Trial to Evaluate Safety And Effectiveness of Mechanical Circulatory Support in Patients With Advancing Heart Failure
Condition(s) studied
Investigational drug(s) / intervention(s)
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
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.
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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.
View NCT06526195 on ClinicalTrials.gov ↗ ← All trials in the USA