NCT00596726

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: Abiomed Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Cardiac Surgery

Interventions

Type	Name	Description
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

Timeline

• Start date: 2006-08-01
• Primary completion: 2010-04-01
• Completion: 2010-05-01
• First posted: 2008-01-17
• Last updated: 2010-05-27

Locations

7 sites across 1 country: United States