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

Cardiac Surgery Clinical Trial

— RECOVER I  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00596726
• Other study ID #: G030202
• Status: Completed
• Phase: Phase 2
• First received: January 8, 2008
• Last updated: May 25, 2010
• Start date: August 2006
• Est. completion date: May 2010

Study information

• Verified date: May 2010
• Source: Abiomed Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: May 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cardiac Surgery

Intervention

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

Locations

Country	Name	City	State
United States	University of Maryland	Baltimore	Maryland
United States	Brigham & Womens	Boston	Massachusetts
United States	Massach General Hospital	Boston	Massachusetts
United States	Hershey Medical Center	Hershey	Pennsylvania
United States	Texas Heart	Houston	Texas
United States	Robert Wood Johnson	New Brunswick	New Jersey
United States	Columbia Presbyterian Hospital	New York,	New York

Sponsors (1)

Lead Sponsor	Collaborator
Abiomed Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of Major Adverse Events		30 day or discharge	Yes
Secondary	Other Adverse Events Doppler echocardiography assessment of aortic valve function will be performed at explant and 30days and 3 month follow-ups.		3 months	Yes