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

Abiomed

Status and phase: Completed; Phase 2

Conditions: Cardiac Surgery

Treatments: Device: IMPELLA LP/LD 5.0

Study type: Interventional

Funder types: Industry

Identifiers

NCT00596726

G030202

Details and patient eligibility

About

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.

Full 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.

Enrollment: 17 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)