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Thoratec Corporation HeartMate PHP™ Cardiogenic Shock Trial

NCT02279979 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2023-07-21

No results posted yet for this study

Summary

The primary objective of this study is to assess reasonable safety and performance of the HeartMate PHP to provide hemodynamic support for up to 72 hours in patients with cardiogenic shock requiring stabilization.

Conditions

  • Cardiogenic Shock

Interventions

DEVICE

HeartMate PHP

The HeartMate PHP system is a catheter-based heart pump and console designed to provide hemodynamic left ventricular support for up to 3 days to stabilize patients by maintaining adequate systemic cardiac output.

Sponsors & Collaborators

  • Thoratec Corporation

    collaborator INDUSTRY

  • Abbott Medical Devices

    lead INDUSTRY

Principal Investigators

  • Pooja Chatterjee · Thoratec LLC, St. Jude Medical, Abbott

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-10-31
Primary Completion
2017-01-31
Completion
2017-01-31

Countries

  • Czechia
  • Germany
  • Hungary
  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02279979 on ClinicalTrials.gov