NCT06965504

Brief Summary

The study will evaluate the impact of a combined device-drug strategy with Impella 5.5 with best practices and optimized GDMT on heart recovery outcomes in patients with decompensated heart failure and cardiogenic shock.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P75+ for not_applicable heart-failure

Timeline
32mo left

Started Sep 2026

Typical duration for not_applicable heart-failure

Geographic Reach
1 country

15 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress3%
Sep 2026Jun 2029

First Submitted

Initial submission to the registry

April 21, 2025

Completed
20 days until next milestone

First Posted

Study publicly available on registry

May 11, 2025

Completed
1.3 years until next milestone

Study Start

First participant enrolled

September 1, 2026

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2028

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2029

Last Updated

September 10, 2026

Status Verified

September 1, 2026

Enrollment Period

2.3 years

First QC Date

April 21, 2025

Last Update Submit

September 8, 2026

Conditions

Heart FailureCardiogenic ShockReduced Ejection Fraction Heart Failure

Keywords

Impella 5.5Heart Failure Cardiogenic ShockReduced Ejection Fraction Heart FailureMechanical Circulatory SupportCardiovascular DiseaseHeart DiseaseGuideline Directed Medical Therapy

Outcome Measures

Primary Outcomes (1)

  • Composite of all-cause death, HF hospitalization, and heart replacement (heart transplantation or durable LVAD implantation)

    Timeframe: 180-days post-enrollment

Secondary Outcomes (20)

  • Composite of all-cause death and heart replacement

    90-days, 180-days, 1-year post-enrollment

  • Composite of all-cause death, HF hospitalization, and heart replacement

    90-days, 1-year post-enrollment

  • All-cause mortality

    Hospital Discharge (within 24 hours) , 90-days, 180-days, 1-year post-enrollment

  • Cardiovascular mortality

    Hospital Discharge (within 24 hours), 90-days, 180-days, 1-year post-enrollment

  • Worsening heart failure

    90-days, 180-days, 1-year post-enrollment

  • +15 more secondary outcomes

Study Arms (1)

Single arm study

OTHER

This is a single arm study.

Device: Impella 5.5 SmartAssist

Interventions

Impella 5.5 SmartAssistDEVICE

The intervention is Impella 5.5 with SmartAssist® support combined with protocolized guideline directed medical therapy (GDMT) and HF-CS best practices.

Single arm study

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥ 18 and \< 80 years
  • Subject or subject's legally authorized representative (LAR) has signed the Informed Consent Form
  • LVEF ≤ 40%
  • Subject is presenting with decompensated heart failure and meets at least two (2) of the following cardiogenic shock criteria:
  • Hypotension (sustained episode of systolic blood pressure ≤ 90 mmHg for at least 30 minutes or need for inotropic/vasoactive agents to maintain such blood pressure)
  • Hypoperfusion (physical sign(s) of organ hypoperfusion or serum lactate \>2 mmol/L)
  • Cardiac index (CI) \< 2.2 L/min/m2 determined to be secondary to cardiac dysfunction, in the absence of hypovolemia
  • Required support with an intra-aortic balloon pump (IABP) or Impella CP™
  • Subject has inadequate heart failure GDMT based on the most recent outpatient prescription prior to index admission, defined as:
  • On 2 or less of the 4-Pillar HF Drug Classes (BB, MRA, SGLT2i, and RASi)
  • If on BB and RASi, at least one of the two medications is \< 50% of the maximal target dose

You may not qualify if:

  • Underlying unmodifiable conditions that limit initiation of GDMT prior to enrollment, including but not limited to:
  • Drug allergies or hypersensitivities\* to HF GDMT medications, unless alternative can be identified
  • \*Drug allergy/hypersensitivity is an immune-mediated reaction to a medication. Adverse reactions must be a result of immune or inflammatory cell stimulations by the mеԁiсаtion.
  • Known bilateral renal artery stenosis
  • Type 1 diabetes
  • o or 3o AV block, unless pacemaker is in place
  • Angioedema, hereditary or idiopathic
  • Pregnancy, known or confirmed by a pregnancy test if of childbearing potential
  • ST-segment elevation or acute coronary syndrome (ACS) prior to enrollment
  • Septic shock, shock from non-cardiac origins, or mixed shock
  • SCAI Stage E cardiogenic shock per study definition (Appendix C) prior to enrollment
  • In cardiac arrest prior to enrollment
  • Prolonged use (or use with complication) of Intra-aortic balloon pump (IABP) or Impella CP™ prior to enrollment, meeting at least one of the following:
  • IABP use \>24 hours if placed at the enrolling site or \>48 hours if transferred on IABP
  • Impella CP™ use \>24 hours if placed at the enrolling site or \>48 hours if transferred on Impella CP™
  • +30 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

Tampa General Hospital

Tampa, Florida, 33606, United States

Location

Ascension St. Vincent

Indianapolis, Indiana, 46260, United States

Location

Abbott Northwestern

Minneapolis, Minnesota, 555407, United States

Location

Barnes Jewish

St Louis, Missouri, 63110, United States

Location

Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

Location

Rutgers-Robert Wood Johnson Medical School

New Brunswick, New Jersey, 08901, United States

Location

Atrium Health

Charlotte, North Carolina, 28204, United States

Location

Duke University

Durham, North Carolina, 27710, United States

Location

Wake Forest Baptist Medical Center

Winston-Salem, North Carolina, 27157, United States

Location

University of Pennsylvania Health System

Philadelphia, Pennsylvania, 19104, United States

Location

Allegheny General Hospital

Pittsburgh, Pennsylvania, 15212, United States

Location

UPMC Presbyterian

Pittsburgh, Pennsylvania, 15213, United States

Location

Centennial Medical Center

Nashville, Tennessee, 32703, United States

Location

Medical City Heart Hospital Dallas

Dallas, Texas, 75243, United States

Location

University of Utah

Salt Lake City, Utah, 84132, United States

Location

MeSH Terms

Conditions

Heart FailureShock, CardiogenicHeart Failure, SystolicCardiovascular DiseasesHeart Diseases

Condition Hierarchy (Ancestors)

Myocardial InfarctionMyocardial IschemiaVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosisShock

Study Officials

  • Adam DeVore, MD, MHS

    Duke University

    PRINCIPAL INVESTIGATOR

  • Gavin Hickey, MD

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR

  • Manreet Kanwar, MD

    University of Chicago

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Roberta Chapman, MD, FACC, FACP, FHFSA

CONTACT

+1 978-882-8421rchapm11@its.jnj.com

Stacie Hallaway

CONTACT

839-216-3087shallawa@its.jnj.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 21, 2025

First Posted

May 11, 2025

Study Start

September 1, 2026

Primary Completion (Estimated)

December 1, 2028

Study Completion (Estimated)

June 1, 2029

Last Updated

September 10, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share

Locations

US(15)