Thoratec Corporation HeartMate PHP™ Cardiogenic Shock Trial

Abbott Medical Devices6 sites in 4 countries9 target enrollmentOctober 2014

ConditionsCardiogenic Shock

Overview

Phase: N/A
Intervention: Not specified
Conditions: Cardiogenic Shock
Sponsor: Abbott Medical Devices
Enrollment: 9
Locations: 6
Primary Endpoint: Clinical stabilization defined as improvement of Cardiac Index to > 2.2 L/min/m2
Status: Terminated
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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.

Detailed Description

The HeartMate PHP is a catheter-based axial flow pump designed to provide partial left ventricular circulatory support. This prospective, nonrandomized, controlled, single-arm, multi-center, open-label trial will evaluate the safety and performance of the device in patients with cardiogenic shock.

Registry

clinicaltrials.gov

Start Date

October 2014

End Date

January 2017

Last Updated

2 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Abbott Medical Devices

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Patient is indicated for left ventricular support according to current medical guidelines ("current medical guidelines" applies only to patients enrolled in Germany)
•Patient has a cardiac index of \< 2.2 L/min/m2 and is being treated with at least one moderate dose inotrope or at least one moderate dose of vasopressor (e.g., milrinone ≥0.3 mcg/kg/min, dopamine \> 5 mcg/kg/min, dobutamine \> 5 mcg/kg/min) AND:
•PCWP \> 18 mmHg, AND
•Systolic blood pressure \< 100 mmHg, AND
•Decreased organ perfusion as evidenced by urine output of 50 mL/hr OR increased creatinine of 0.3 mg/dl from baseline obtained within 2 weeks, OR cool extremities
•Written, signed, and dated informed consent

Exclusion Criteria

•Patient is \>85 years of age
•Right ventricular failure requiring mechanical circulatory support
•ST elevation myocardial infarction (STEMI) within 30 days of procedure
•Cardiac arrest within 7 days of procedure requiring CPR
•Current treatment with mechanical circulatory device such as IABP, ECMO, centrifugal pump, etc.
•Documented acute myocarditis
•Active major cardiac rhythm disturbances (e.g., ventricular tachycardia, ventricular fibrillation).
•Hypertrophic disease or any left ventricular outflow tract obstruction
•Active sepsis defined as bacteremia, fever ≥ 101.5 degrees F
•Mural thrombus in the left ventricle