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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from hospital admission until hospital discharge, average 5 days
Awards & highlights
Study Summary
The population enrolled in this study are all subjects who received an Impella in which a bicarbonate-based purge solution was used.
Eligible Conditions
- Cardiogenic Shock
- Percutaneous Coronary Intervention
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from hospital admission until hospital discharge, average 5 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from hospital admission until hospital discharge, average 5 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Primary Endpoint Left Sided Impella
Primary Endpoint Right Sided Impella
Trial Design
2Treatment groups
Experimental Treatment
Group I: Right sided deviceExperimental Treatment1 Intervention
All patients implanted with a right sided support Impella device -this includes the Impella RP
Group II: Left sided deviceExperimental Treatment1 Intervention
All patients implanted with a left sided support Impella device - this includes but is not limited to Impella 2.5, Impella CP, Impella 5.0, Impella 5.5.
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Who is running the clinical trial?
Abiomed Inc.Lead Sponsor
41 Previous Clinical Trials
34,225 Total Patients Enrolled
Amin Medjamia, MDStudy DirectorAbiomed Inc.
1 Previous Clinical Trials
1,000 Total Patients Enrolled
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