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

Overview

About this study

The HeartMate PHP System is a temporary (<6 hours) ventricular assist device indicated for use during high risk percutaneous coronary interventions (PCI) performed in elective or urgent, hemodynamically stable patients with severe coronary artery disease and depressed left ventricular ejection fraction.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria 

  • At least 18 years of age
  • Undergoing elective or urgent high risk percutaneous coronary intervention procedure and is hemodynamically stable
  • Is indicated for a revascularization of at least one new or restenotic lesion in a native coronary vessel or bypass graft 
  • A heart team that includes a Cardiac Surgeon who has seen the patient, has determined with concurrence of the Cardiac Surgeon member, that high risk PCI is the appropriate therapeutic option 
  • 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 ≤35% and at least one of the following
      • Intervention of the last patent coronary conduit
      • Intervention of an unprotected left main artery 
      • An ejection fraction of ≤35% and 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 
  • Written, signed, and dated informed consent

Exclusion Criteria

  • Emergency PCI 
  • Myocardial infarction at baseline 
  • Cardiac arrest within 24 hours of procedure requiring CPR or defibrillation 
  • Hemodynamic support with the HeartMate PHP post-PCI is anticipated 
  • Cardiogenic shock
    • Systolic blood pressure <90 mmHg for >1 hour with either cool clammy skin 
    • Oliguria 
    • Altered sensorium and cardiac index <2.2 L/min/m2
  • Mural thrombus in the left ventricle 
  • History of aortic valve replacement 
  • Documented presence of aortic stenosis with orifice area of 1.5cm2 or less
  • Moderate to severe aortic insufficiency (echocardiographic assessment of aortic insufficiency graded as 2 or higher)
  • Severe peripheral vascular disease
  • Abnormalities of the aorta that would preclude surgery, including aneurysms and significant tortuosity or calcifications
  • Is on hemodialysis 
  • Liver dysfunction with elevation of liver enzymes and
    • bilirubin levels to ≥ 3x upper limit of normal (ULN) 
    • INR (Internationalized Normalized Ratio) ≥2 
    • lactate dehydrogenase (LDH) > 2.5x ULN
  • Uncorrectable abnormal coagulation parameters (platelet count ≤75000/mm3 
  • INR ≥2.0 or fibrinogen ≤1.5 g/l)
  • Active systemic infection requiring treatment with antibiotics
  • Stroke or transient ischemic attack (TIA) within 6 month of procedure
  • Any allergy or intolerance to ionic and nonionic contrast media, anticoagulants, or antiplatelet therapy drugs that cannot be adequately premedicated 
  • Pregnant 
  • Participation in another clinical study of an investigational drug or device that has not met its primary endpoint

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status

Rochester, Minn.

Mayo Clinic principal investigator

Malcolm Bell, M.D.

Closed for enrollment

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20233705

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