orlando Regional Medical Center Orlando Florida 32806 —
Piedmont Heart Institute Atlanta Georgia 30309 —
Northwestern University Chicago Illinois 60611 —
University of Chicago Chicago Illinois 60637 —
Iowa Heart Center West Des Moines Iowa 50266 —
Cardiovascular Research Institute of Kansas Wichita Kansas 67226 —
Louisiana State University Health Sciences Center New Orleans Louisiana 70112 —
Ochsner Medical Center New Orleans Louisiana 70121 —
Tufts Medical Center Boston Massachusetts 02111 —
Massachusetts General Hospital Boston Massachusetts 02114 —
Beth Israel Deaconness Medical Center Boston Massachusetts 02215 —
Henry Ford Hospital Detroit Michigan 48202 —
Spectrum Health Butterworth Hospital Grand Rapids Michigan 49503 —
University of Minnesota Medical Center Fairview Minneapolis Minnesota 55455 —
North Mississippi Medical Center Tupelo Mississippi 38801 —
St. Luke's Hospital Kansas City Missouri 64111 —
Mercy Medical Research Institute, Springfield Springfield Missouri 65804 —
Barnes-Jewish Hospital St Louis Missouri 63110 —
University of Nebraska Medical Center Omaha Nebraska 68198 —
Lourdes Cardiology Services Voorhees Township New Jersey 08043 —
New Mexico Heart Institute Albuquerque New Mexico 87102 —
Maimonides Brooklyn New York 11219 —
New York University New York New York 10016 —
Mount Sinai Hospital New York New York 10029 —
Columbia University Medical Center/New York Presbyterian Hospital New York New York 10032 —
University of Rochester Medical Center Rochester New York 14642 —
St. Francis Hospital Roslyn New York 11576 —
Stony Brook University Medical Center Stony Brook New York 11794 —
Montefiore Medical Center - Moses Division The Bronx New York 10467 —
Duke University Medical Center Durham North Carolina 27705 —
Wake Forest University Medical Center Clinical Sciences Winston-Salem North Carolina 27157 —
The Christ Hospital Cincinnati Ohio 45219 —
University of Cincinnati Cincinnati Ohio 45267 —
University Hospitals Cleveland Cleveland Ohio 44106 —
Ohio State University Columbus Ohio 43210 —
Integris Baptist Medical Center Oklahoma City Oklahoma 73112 —
Hospital of the University of Pennsylvania Philadelphia Pennsylvania 19104 —
Allegheny Singer Research Institute Pittsburgh Pennsylvania 15212 —
The Miriam Hospital Providence Rhode Island 02906 —
The Stern Cardiovascular Foundation Germantown Tennessee 38138 —
Centennial Medical Center Nashville Tennessee 37203 —
Seton Medical Center Austin Texas 78705 —
Baylor St. Luke's Medical Center Houston Texas 77030 —
Memorial Hermann Hospital Houston Texas 77030 —
Methodist Hospital Houston Texas 77030 —
The Heart Hospital Baylor Plano Plano Texas 75074 —
Inova Fairfax Hospital Falls Church Virginia 22042 —
Sentara Norfolk General Hospital Norfolk Virginia 23507 —
Winchester Medical Center Winchester Virginia 22601 —
Swedish Medical Center Seattle Washington 98122 —
University of Washington Medical Center Seattle Washington 98195 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT02468778, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jun 28, 2022 · Synced Oct 21, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT02468778 live on ClinicalTrials.gov.

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