NCT00596726

Brief Summary

To demonstrate that that the device is safe and potentially efficacious for use as a left ventricular cardiac assist device for postcardiotomy patients who require hemodynamic support post weaning from cardiopulmonary bypass.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Aug 2006

Typical duration for phase_2

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2006

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

January 8, 2008

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 17, 2008

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2010

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2010

Completed
Last Updated

May 27, 2010

Status Verified

May 1, 2010

Enrollment Period

3.7 years

First QC Date

January 8, 2008

Last Update Submit

May 25, 2010

Conditions

Cardiac Surgery

Keywords

All patients presenting for high-risk cardiac surgery and who might post-operatively meet the study inclusion criteria are potential study candidates.

Outcome Measures

Primary Outcomes (1)

  • Frequency of Major Adverse Events

    30 day or discharge

Secondary Outcomes (1)

  • Other Adverse Events Doppler echocardiography assessment of aortic valve function will be performed at explant and 30days and 3 month follow-ups.

    3 months

Interventions

IMPELLA LP/LD 5.0DEVICE

IMPELLA LP/LD 5.0 Support System is intended to be used for up to seven (7) days as a left ventricular cardiac assist device for postcardiotomy patients who, despite having been weaned from cardiopulmonary bypass (CPB), require hemodynamic support

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • BSA
  • Receiving stable infusion of one high dose inotrope or two medium dose inotropes for a respective minimum time indicated.
  • C.I.
  • Elevated Filling Pressures, PCWP or PA
  • Time to enrollment within 48 hours from weaning

You may not qualify if:

  • Renal dysfunction
  • Hepatic dysfunction
  • Right Ventricular failure defined.
  • LV or RV Thrombus

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

University of Maryland

Baltimore, Maryland, 21201, United States

Location

Massach General Hospital

Boston, Massachusetts, 02114, United States

Location

Brigham & Womens

Boston, Massachusetts, 02115, United States

Location

Robert Wood Johnson

New Brunswick, New Jersey, 08903, United States

Location

Columbia Presbyterian Hospital

New York, New York, 10032, United States

Location

Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

Texas Heart

Houston, Texas, 777030, United States

Location

Study Officials

  • Bartley Griffith, M.D.

    University of Maryland

    PRINCIPAL INVESTIGATOR

  • Mark Anderson

    Robert Wood Johnson Foundation

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

January 8, 2008

First Posted

January 17, 2008

Study Start

August 1, 2006

Primary Completion

April 1, 2010

Study Completion

May 1, 2010

Last Updated

May 27, 2010

Record last verified: 2010-05

Locations

US(7)