Overseen byMasaki Funamoto, MD
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: N/A
Waitlist Available
Sponsor: Abiomed Inc.
No Placebo Group
Trial Summary
What is the purpose of this trial?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.
Eligibility Criteria
Treatment Details
1Treatment groups
Experimental Treatment
Group I: Single arm all comers supported with Impella 5.5Experimental Treatment1 Intervention
Find a clinic near you
Research locations nearbySelect from list below to view details:
Medical University of South CarolinaCharleston, SC
University of Pittsburgh Medical CenterPittsburgh, PA
Methodist San Antonio HospitalSan Antonio, TX
The Robert Wood Johnson University HospitalNew Brunswick, NJ
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Who is running the clinical trial?
Abiomed Inc.Lead Sponsor