SHIELD II Clinical Investigation
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.
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
- Enrollment
- 54 participants
Conditions and interventions
Conditions
Interventions
Device
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
- Jul 31, 2015
- Primary completion
- May 16, 2021
- Completion
- May 16, 2021
- Last update posted
- Jun 27, 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 27, 2022 · Synced Sep 5, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT02468778 live on ClinicalTrials.gov.