Back to search results

Impella 5.5 for Heart Failure Cardiogenic Shock

This study is looking at how well a combined treatment works for people with severe heart failure (heart's inability to pump enough blood) and cardiogenic shock (a life-threatening condition where your heart suddenly can't pump enough blood to meet your body's needs). The treatment involves using a device called Impella 5.5 SmartAssist along with standard medical care. Researchers want to see if this approach helps improve heart recovery and reduce serious events like death, hospital stays for heart failure, or the need for a heart transplant or a special heart pump (LVAD). You might be able to join if you are between 18 and 80 years old and have a specific type of heart failure. The study is currently unclear on its recruitment status.

Study design
This is a single-arm study, meaning all participants receive the same intervention. It aims to enroll 250 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 180 days (about 6 months) after they join the study to track outcomes.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06965504

INitiation and Titration of Guideline Directed Medical TheRApy in HearT Failure Cardiogenic Shock With ImpElla 5.5 for Cardiac Recovery

Not Yet Recruiting
NAAges 18–80InterventionalTreatment
Abiomed Inc.
~250 participants
Updated 2026-09-10 on ClinicalTrials.gov
What's tested:Impella 5.5 SmartAssist

At a glance

Recruiting sites
0 of 15 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Composite of all-cause death, HF hospitalization, and heart replacement (heart transplantation or durable LVAD implantation)
Measured over Timeframe: 180-days post-enrollment

Conditions

Heart Failure
Cardiogenic Shock
Reduced Ejection Fraction Heart Failure

Explore related trials

Cardiogenic ShockHeart failure with reduced ejection fraction

NCT06965504

Where you'd take part

This study runs at 15 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Abbott Northwestern

    Minneapolis, Minnesotastudy coordinator listed

  • Allegheny General Hospital

    Pittsburgh, Pennsylvaniastudy coordinator listed

  • Ascension St. Vincent

    Indianapolis, Indianastudy coordinator listed

  • Atrium Health

    Charlotte, North Carolinastudy coordinator listed

  • Barnes Jewish

    St Louis, Missouristudy coordinator listed

  • Centennial Medical Center

    Nashville, Tennesseestudy coordinator listed

  • Duke University

    Durham, North Carolinastudy coordinator listed

  • Hackensack University Medical Center

    Hackensack, New Jerseystudy coordinator listed

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Adam DeVore, MD, MHS · PRINCIPAL_INVESTIGATOR · Duke University
  • Gavin Hickey, MD · PRINCIPAL_INVESTIGATOR · University of Pittsburgh
  • Manreet Kanwar, MD · PRINCIPAL_INVESTIGATOR · University of Chicago

Who to contact

Roberta Chapman, MD, FACC, FACP, FHFSA
[email protected]
+1 978-882-8421
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

What this trial measures

  • Composite of all-cause death, HF hospitalization, and heart replacement (heart transplantation or durable LVAD implantation)Timeframe: 180-days post-enrollment