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.
Patients with heart failure (HF) suffer from a high degree of morbidity and mortality. Left ventricular assist device (LVAD) therapy has become the standard of care for the treatment of advanced HF patients who are deemed to be dependent on continuous intravenous inotropes, extending life expectancy, enhancing overall quality of life, and improving functional capacity. However, use of LVADs in ambulatory, non-inotrope dependent advanced HF population is limited. Elevated mean pulmonary artery pressure (PAP) secondary to left ventricular failure has emerged as a potential predictor of increased mortality risk for patients refractory to maximally tolerated guideline directed medical therapy (GDMT). In these patients, left ventricular failure with elevated mean PAP may represent objective criteria to identify advanced HF patients requiring heart replacement therapies such as LVAD. The TEAM-HF IDE trial will enroll approximately 850 subjects with New York Heart Association (NYHA) Class IIIB/IV HF who had a prior heart failure hospitalization and an elevated mean PAP secondary to left ventricular failure. Elevated mean PAP will be identified using an implanted PAP monitoring sensor, the CardioMEMS PA Sensor. All subjects enrolled can have a previously implanted CardioMEMS PA Sensor or, if not, will be implanted with the CardioMEMS PA Sensor after enrollment. The overall objectives of TEAM-HF trial are two-fold: 1) To determine whether PAP can objectively identify patients most at risk for worsening HF and therefore most likely to benefit from earlier intervention with LVAD therapy and 2) To determine the benefit of LVAD therapy in non-inotrope advanced HF patients with elevated mean PAP refractory to GDMT. The trial will include approximately 75 global sites and consists of a Randomized Arm and a Single Arm Registry. The TEAM-HF Randomized Arm is a prospective, randomized, open-label study of the HeartMate 3 (HM3) left ventricular assist system (LVAS) versus continued GDMT in non-inotrope dependent HF patients. The objectives of the Randomized Arm are 1) To establish an objective disease-state criteria to trigger referral for a HM3 LVAS and 2) Demonstrate improvement in survival when non-inotrope dependent advanced HF patients are treated with the HM3 LVAS compared to being managed on medical therapy alone. The TEAM-HF Single Arm Registry is a prospective, single-arm, open-label study of non-inotrope dependent HF patients who do not meet a mean PAP threshold after GDMT optimization. The objective of the Single Arm Registry is to characterize the progression of patients with non-inotrope dependent HF without elevated PAP.
The CardioMEMS™ HF System is comprised of a lead-less and battery-less pressure sensor which remotely transmits pulmonary artery pressure measurements.
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.
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.
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
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.
Time frame: 2 years
Rate of Safety Outcomes at 1-year
The powered secondary endpoint of Rate of Safety Outcomes at 1-year will be evaluated within the Intention-to-treat (ITT) population against a pre-specified performance goal. Components consist of the following: 1. Heart failure hospitalization 2. Major Adverse Event (MAE) including: * Stroke * Non-surgical bleeding (\>14 days post implant) requiring hospitalization * Renal failure requiring hospitalization * Driveline infection requiring hospitalization
Time frame: 1 year
Survival at 2 years
The powered secondary endpoint of survival at 2-years will be compared between the HM3 Group and the Control Group within the Intention-to-treat (ITT) population.
Time frame: 2 years
Quality of life score assessed with the Kansas City Cardiomyopathy Questionnaire
The secondary endpoint of Quality-of-life score at 2-years will be compared between the HM3 Group and the Control Group within the Intention-to-treat (ITT) population. Additionally, the secondary endpoint of Quality of life at 2-years will be descriptively compared between the Single Arm Registry and both the HM3 Group and Control Group of the Randomized Arm separately. The KCCQ scores are represented on a 0-to-100-point scale, where lower scores represent more severe symptoms and/or limitations and scores of 100 indicate no symptoms, no limitations, and excellent quality of life. Improvement of KCCQ by at least 10 points is considered clinically significant.
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Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
850
Banner-University Medical Center Phoenix
Phoenix, Arizona, United States
RECRUITINGBaptist Health Medical Center
Little Rock, Arkansas, United States
RECRUITINGSutter Medical Center
Sacramento, California, United States
RECRUITINGUniversity of California at San Francisco
San Francisco, California, United States
RECRUITINGWashington Hospital Center
Washington D.C., District of Columbia, United States
RECRUITINGShands at the University of Florida
Gainesville, Florida, United States
RECRUITINGCleveland Clinic Florida
Weston, Florida, United States
RECRUITINGPiedmont Heart Institute
Atlanta, Georgia, United States
RECRUITINGPiedmont Augusta Hospital
Augusta, Georgia, United States
RECRUITINGWellStar Kennestone Hospital
Marietta, Georgia, United States
RECRUITING...and 53 more locations
Time frame: 2 years
Six-minute walk distance
The secondary endpoint of six-minute walk distance at 2-years will be compared between the HM3 Group and the Control Group within the Intention-to-treat (ITT) population. Additionally, the secondary endpoint of six-minute walk distance at 2-years will be descriptively compared between the Single Arm Registry and both the HM3 Group and Control Group of the Randomized Arm separately.
Time frame: 2 years
Hospitalizations for HF and/or Urgent HF Visit
The secondary endpoint of Hospitalizations for HF and/or Urgent HF Visit at 2-years will be compared between the HM3 Group and the Control Group within the Intention-to-treat (ITT) population. Additionally, the secondary endpoint of Hospitalizations for HF and/or Urgent HF Visit at 2-years will be descriptively compared between the Single Arm Registry and both the HM3 Group and Control Group of the Randomized Arm separately.
Time frame: 2 years
Days alive and outside of the hospital
The secondary endpoint of days alive and outside of the hospital at 2-years will be compared between the HM3 Group and the Control Group within the Intention-to-treat (ITT) population. Additionally, the secondary endpoint of days alive and outside of the hospital at 2-years will be descriptively compared between the Single Arm Registry and both the HM3 Group and Control Group of the Randomized Arm separately.
Time frame: 2 years
All-cause hospitalizations
The secondary endpoint of all-cause hospitalizations at 2-years will be compared between the HM3 Group and the Control Group within the Intention-to-treat (ITT) population. Additionally, the secondary endpoint of all-cause hospitalizations at 2-years will be descriptively compared between the Single Arm Registry and both the HM3 Group and Control Group of the Randomized Arm separately.
Time frame: 2 years
All adverse events (including all strokes) regardless of severity
The secondary endpoint of all adverse events (including all strokes) regardless of severity at 2-years will be compared between the HM3 Group and the Control Group within the Intention-to-treat (ITT) population. Additionally, the secondary endpoint of all adverse events (including all strokes) regardless of severity at 2-years will be descriptively compared between the Single Arm Registry and both the HM3 Group and Control Group of the Randomized Arm separately.
Time frame: 2 years