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Mechanical Circulatory Support Device

Single arm all comers supported with Impella 5.5 for Cardiogenic Shock

N/A
Waitlist Available
Led By Ahmad Zeeshan, MD
Research Sponsored by Abiomed Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up one year
Awards & highlights

Summary

A multi-center, prospective \& retrospective, observational single-arm study of the clinical outcomes up to one year collected from electronic health records of patients which have undergone standard of care implantation of Impella 5.5, regardless of clinical situation or indication. All patients will be enrolled via an IRB-approved Waiver of Informed Consent and HIPAA Authorization. All patients who were supported retrospectively (prior to site IRB approval) with Impella 5.5 at the investigative site will be entered into the SURPASS registry and specified as the retrospective cohort.

Eligible Conditions
  • Cardiogenic Shock
  • Heart Failure

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~one year
This trial's timeline: 3 weeks for screening, Varies for treatment, and one year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Survival Outcome

Trial Design

1Treatment groups
Experimental Treatment
Group I: Single arm all comers supported with Impella 5.5Experimental Treatment1 Intervention

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Who is running the clinical trial?

Abiomed Inc.Lead Sponsor
41 Previous Clinical Trials
32,002 Total Patients Enrolled
Ahmad Zeeshan, MDPrincipal InvestigatorAdvent Health Orlando
Masaki Funamoto, MDPrincipal InvestigatorMethodist San Antonio Hospital
~60 spots leftby Dec 2024
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