SHIELD II Clinical Investigation

NCT02468778 | Terminated Results DMC FDA Device

• 1 other identifier: SJM-CIP-10148 Ver. J
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 58

Brief Summary

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.

Conditions

Coronary Artery Disease

Keywords

HeartMate PHP; High Risk PCI; Mechanical circulatory support device; MCS; Abbott; SJM-CIP-10148

Outcome Measures

Primary Outcomes (1)

• Rate of Participants With Composite of Cardiovascular Death, Myocardial Infarction, Stroke, Any Unplanned Repeat Revascularization (PCI/CABG), Bleeding (BARC 3/5) up to 14 Days Post-device Removal, Severe Hypotension, and Change in Aortic Insufficiency

  The primary endpoint, including the following components representing important safety and effectiveness endpoints will be evaluated using the difference in event rates in the ITT population. * Cardiovascular Death * Myocardial infarction (MI) * Stroke * Any unplanned repeat revascularization (PCI or CABG) * Bleeding (BARC 3 or 5) up to 14 days post-device removal * Severe hypotension, defined as: systolic blood pressure (SBP) or augmented diastolic pressure (whichever is greater) \<90 mmHg while on device support requiring (1) more than one administration of OR (2) continuous infusion of inotropic/pressor medications to restore hemodynamics * Change in aortic insufficiency from baseline to 90 days by echocardiographic assessment.

  90 Days

Study Arms (3)

HeartMate PHP (Roll-in)

EXPERIMENTAL

Participants who receive a HeartMate PHP device without randomisation will be included in this arm

Device: HeartMate PHP

HeartMate PHP (Randomised)

EXPERIMENTAL

Participants who receive a HeartMate PHP device after randomisation will be included in this arm

Device: HeartMate PHP

Any Abiomed Impella® (Randomised)

ACTIVE COMPARATOR

Participants who receive any Abiomed Impella® Device approved for use in high-risk PCI after randomisation will be included in this arm

Device: Any Abiomed Impella® device approved for use in high-risk PCI

Interventions

HeartMate PHP DEVICE

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.

HeartMate PHP (Randomised); HeartMate PHP (Roll-in)

Any Abiomed Impella® device approved for use in high-risk PCI DEVICE

Any Abiomed Impella® device approved for use in high-risk PCI.

Any Abiomed Impella® (Randomised)

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• At least 18 years of age
• Subject is undergoing elective or urgent high-risk PCI procedure and is hemodynamically stable
• Subject 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
• Subject must provide written informed consent prior to any clinical investigation related procedure
• 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% by echocardiographic assessment 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

You may not qualify if:

• Emergency PCI
• Any prior coronary revascularization within the last 6 months
• Any 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 CK-MB 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
• Any use of a mechanical circulatory support device within 14 days prior to the index procedure (Note: Subjects must be hemodynamically stable without any hemodynamic support to be eligible for this clinical investigation.)
• Hemodynamic support with a mechanical circulatory support device (e.g.,the HeartMate PHP, Impella, intra-aortic balloon pump (IABP), or extracorporeal membrane oxygenation (ECMO)), post-PCI is anticipated
• Any condition that requires discontinuation of antiplatelet and/or anticoagulant therapy within 90 days following the index procedure (e.g., planned noncardiac surgery)
• Any use of vasopressors or inotropes within 24 hours prior to the index procedure
• 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/m\^2)
• History of aortic valve replacement or repair
• 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 (If the investigator is unsure of the presence or severity of the peripheral vascular diseases for study device access, an appropriate imaging assessment (e.g., duplex ultrasound, angiogram or computerized tomography) should be performed to verify the access before randomization.)
• 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) ≥1.6 or lactate dehydrogenase (LDH) \> 2.5X ULN

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (58)

