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HeartMate PHP™ CE Mark Clinical Investigation Plan (HM PHP CE Mark)

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ClinicalTrials.gov Identifier: NCT02156609
Recruitment Status : Completed
First Posted : June 5, 2014
Last Update Posted : April 11, 2016
Sponsor:
Collaborator:
St. Jude Medical
Information provided by (Responsible Party):
St. Jude Medical ( Thoratec Corporation )

Brief Summary:
The HeartMate PHP is a catheter-based pump designed to provide partial left heart circulatory support. The study will assess the safety and performance of the HeartMate PHP in supporting patients who are hemodynamically unstable, or at risk of being hemodynamically unstable, while undergoing percutaneous coronary interventions (PCI), such as coronary stent placement.

Condition or disease Intervention/treatment Phase
High Risk Percutaneous Coronary Intervention Device: Percutaneous ventricular support with the HeartMate PHP Not Applicable

Detailed Description:
The HeartMate PHP (percutaneous heart pump) is a catheter-based axial flow pump designed to provide partial left ventricular circulatory support. The primary objective of this prospective, nonrandomized, multi-center, open-label trial is to assess the safety and performance of the HeartMate PHP in supporting patients who are hemodynamically unstable, or at risk of being hemodynamically unstable, while undergoing percutaneous coronary interventions (PCI).

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: HeartMate PHP™ CE Mark Clinical Investigation Plan
Study Start Date : June 2014
Actual Primary Completion Date : November 2015
Actual Study Completion Date : December 2015

Arm Intervention/treatment
Experimental: Percutaneous coronary intervention
Percutaneous ventricular support with the HeartMate PHP during high risk percutaneous coronary intervention
Device: Percutaneous ventricular support with the HeartMate PHP
The HeartMate PHP device will be inserted percutaneously prior to the start of high risk coronary interventions (complex disease, reduced ejection fraction, etc.) to provide hemodynamic support,




Primary Outcome Measures :
  1. Primary Endpoint [ Time Frame: Post procedure or at hospital discharge (whichever is longer), 30 days post procedure ]

    Primary Performance Endpoint:

    Freedom from hemodynamic compromise during PCI procedure defined as: Mean Arterial Pressure (MAP) not falling below 60mm Hg for more than 10 minutes during the PCI procedure and additional pressor medication is not required.

    Primary Endpoint will be evaluated at:

    • Post procedure or at hospital discharge (whichever is longer)
    • 30 days post procedure

  2. Composite of Major Adverse Events (MAE) [ Time Frame: Post procedure or at hospital discharge (whichever is longer), 30 days post procedure ]

    Primary Safety Endpoint:

    Composite of Major Adverse Events (MAE):

    • device-related cardiac death,
    • new Q wave myocardial infarction,
    • surgical intervention due to device complication or malfunction,
    • device-related access site complication requiring intervention or device-related limb ischemia,
    • cerebral vascular accident (CVA),
    • new or worsening aortic valve insufficiency,
    • major bleeding complication (BARC 3 or >),
    • severe hypotension

    Primary Endpoint will be evaluated at:

    • Post procedure or at hospital discharge (whichever is longer)
    • 30 days post procedure


Secondary Outcome Measures :
  1. Secondary Endpoint [ Time Frame: Post procedure or at hospital discharge (whichever is longer), 30 days post procedure ]

    Efficacy of hemodynamic support as measured by:

    • Maximal decrease in cardiac power output (CPO) from baseline
    • Changes in central venous pressure from baseline (CVP)
    • Changes in pulmonary artery pressure from baseline (PAP)
    • Changes in pulmonary capillary wedge pressure from baseline (PCWP)
    • Changes in cardiac output from baseline (CO)
    • Changes in cardiac index from baseline (CI)

  2. Major Adverse Event Composites [ Time Frame: Post procedure or at hospital discharge (whichever is longer), 30 days post procedure ]
    Individual components of the major adverse event composites



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • At least 18 years of age.
  • Patient presents with a non-emergent need for complex PCI with:

    1. an ejection fraction of ≤35% requiring hemodynamic support during the procedure, AND
    2. the heart team has determined that the patient is not an optimal surgical candidate, OR the patient elects not to undergo surgery
  • Written, signed, and dated informed consent

Exclusion Criteria:

  • Emergent PCI
  • ST elevation myocardial infarction within 7 days of procedure
  • Cardiac arrest within 7 days of procedure requiring CPR or defibrillation
  • Hemodynamic support with the HeartMate PHP post-PCI is anticipated
  • Cardiogenic shock (SBP <90 mmHg for >1 hour with either cool clammy skin OR oliguria OR altered sensorium OR cardiac index <2.2 L/min/m2)
  • Mural thrombus in the left ventricle
  • History of aortic valve replacement
  • Documented presence of aortic stenosis (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
  • Planned use of rotablator or atherectomy during the procedure
  • Serum creatinine > 3.5mg/dL within 7 days of procedure
  • Liver dysfunction with elevation of liver enzymes and bilirubin levels to ≥ 3x ULN or INR (Internationalized Normalized Ratio) ≥2
  • Uncorrectable abnormal coagulation parameters
  • Active systemic infection requiring treatment with antibiotics
  • Clinically relevant stroke or TIA within 3 months of procedure. Patients with suspected stroke or TIA within 3 months of procedure must have documented absence of neurological infarction
  • Uncontrollable allergy or intolerance to heparin, aspirin, clopidogrel, ionic and nonionic contrast media, or any other potentially required anticoagulants or antiplatelet therapy drugs
  • History of heparin induced thrombocytopenia
  • Patient is pregnant or planning to become pregnant during the study period
  • Participation in another clinical study of an investigational drug or device that has not met its primary endpoint-

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02156609


Locations
Colombia
Instituto del Corazon
Bucaramanga, Colombia
Netherlands
Erasmus Medical Center
Rotterdam, Netherlands, 3000 CA
Paraguay
Sanatorio Italiano
Asuncion, Paraguay
Poland
Samodzielny Publiczny Szpital (The Prof. Leszka Gieca Upper-Silesian Medical Centre)
Katowice, Poland, 40-635
University Hospital in Krakow (John Paul II)
Krakow, Poland, 31-202
The Cardinal Stefan Wyszynski Institute of Cardiology
Warszawa, Poland, 04-628
Slaskie Centrum Chorob Serca w Zabrzu (Silesian Center for Heart Disease)
Zabrze, Poland, 41-800
Sponsors and Collaborators
Thoratec Corporation
St. Jude Medical
Investigators
Principal Investigator: Dariusz Dudek, MD Jagiellonian University

Responsible Party: Thoratec Corporation
ClinicalTrials.gov Identifier: NCT02156609     History of Changes
Other Study ID Numbers: PHPCEMark
First Posted: June 5, 2014    Key Record Dates
Last Update Posted: April 11, 2016
Last Verified: April 2016

Keywords provided by St. Jude Medical ( Thoratec Corporation ):
HeartMate PHP
HeartMate PHP CE Mark
Percutaneous coronary intervention
PCI
Percutaneous ventricular assist
Thoratec Corporation