SHIELD II Clinical Investigation

Coronary Artery Disease Clinical Trial

— SHIELD II  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02468778
• Other study ID #: SJM-CIP-10148 Ver. J
• Status: Terminated
• Phase: N/A
• Start date: August 2015
• Est. completion date: May 17, 2021

Study information

• Verified date: June 2022
• Source: Abbott Medical Devices
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Prospective, randomized, multi-center, open-label trial of the HeartMate PHP at up to 120 sites in the United States (U.S.). Control device will be any Abiomed Impella device approved for use in high-risk PCI.

This clinical investigation is divided into two phases, a feasibility phase and a pivotal phase.

• Feasibility Phase: Includes 75 roll-in and 120 randomized subjects registered under the clinical investigational plan (CIP) versions 2-4 at 48 sites in the U.S. prior to January 30, 2017

• Pivotal Phase: Includes subjects to be registered under Version F or a later version of the CIP at up to 120 sites in the U.S.

Non-randomized Roll-in Cohort: Up to 480 subjects with the HeartMate PHP.

Randomized Cohort: A minimum of 473 and a maximum of 716 subjects will be randomized in a 2:1 ratio to the HeartMate PHP and Impella.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 54
• Est. completion date: May 17, 2021
• Est. primary completion date: May 17, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

• 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

Imaging Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

• Abnormal coagulation parameters (platelet count =75000/mm^3 or INR =1.6 or fibrinogen =1.5 g/l)

• Active systemic infection requiring treatment with antibiotics

• Subject had active COVID-19 symptoms and/or a positive test result within the prior 2 months

• Stroke or transient ischemic attack (TIA) within 6 months of procedure

• Any allergy or intolerance to ionic and nonionic contrast media, anticoagulants (including heparin), or antiplatelet therapy drugs that cannot be adequately premedicated

• Subject is pregnant (For a female subject of childbearing potential, a pregnancy test must be performed within 14 days (=14 days) prior to the index procedure per site standard test)

• Participation in another clinical study of an investigational drug or device that has not met its primary endpoint

• Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with followup requirements, or impact the scientific soundness of the clinical investigation results

• Life expectancy <1 year

Imaging Exclusion Criteria:

• Mural thrombus in the left ventricle

• Documented presence of aortic stenosis (orifice area of 1.5 cm^2 or less)

• Moderate to severe aortic insufficiency by echocardiographic assessment

Related Conditions & MeSH terms

• Coronary Artery Disease

Intervention

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

Locations

Country	Name	City	State
United States	New Mexico Heart Institute	Albuquerque	New Mexico
United States	Piedmont Heart Institute	Atlanta	Georgia
United States	Seton Medical Center	Austin	Texas
United States	Beth Israel Deaconness Medical Center	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Tufts Medical Center	Boston	Massachusetts
United States	Montefiore Medical Center - Moses Division	Bronx	New York
United States	Maimonides	Brooklyn	New York
United States	Northwestern University	Chicago	Illinois
United States	University of Chicago	Chicago	Illinois
United States	The Christ Hospital	Cincinnati	Ohio
United States	University of Cincinnati	Cincinnati	Ohio
United States	University Hospitals Cleveland	Cleveland	Ohio
United States	Ohio State University	Columbus	Ohio
United States	Henry Ford Hospital	Detroit	Michigan
United States	Duke University Medical Center	Durham	North Carolina
United States	Inova Fairfax Hospital	Falls Church	Virginia
United States	The Stern Cardiovascular Foundation	Germantown	Tennessee
United States	Spectrum Health Butterworth Hospital	Grand Rapids	Michigan
United States	Baylor St. Luke's Medical Center	Houston	Texas
United States	Memorial Hermann Hospital	Houston	Texas
United States	Methodist Hospital	Houston	Texas
United States	St. Luke's Hospital	Kansas City	Missouri
United States	Cedars-Sinai Medical Center	Los Angeles	California
United States	Kaiser Permanente Los Angeles Medical Center	Los Angeles	California
United States	USC University Hospital	Los Angeles	California
United States	University of Miami	Miami	Florida
United States	University of Minnesota Medical Center Fairview	Minneapolis	Minnesota
United States	Centennial Medical Center	Nashville	Tennessee
United States	Louisiana State University Health Sciences Center	New Orleans	Louisiana
United States	Ochsner Medical Center	New Orleans	Louisiana
United States	Columbia University Medical Center/New York Presbyterian Hospital	New York	New York
United States	Mount Sinai Hospital	New York	New York
United States	New York University	New York	New York
United States	Sentara Norfolk General Hospital	Norfolk	Virginia
United States	Integris Baptist Medical Center	Oklahoma City	Oklahoma
United States	University of Nebraska Medical Center	Omaha	Nebraska
United States	St.Joseph Hospital	Orange	California
United States	Orlando Regional Medical Center	Orlando	Florida
United States	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania
United States	Allegheny Singer Research Institute	Pittsburgh	Pennsylvania
United States	The Heart Hospital Baylor Plano	Plano	Texas
United States	The Miriam Hospital	Providence	Rhode Island
United States	University of Rochester Medical Center	Rochester	New York
United States	St. Francis Hospital	Roslyn	New York
United States	Barnes-Jewish Hospital	Saint Louis	Missouri
United States	Scottsdale Shea Medical Center	Scottsdale	Arizona
United States	Swedish Medical Center	Seattle	Washington
United States	University of Washington Medical Center	Seattle	Washington
United States	Mercy Medical Research Institute, Springfield	Springfield	Missouri
United States	Stony Brook University Medical Center	Stony Brook	New York
United States	University of Arizona	Tucson	Arizona
United States	North Mississippi Medical Center	Tupelo	Mississippi
United States	Lourdes Cardiology Services	Voorhees	New Jersey
United States	Iowa Heart Center	West Des Moines	Iowa
United States	Cardiovascular Research Institute of Kansas	Wichita	Kansas
United States	Winchester Medical Center	Winchester	Virginia
United States	Wake Forest University Medical Center Clinical Sciences	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Medical Devices

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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