No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
850 (estimated)
Sponsor
Abbott Medical Devices · Industry
Who this trial is looking for
This trial is looking for patients with advanced heart failure who are not dependent on intravenous medications. Participants will be evaluated to see if a device called HeartMate 3 can help their heart function better compared to standard medical treatments.
Are You a Good Fit for This Trial?
Must be takingHeart Failure Medications
Rules you outSevere Lung DiseaseCirrhosisComplex Congenital Heart Disease
You may be able to join if
I have given my consent to participate in this trial.
I have a left ventricular ejection fraction (LVEF) of 30% or less.
I have had at least one heart failure-related hospital visit in the last year.
I have a limited ability to walk due to heart failure.
I can have a CardioMEMS PA Sensor implanted.
I am willing to receive the HeartMate 3 device if selected.
I have been stable on heart failure medications for at least 30 of the last 90 days.
You may not be able to join if
I am under 18 years old.
I have needed intravenous medications in the last 30 days.
I have certain medical conditions that prevent me from using HeartMate 3.
I have an active, uncontrolled infection.
I am currently pregnant or can become pregnant and won't use birth control.
I have a history of serious blood clots in the last 30 days.
I have any condition that could limit my survival to less than 24 months.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
The purpose of TEAM-HF IDE clinical trial is to evaluate safety and effectiveness of the HeartMate 3 LVAS compared to guideline directed medical therapy (GDMT) in a population of ambulatory advanced heart failure patients who are not dependent on intravenous inotrope.
Trial Locations
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Status
Eligibility 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 re…
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.
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