Skip to main content
OpenTrials
Completed

NCT Number: NCT02156609

HeartMate PHP™ CE Mark Clinical Investigation Plan

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

High Risk Percutaneous Coronary Intervention

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Instituto del Corazon, Bucaramanga, Colombia

Loading trial locations.

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • At least 18 years of age.
  • Patient presents with a non-emergent need for complex PCI with:
  • an ejection fraction of ≤35% requiring hemodynamic support during the procedure, AND
  • 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-

Treatment and study plan

Percutaneous ventricular support with the HeartMate PHP

Device

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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Abbott Medical Devices

Industry

Registry information

Acronym: HM PHP CE Mark

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jun 5, 2014
Registry last updated
Jun 24, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.