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

June 23, 2022 updated by: Abbott Medical Devices
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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Post procedure or at hospital discharge (whichever is longer), 30 days post procedure
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
Post procedure or at hospital discharge (whichever is longer), 30 days post procedure

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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)
Post procedure or at hospital discharge (whichever is longer), 30 days post procedure
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
Post procedure or at hospital discharge (whichever is longer), 30 days post procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Abbott Medical Devices

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Dariusz Dudek, MD, Jagiellonian University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 29, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 4, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 5, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 24, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 23, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PHPCEMark

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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