Scottsdale Shea Medical Center

Scottsdale, Arizona, 85258, United States

Location

University of Arizona

Tucson, Arizona, 85724, United States

Location

Kaiser Permanente Los Angeles Medical Center

Los Angeles, California, 90027, United States

Location

USC University Hospital

Los Angeles, California, 90033, United States

Location

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

St.Joseph Hospital

Orange, California, 92868, United States

Location

University of Miami

Miami, Florida, 33136, United States

Location

Orlando Regional Medical Center

Orlando, Florida, 32806, United States

Location

Piedmont Heart Institute

Atlanta, Georgia, 30309, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

University of Chicago

Chicago, Illinois, 60637, United States

Location

Iowa Heart Center

West Des Moines, Iowa, 50266, United States

Location

Cardiovascular Research Institute of Kansas

Wichita, Kansas, 67226, United States

Location

Louisiana State University Health Sciences Center

New Orleans, Louisiana, 70112, United States

Location

Ochsner Medical Center

New Orleans, Louisiana, 70121, United States

Location

Tufts Medical Center

Boston, Massachusetts, 02111, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Beth Israel Deaconness Medical Center

Boston, Massachusetts, 02215, United States

Location

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

Spectrum Health Butterworth Hospital

Grand Rapids, Michigan, 49503, United States

Location

University of Minnesota Medical Center Fairview

Minneapolis, Minnesota, 55455, United States

Location

North Mississippi Medical Center

Tupelo, Mississippi, 38801, United States

Location

St. Luke's Hospital

Kansas City, Missouri, 64111, United States

Location

Mercy Medical Research Institute, Springfield

Springfield, Missouri, 65804, United States

Location

Barnes-Jewish Hospital

St Louis, Missouri, 63110, United States

Location

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location

Lourdes Cardiology Services

Voorhees Township, New Jersey, 08043, United States

Location

New Mexico Heart Institute

Albuquerque, New Mexico, 87102, United States

Location

Maimonides

Brooklyn, New York, 11219, United States

Location

New York University

New York, New York, 10016, United States

Location

Mount Sinai Hospital

New York, New York, 10029, United States

Location

Columbia University Medical Center/New York Presbyterian Hospital

New York, New York, 10032, United States

Location

University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

St. Francis Hospital

Roslyn, New York, 11576, United States

Location

Stony Brook University Medical Center

Stony Brook, New York, 11794, United States

Location

Montefiore Medical Center - Moses Division

The Bronx, New York, 10467, United States

Location

Duke University Medical Center

Durham, North Carolina, 27705, United States

Location

Wake Forest University Medical Center Clinical Sciences

Winston-Salem, North Carolina, 27157, United States

Location

The Christ Hospital

Cincinnati, Ohio, 45219, United States

Location

University of Cincinnati

Cincinnati, Ohio, 45267, United States

Location

University Hospitals Cleveland

Cleveland, Ohio, 44106, United States

Location

Ohio State University

Columbus, Ohio, 43210, United States

Location

Integris Baptist Medical Center

Oklahoma City, Oklahoma, 73112, United States

Location

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Allegheny Singer Research Institute

Pittsburgh, Pennsylvania, 15212, United States

Location

The Miriam Hospital

Providence, Rhode Island, 02906, United States

Location

The Stern Cardiovascular Foundation

Germantown, Tennessee, 38138, United States

Location

Centennial Medical Center

Nashville, Tennessee, 37203, United States

Location

Seton Medical Center

Austin, Texas, 78705, United States

Location

Baylor St. Luke's Medical Center

Houston, Texas, 77030, United States

Location

Memorial Hermann Hospital

Houston, Texas, 77030, United States

Location

Methodist Hospital

Houston, Texas, 77030, United States

Location

The Heart Hospital Baylor Plano

Plano, Texas, 75074, United States

Location

Inova Fairfax Hospital

Falls Church, Virginia, 22042, United States

Location

Sentara Norfolk General Hospital

Norfolk, Virginia, 23507, United States

Location

Winchester Medical Center

Winchester, Virginia, 22601, United States

Location

Swedish Medical Center

Seattle, Washington, 98122, United States

Location

University of Washington Medical Center

Seattle, Washington, 98195, United States

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Results Point of Contact

• Title: Sandeep Pingle, Principal Clinical Scientist
• Organization: Abbott Vascular

Sandeep.pingle1@abbott.com

408-845-2111

Study Officials

• Jessie Coe

  Abbott

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2015
• First Posted: June 11, 2015
• Study Start: August 1, 2015
• Primary Completion: May 17, 2021
• Study Completion: May 17, 2021
• Last Updated: June 28, 2022
• Results First Posted: June 28, 2022

Record last verified: 2022-06

Locations

US (58)