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NCT06965504NARecruiting

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

Abiomed Inc.

Start Date

10/2/2026

Completion Date

6/1/2029

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.

Detailed Description

This is a prospective, single arm, multi-center, post-market, on-label study. For patients presenting with cardiogenic shock in the setting of cardiomyopathy, including peripartum cardiomyopathy, or myocarditis (also known as decompensated heart failure complicated with cardiogenic shock, commonly referred to as heart failure-related cardiogenic shock, HF-CS, including both acute-on-chronic and de novo presentations) as a result of isolated left ventricular failure that is not responsive to optimal medical management and conventional treatment measures (including volume loading and use of pressors and inotropes, with or without IABP), an intentional device-supported strategy with Impella 5.5™ for optimization of guideline-directed medical therapy (GDMT) combined with best practices improves outcomes over standard of care.

Eligibility Criteria

Age Range: 18 years to 80 years

Inclusion Criteria: 1. Age ≥ 18 and \< 80 years 2. Subject or subject's legally authorized representative (LAR) has signed the Informed Consent Form 3. LVEF ≤ 40% 4. Subject is presenting with decompensated heart failure and meets at least two (2) of the following cardiogenic shock criteria: 1. 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) 2. Hypoperfusion (physical sign(s) of organ hypoperfusion or serum lactate \>2 mmol/L) 3. Cardiac index (CI) \< 2.2 L/min/m2 determined to be secondary to cardiac dysfunction, in the absence of hypovolemia 4. Required support with an intra-aortic balloon pump (IABP) or Impella CP™ 5. Subject has inadequate heart failure GDMT based on the most recent outpatient prescription prior to index admission, defined as: 1. On 2 or less of the 4-Pillar HF Drug Classes (BB, MRA, SGLT2i, and RASi) 2. If on BB and RASi, at least one of the two medications is \< 50% of the maximal target dose Exclusion Criteria: 1. Underlying unmodifiable conditions that limit initiation of GDMT prior to enrollment, including but not limited to: 1. 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. 2. Known bilateral renal artery stenosis 3. Type 1 diabetes 4. 2o or 3o AV block, unless pacemaker is in place 5. Angioedema, hereditary or idiopathic 6. Pregnancy, known or confirmed by a pregnancy test if of childbearing potential 2. ST-segment elevation or acute coronary syndrome (ACS) prior to enrollment 3. Septic shock, shock from non-cardiac origins, or mixed shock 4. SCAI Stage E cardiogenic shock per study definition (Appendix C) prior to enrollment 5. In cardiac arrest prior to enrollment 6. 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: 1. IABP use \>24 hours if placed at the enrolling site or \>48 hours if transferred on IABP 2. Impella CP™ use \>24 hours if placed at the enrolling site or \>48 hours if transferred on Impella CP™ 3. Experienced complication(s) from IABP including clinically significant vascular injury, limb ischemia, end organ damage, or bleeding requiring transfusion(s) per Investigator's discretion 4. Experienced complication(s) from Impella CP™ including clinically significant hemolysis, vascular injury, limb ischemia, end organ damage, or bleeding requiring transfusion(s) per Investigator's discretion 7. On mechanical circulatory support other than IABP or Impella CP™ (i.e. ECMO, etc) or on mechanical ventilation for non-procedural reasons prior to enrollment 8. Revascularization or cardiac surgery within 30-days prior to enrollment 9. Infiltrative/restrictive cardiomyopathy (sarcoidosis and amyloidosis), hypertrophic cardiomyopathy, constrictive pericarditis, pericardiac tamponade, or myocarditis requiring high-dose immunosuppression 10. Complex adult congenital heart disease 11. Primary severe valvular disease 12. Predominant RV dysfunction per Investigator's discretion 13. History of heart transplant or listed for heart transplant or planned for heart transplantation prior to enrollment 14. Planned to be implanted with a permanent VAD within 180-days of the index hospitalization date 15. Continuous outpatient inotropic support prior to the index hospitalization date 16. Planned to pursue palliative care or hospice, or life expectancy of less than 1 year due to non-cardiac illness at the time of index hospitalization date 17. Currently on dialysis, or has pre-existing end-stage chronic kidney disease (stage 4 and above), or has nephropathy of hereditary, infectious, or autoimmune origin 18. Pre-existing functional liver disease including liver cirrhosis, alcoholic hepatitis, metabolic dysfunction associated steatohepatitis (MASH), or genetic liver disease 19. Pre-existing pulmonary disease with oxygen dependency 20. History of stroke or intracranial hemorrhage ≤ 90 days prior to the index hospitalization date, or a history of cerebrovascular disease with significant (\> 80%) uncorrected carotid stenosis, or any permanent neurological deficit with modified Rankin Scale (mRS) \>2 21. Any contraindication that precludes placing an Impella 5.5™, including but not limited to: 1. Aortic valve stenosis/calcification with orifice area ≤ 0.6cm2 or aortic insufficiency of any grade greater than mild on pre-procedure echocardiography 2. Presence of mechanical aortic valve or heart constrictive device 3. Mural thrombus in the left ventricle 4. Severe arterial disease precluding placement of Impella 5. Presence of atrial or ventricular septal defect 6. Left ventricular rupture 7. Cardiac tamponade 8. Combined cardiorespiratory failure 22. Infection of the planned procedural access site or systemic active infection including sepsis and bacteremia 23. Intolerance to anticoagulant or antiplatelet therapies, or will refuse blood transfusions 24. Subject has other medical, social or psychological problems that, in the opinion of the Investigator, compromises the subject's ability to give written informed consent and/or to comply with study procedures 25. Participation in the active treatment or follow-up phase of another clinical study of an investigational drug or device 26. Subject belongs to a vulnerable population, such as prisoners, pregnant women, handicapped, mentally disabled persons, or economically or educationally disadvantaged persons per 21CFR56.111(a)(3) and 111(b)

Interventions

DEVICE

Impella 5.5 SmartAssist

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Conditions

Heart FailureCardiogenic ShockReduced Ejection Fraction Heart Failure

Locations

Tampa General Hospital

Tampa, Florida 33606

United States

Ascension St. Vincent

Indianapolis, Indiana 46260

United States

Abbott Northwestern

Minneapolis, Minnesota 555407

United States

Barnes Jewish

St Louis, Missouri 63110

United States

Hackensack University Medical Center

Hackensack, New Jersey 07601

United States

Rutgers-Robert Wood Johnson Medical School

New Brunswick, New Jersey 08901

United States

New York Presbyterian - Columbia

New York, New York 10032

United States

Westchester Medical Center

Valhalla, New York 10595

United States

Atrium Health- Sanger Heart and Vascular Institute

Charlotte, North Carolina 28204

United States

Duke University

Durham, North Carolina 27710

United States

Wake Forest Baptist Medical Center

Winston-Salem, North Carolina 27157

United States

University of Pennsylvania Health System

Philadelphia, Pennsylvania 19104

United States

Allegheny General Hospital

Pittsburgh, Pennsylvania 15212

United States

UPMC Presbyterian

Pittsburgh, Pennsylvania 15213

United States

Centennial Medical Center

Nashville, Tennessee 32703

United States

Medical City Heart Hospital Dallas

Dallas, Texas 75243

United States

University of Utah

Salt Lake City, Utah 84132

United States