Clinical trial NCT00596726: RECOVER I Impella RECOVER LP/LD 5.0 Support System Safety and Feasibility Study
Official title: RECOVER I: IMPELLA® RECOVER® LP/LD 5.0 Support System: A Clinical Safety & Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cardiac Surgery
Keywords: All patients presenting for high-risk cardiac surgery and who might post-operatively meet the study inclusion criteria are potential study candidates.
Lead sponsor: Abiomed Inc.
Sponsor class: INDUSTRY
First posted: 2008-01-17
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Frequency of Major Adverse Events
timeFrame: 30 day or discharge
Secondary outcomes:
measure: Other Adverse Events Doppler echocardiography assessment of aortic valve function will be performed at explant and 30days and 3 month follow-ups.
timeFrame: 3 months
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: University of Maryland
state: Maryland
city: Boston
country: United States
facility: Massach General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Brigham & Womens
state: Massachusetts
city: New Brunswick
country: United States
facility: Robert Wood Johnson
state: New Jersey
city: New York,
country: United States
facility: Columbia Presbyterian Hospital
state: New York
city: Hershey
country: United States
facility: Hershey Medical Center
state: Pennsylvania
city: Houston
country: United States
facility: Texas Heart
state: Texas
Study officials:
affiliation: University of Maryland
name: Bartley Griffith, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Robert Wood Johnson Foundation
name: Mark Anderson
role: PRINCIPAL_INVESTIGATOR
References: