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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Cardiac Surgery

Intervention / Treatment
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* Device: IMPELLA LP/LD 5.0


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|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|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of Major Adverse Events |  | 30 day or discharge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Other Adverse Events Doppler echocardiography assessment of aortic valve function will be performed at explant and 30days and 3 month follow-ups. |  | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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All patients presenting for high-risk cardiac surgery and who might post-operatively meet the study inclusion criteria are potential study candidates.