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Evaluating a heart pump for patients with advanced heart failure

Trial to Evaluate Safety And Effectiveness of Mechanical Circulatory Support in Patients With Advancing Heart Failure

Not applicable Interventional Abbott Medical Devices · NCT06526195

This study is testing if a heart pump can help people with advanced heart failure feel better compared to standard medication, while also checking if certain pressure readings can help find the right patients for this treatment.

Quick facts

PhaseNot applicable
Study typeInterventional
Enrollment850 (estimated)
Ages18 Years and up
SexAll
SponsorAbbott Medical Devices Industry-sponsored
Locations63 sites (Phoenix, Arizona and 62 other locations)
Trial IDNCT06526195 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to assess the safety and effectiveness of the HeartMate 3 Left Ventricular Assist Device (LVAD) compared to guideline-directed medical therapy in patients with advanced heart failure who are not dependent on intravenous inotropes. Approximately 850 subjects with New York Heart Association Class IIIB/IV heart failure and elevated pulmonary artery pressure will be enrolled. Participants will either have a previously implanted CardioMEMS PA Sensor or will receive one after enrollment to monitor their condition. The trial seeks to determine if elevated pulmonary artery pressure can help identify patients who would benefit most from LVAD therapy.

Who should consider this trial

Good fit: Ideal candidates are patients with advanced heart failure (NYHA Class IIIB/IV) who have had a heart failure hospitalization in the past year and elevated pulmonary artery pressure.

Not a fit: Patients who are not experiencing advanced heart failure or those who are dependent on intravenous inotropes may not benefit from this study.

Why it matters

Potential benefit: If successful, this trial could provide a new treatment option that improves survival and quality of life for patients with advanced heart failure.

How similar studies have performed: Other studies have shown success with LVAD therapy in similar populations, but this specific approach in non-inotrope dependent patients is less explored.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. Subject has provided written informed consent by signing the study Informed Consent Form (ICF) prior to any clinical investigation-related procedure
2. LVEF ≤30% and Cardiac Index ≤ 2.5 L/min/m²
3. Limited functional status as demonstrated by 6MWT ≤ 350 m due to HF related reasons OR peak VO2 ≤ 14 mL/kg/min (or \<50% of predicted peak VO2 value)
4. NYHA Class IIIB or NYHA Class IV
5. Subject has ≥ 1 Heart Failure Hospitalization in the last 12 months
6. Subject is already implanted with a CardioMEMS PA Sensor OR willing to undergo a CardioMEMS PA Sensor implant
7. Subject is willing and able to be implanted with the HM3 LVAS if randomized to HM3 Group

Randomization Criteria:

1. Subject has been implanted with a CardioMEMS PA Sensor for at least 90 days.
2. Subject is receiving guideline directed medical therapy with optimal doses (or documented medication contraindication or intolerance) of betablockers, Angiotensin-Converting-Enzyme-inhibitors or Angiotensin II Receptor Blockers or angiotensin receptor neprilysin inhibitor (if eligible), Mineralocorticoid Receptor Antagonists, Sodium-Glucose co-Transporter-2 (SGLT2) inhibitors, and diuretics for at least 30 of the last 90 days.
3. mean PAP ≥ 30 mmHg.
4. The subject will not be randomized if they have any other factor that represents inordinate risk for either continued GDMT or LVAD implant.

Single Arm Registry Criteria:

1. Subject has received a CardioMEMS PA Sensor implant following enrollment in the trial.
2. Subject is receiving guideline directed medical therapy with optimal doses (or documented medication contraindication or intolerance) of betablockers, Angiotensin-Converting-Enzyme-inhibitors or Angiotensin II Receptor Blockers or angiotensin receptor neprilysin inhibitor (if eligible), Mineralocorticoid Receptor Antagonists, Sodium-Glucose co-Transporter-2 (SGLT2) inhibitors, and diuretics for at least 30 of the last 90 days.
3. mean PAP \<30 mmHg

Exclusion Criteria:

1. Subject is \< 18 years of age at the time of informed consent.
2. Dependent on IV inotrope in the last 30 days.
3. Contra-indications to HM3 LVAS or CardioMEMS HF system.
4. Etiology of HF due to or associated with uncorrected thyroid disease, obstructive cardiomyopathy, pericardial disease, amyloidosis, or restrictive cardiomyopathy.
5. Technical obstacles to LVAD or CardioMEMS implantation which pose an inordinately high surgical risk, in the judgment of the implanter.
6. Existence of ongoing MCS.
7. Presence of mechanical aortic valve that will not be either converted to a bioprosthesis or oversewn at the time of LVAD implant.
8. History of any solid organ transplant.
9. Psychiatric disease/disorder, irreversible cognitive dysfunction or psychosocial issues that are likely to impair compliance with the study protocol and LVAS management.
10. Presence of an active, uncontrolled infection.
11. Complex congenital heart disease.
12. Currently Pregnant or capable of becoming Pregnant and Unwilling to Use Contraception with LVAD.
13. History of pulmonary embolism within 30 days prior to enrollment or history of recurrent (\>1 episode) pulmonary embolism and/or deep vein thrombosis.
14. Planned VAD or Bi-VAD support prior to enrollment.
15. Presence of any one of the following risk factors for or indications of severe end organ dysfunction or failure:

    1. An INR ≥ 2.0 not due to anticoagulation therapy
    2. An eGFR \< 30 mL/min/1.73 m2 and nonresponsive to diuretic therapy or receiving chronic dialysis.
    3. Biopsy proven liver cirrhosis.
    4. Need for chronic renal replacement therapy.
    5. History of severe chronic obstructive pulmonary disease (COPD) defined by Forced Expiratory Volume FEV1 \< 30% predicted.
    6. History of cerebrovascular disease with significant (\> 80%) uncorrected internal carotid stenosis.
    7. Significant peripheral vascular disease (PVD) accompanied by ischemic rest pain or extremity ulceration.
16. Any condition other than HF that could limit survival to less than 24 months.
17. Participation in any other clinical investigation with an active treatment arm that is likely to confound study results or affect the study outcome.

Where this trial is running

Phoenix, Arizona and 62 other locations

+13 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Heart FailureHeart DiseasesCardiovascular DiseasesPulmonary HypertensionLeft Ventricular Assist DeviceGuideline Directed Medical TherapyNon-inotrope DependentPulmonary Artery Pressure
Last reviewed 2026-06-09 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.