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Completed

NCT Number: NCT00596726

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

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.

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Key information

Conditions

Cardiac Surgery

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Maryland, Baltimore, Maryland, United States

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About this study

To demonstrate 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. Postcardiotomy patients, weaned from a cardiopulmonary bypass system (CPB) in need for hemodynamic support due to ineffective standard medical therapy will be considered for enrollment. An attempt shall be made to reverse the hemodynamic situation with medications (e.g. inotropes, vasopressors). The IMPELLA RECOVER LP/LD 5.0 will be implanted by the surgeon when no improvement in hemodynamics is observed.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • Renal dysfunction
  • Hepatic dysfunction
  • Right Ventricular failure defined.
  • LV or RV Thrombus
  • Other exclusions per protocol

Treatment and study plan

IMPELLA LP/LD 5.0

Device

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

Primary outcomes

  1. Frequency of Major Adverse Events

    Time frame: 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.

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

Abiomed Inc.

Industry

Registry information

Official study title

RECOVER I: IMPELLA® RECOVER® LP/LD 5.0 Support System: A Clinical Safety & Feasibility Study

Acronym: RECOVER I

Important dates

Study start
2006
Primary completion
2010
Study completion
2010
First posted
Jan 17, 2008
Registry last updated
May 27, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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