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PHP Shield II


Title HeartMate PHP™ Coronary InterventionS in HIgh-Risk PatiEnts Using a Novel Percutaneous Left Ventricular Support Device (SHIELD II)
Therapeutic Area Cardiovascular Disease, Coronary Artery Disease, Heart Diseases
Principal Investigator Navin Kapur, MD
Min Age 18 Years
Gender All
Contact Vilma Castaneda, MD
617 636-7537

Overview

Prospective, randomized, multi-center, open-label trial of the HeartMate PHP at up to 60 sites in the US. Control device will be the Abiomed Impella® Recover® LP 2.5 Percutaneous Cardiac Support System.

Additionally, the study will include a nonrandomized roll-in phase at each site. Each site must first enroll and treat up to 3 patients in the nonrandomized roll-in phase before entering the randomized phase.

Assess the safety and efficacy of the HeartMate PHP in supporting patients with severe symptomatic coronary artery disease with diminished but stable cardiovascular function, who are undergoing elective or urgent high risk percutaneous coronary interventions (PCI) but are not candidates for coronary artery bypass graft (CABG) surgery.

Proposed Indications 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.  Nonrandomized Roll-In Phase: Up to 180 patients undergoing PCI per the Inclusion/Exclusion criteria; up to 3 roll-in patients per site.

Randomized Phase: Up to 425 patients undergoing PCI per the Inclusion/Exclusion criteria.

Data will be collected at baseline, during the PCI procedure, postprocedure, discharge, and 90 days post device removal.

All patients will have a follow-up visit at 90 days post-device removal.

Study Details

Inclusion Criteria

  • Patient is undergoing elective or urgent high risk PCI procedure and is hemodynamically stable
  • A heart team, including a cardiac surgeon, has determined high risk PCI is an acceptable 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, 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
  • Myocardial infarction at baseline defined as:

    ST Elevation MI (STEMI):
    • Subject has clinical symptoms and/or ECG changes (new pathological Q waves in 2 contiguous leads) consistent with acute ST elevation MI (STEMI) within 72 hours prior to the index procedure.

    Non-STEMI:
    • Hemodynamically unstable with biomarker elevation (CK-MB or Troponin >1x URL) and/or no evidence of at least 1 consecutive troponin or CK-MB value trending downward from previous value

  • Documented presence of aortic stenosis (orifice area of 1.5cm2 or less)

Study Requirements

Before the PCI Procedure:

Up to two weeks prior to study entry the following tests will be performed:
  • Blood draws (2 tablespoons) Physical exam (including measurements of your height and weight, blood pressure, heart rate, temperature, and breathing)Hemodynamic measurements (measurements of blood flow and pressure during the procedure) A small tube will be placed into the right side of your heart and the arteries leading to your lungs before the PCI procedure in order to take the hemodynamic measurements. The tube will be removed after the PCI procedure.
  • Echocardiogram
  • Cardiac operative assessment
  • You will be asked about previous medical conditions
  • You will also be asked to complete questionnaires about how you are feeling
  • These tasks will be completed in about 3 hours
Procedure

  • Hemodynamic measurements (measurements of blood flow and pressure during the procedure) A small tube will be placed into the right side of your heart and the arteries leading to your lungs before the PCI procedure in order to take the hemodynamic measurements. The tube will be removed after the PCI procedure.
  • Cardiovascular circulation assessment
  • Hemodynamic measurements – during the procedure hemodynamics will be measured two times: (1) once while the device is on and (2) once right after the device is turned off
  • Neurological assessment if clinically required
After the PCI Procedure:

Within the 48 hours following device removal the following tests will be performed:
  • Blood draws (2 tablespoons)
  • Measurement of your blood pressure, heart rate, temperature, and breathing
  • Hemodynamic measurements – 10- 30 minutes after the device is turned off
  • Echocardiogram
  • You will also be asked how you are feeling
  • This section will be completed in about 2 hours.
Discharge

  • Physical Exam (including measurements of your blood pressure, heart rate, temperature, and breathing)Blood draws (2 tablespoons) (if discharged more than 24 hours after your post-PCI procedure blood draw)Echocardiogram (if discharged more than 24 hours after your post-PCI procedure echocardiogram)
  • You will also be asked how you are feeling
  • This section will be completed in about 2 hours.
  • If we suspect that something may be wrong with a valve in your heart after device removal, extra echocardiograms may be performed as part of your standard of care and the study will collect the information.
Post Discharge

At the ninety (90) Days after Device Removal visit The following tests will be performed
  • Physical exam
  • Echocardiogram
  • You will also be asked to complete questionnaires about how you are feeling
  • if you have had any adverse events since the procedure and undergo an echocardiogram of your heart.
After this ninety (90) day visit, your participation in the study is completed.