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

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.

Study Overview

• Status: Completed
• Conditions: High Risk Percutaneous Coronary Intervention
• Intervention / Treatment: Device: Percutaneous ventricular support with the HeartMate PHP

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
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Colombia
  • Bucaramanga, Colombia
    • Instituto del Corazon
• Netherlands
  • Rotterdam, Netherlands, 3000 CA
    • Erasmus Medical Center
• Paraguay
  • Asuncion, Paraguay
    • Sanatorio Italiano
• Poland
  • Katowice, Poland, 40-635
    • Samodzielny Publiczny Szpital (The Prof. Leszka Gieca Upper-Silesian Medical Centre)
  • Krakow, Poland, 31-202
    • University Hospital in Krakow (John Paul II)
  • Warszawa, Poland, 04-628
    • The Cardinal Stefan Wyszynski Institute of Cardiology
  • Zabrze, Poland, 41-800
    • Slaskie Centrum Chorob Serca w Zabrzu (Silesian Center for Heart Disease)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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-

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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,

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary Endpoint	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	Post procedure or at hospital discharge (whichever is longer), 30 days post procedure
Composite of Major Adverse Events (MAE)	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	Post procedure or at hospital discharge (whichever is longer), 30 days post procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Secondary Endpoint	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)	Post procedure or at hospital discharge (whichever is longer), 30 days post procedure
Major Adverse Event Composites	Individual components of the major adverse event composites	Post procedure or at hospital discharge (whichever is longer), 30 days post procedure

Collaborators and Investigators

• Sponsor: Abbott Medical Devices
• Investigators: Principal Investigator: Dariusz Dudek, MD, Jagiellonian University

Study record dates

Study Major Dates

• Study Start: June 1, 2014
• Primary Completion (Actual): November 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: May 29, 2014
• First Submitted That Met QC Criteria: June 4, 2014
• First Posted (Estimate): June 5, 2014

Study Record Updates

• Last Update Posted (Actual): June 24, 2022
• Last Update Submitted That Met QC Criteria: June 23, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: PCI; Percutaneous coronary intervention; Thoratec Corporation; HeartMate PHP; HeartMate PHP CE Mark; Percutaneous ventricular assist
• Other Study ID Numbers: PHPCEMark