MedTrace Logo

RECOVER I Impella RECOVER LP/LD 5.0 Support System Safety and Feasibility Study

NCT00596726 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2010-05-27

No results posted yet for this study

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.

Conditions

  • Cardiac Surgery

Interventions

DEVICE

IMPELLA LP/LD 5.0

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

Sponsors & Collaborators

  • Abiomed Inc.

    lead INDUSTRY

Principal Investigators

  • Bartley Griffith, M.D. · University of Maryland

  • Mark Anderson · Robert Wood Johnson Foundation

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-08-31
Primary Completion
2010-04-30
Completion
2010-05-31

Countries

  • United States

Study Locations

More Related Trials

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 NCT00596726 on ClinicalTrials.gov