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

Phase 2

Completed

• Conditions: Cardiac Surgery

• Registration Number: NCT00596726
• Lead Sponsor: Abiomed Inc.

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.

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.

Study Timeline

• Study Start: 2006-08
• Study First Submitted: 2008-01-08
• Study First Submitted QC: 2008-01-16
• Study First Posted: 2008-01-17
• Primary Completion: 2010-04
• Status Verified: 2010-05
• Study Completion: 2010-05
• Last Update Submitted: 2010-05-25
• Last Update Posted: 2010-05-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Frequency of Major Adverse Events	30 day or discharge

Secondary Outcome Measures

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

Trial Locations

Locations (7)

University of Maryland; 🇺🇸 Baltimore, Maryland, United States

Massach General Hospital; 🇺🇸 Boston, Massachusetts, United States

Hershey Medical Center; 🇺🇸 Hershey, Pennsylvania, United States

Brigham & Womens; 🇺🇸 Boston, Massachusetts, United States

Texas Heart; 🇺🇸 Houston, Texas, United States

Robert Wood Johnson; 🇺🇸 New Brunswick, New Jersey, United States

Columbia Presbyterian Hospital; 🇺🇸 New York,, New York, United States