RecruitingNot applicable

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests how safe and effective the HeartMate 3 heart pump is compared with recommended heart failure medicines. It is for people with advanced heart failure who can still walk around and do not depend on medicines given through a vein to help the heart pump.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Sign a consent form before any study procedures.
  • Have a heart pumping strength (LVEF) of 30% or less and a cardiac index, a measure of blood flow, of 2.5 or less.
  • Have limited activity due to heart failure: walk 350 meters or less in 6 minutes, or have low oxygen use on an exercise test.
  • Have severe heart failure symptoms, called NYHA class IIIB or IV.
  • Have at least one hospital stay for heart failure in the past 12 months.
  • Already have, or agree to get, a CardioMEMS sensor to measure pressure in the lung artery.
  • Be willing and able to get the HeartMate 3 pump if assigned to that group.
  • For assignment to a treatment group, have the sensor for at least 90 days, an average lung artery pressure of at least 30 mmHg, and recommended medicines at the best tolerated doses for at least 30 of the last 90 days. A separate tracking group is for people with pressure below 30 mmHg who get the sensor after joining and meet the same medicine rule.

Who can't join

  • Be younger than 18, or have depended on vein-given medicines to help the heart pump in the last 30 days.
  • Have a medical reason not to use either device, unusually high implant surgery risk, current mechanical heart support, or plans for a heart pump before joining.
  • Have certain causes of heart failure, such as untreated thyroid disease, certain thick or stiff heart muscle diseases, protein buildup called amyloidosis, or disease of the sac around the heart.
  • Have complex heart defects present at birth, a past organ transplant, or a mechanical aortic heart valve that will not be replaced with a tissue valve or sewn closed during pump surgery.
  • Have an active, uncontrolled infection, or mental health, lasting thinking, or social problems likely to prevent following study or pump care instructions.
  • Be pregnant, or be able to become pregnant but unwilling to use birth control with the pump.
  • Have a lung blood clot within 30 days, repeated lung or deep vein blood clots, or specified signs of severe kidney, liver, lung, blood vessel, or blood-clotting problems.
  • Have another illness that could limit life to less than 24 months, join another treatment study that could affect these results, or have another factor making either study treatment unusually risky.

Simplified for readability. The official criteria below are what the study team uses.

Official 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 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.

Study sites (57)

AR

AZ

CA

DC

FL

GA

IA

IL

IN

KS

KY

MA

ME

MI

MN

MO

NC

NE

NJ

NM

NY

OH

OK

OR

PA

SC

TN

TX

UT

VA

WI