CardioMEMS HF SystemHeartMate 3 Left Ventricular Assist SystemGuideline Medical Directed Therapy
CardioMEMS HF System: The CardioMEMS™ HF System is comprised of a lead-less and battery-less pressure sensor which remotely transmits pulmonary artery pressure measurements.
HeartMate 3 Left Ventricular Assist System: The HeartMate 3 LVAS is a mechanical circulatory support pump with Full MagLev Technology that assumes some or all of the workload of the left ventricle. The HeartMate 3 LVAS is used in advanced heart failure patients needing short or long-term mechanical circulatory support.
Guideline Medical Directed Therapy: Optimal doses of medical therapy per established heart failure guidelines which includes the following stable combination of Beta Blockers, ACE-inhibitors or ARB or ARNi, MRA and SGLT2 inhibitors.
Study summary
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.
Primary outcome measure(s)
Survival at 2 years free of disabling stroke, reoperation to replace the device, or worsening HF requiring listing for urgent heart transplantation or mechanical circulatory support, enrollment into hospice, or dependence on IV inotropes — 2 years The powered primary endpoint will be analyzed at 2 years following the Com-Nougue method and will be compared between the HM3 Group (HM3 LVAD) and the Control Group (GDMT) within the Intention-to-treat (ITT) population.
Trial sites (68)
Facility
City
Region
Status
Banner-University Medical Center Phoenix
Phoenix
Arizona
Recruiting
Baptist Health Medical Center
Little Rock
Arkansas
Recruiting
Sutter Medical Center
Sacramento
California
Recruiting
University of California at San Francisco
San Francisco
California
Recruiting
Washington Hospital Center
Washington D.C.
District of Columbia
Recruiting
Shands at the University of Florida
Gainesville
Florida
Recruiting
Cleveland Clinic Florida
Weston
Florida
Recruiting
Piedmont Heart Institute
Atlanta
Georgia
Recruiting
Piedmont Augusta Hospital
Augusta
Georgia
Recruiting
WellStar Kennestone Hospital
Marietta
Georgia
Recruiting
University of Chicago
Chicago
Illinois
Recruiting
Advocate Health & Hospitals Corporation
Oakbrook Terrace
Illinois
Recruiting
St. Vincent Hospital
Indianapolis
Indiana
Recruiting
University of Iowa Hospitals & Clinics
Iowa City
Iowa
Recruiting
Kansas University Medical Center
Kansas City
Kansas
Recruiting
University of Kentucky
Lexington
Kentucky
Recruiting
Norton Hospital
Louisville
Kentucky
Recruiting
Maine Medical Center
Portland
Maine
Recruiting
Massachusetts General Hospital
Boston
Massachusetts
Recruiting
Henry Ford Hospital
Detroit
Michigan
Recruiting
Spectrum Health Butterworth Hospital
Grand Rapids
Michigan
Recruiting
Minneapolis Heart Institute
Minneapolis
Minnesota
Recruiting
Mayo Clinic
Rochester
Minnesota
Recruiting
St. Luke's Hospital
Kansas City
Missouri
Recruiting
University of Nebraska Medical Center
Omaha
Nebraska
Recruiting
Hackensack University Medical Center
Hackensack
New Jersey
Recruiting
Newark Beth Israel Medical Center
Newark
New Jersey
Recruiting
New Mexico Heart Institute
Albuquerque
New Mexico
Recruiting
North Shore University Hospital
Manhasset
New York
Recruiting
New York-Presbyterian/Columbia University Medical Center
New York
New York
Recruiting
University of Rochester Medical Center
Rochester
New York
Recruiting
Montefiore Medical Center - Moses Campus
The Bronx
New York
Recruiting
University of North Carolina at Chapel Hill
Chapel Hill
North Carolina
Recruiting
Carolinas Medical Center
Charlotte
North Carolina
Recruiting
Christ Hospital
Cincinnati
Ohio
Recruiting
The Cleveland Clinic Foundation
Cleveland
Ohio
Recruiting
Integris Baptist Medical Center
Oklahoma City
Oklahoma
Recruiting
Oklahoma Heart Institute at Utica
Tulsa
Oklahoma
Recruiting
Saint Francis Hospital
Tulsa
Oklahoma
Recruiting
Oregon Health & Science University
Portland
Oregon
Recruiting
+ 28 more sites — see the full list on the official registry below.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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