Trial to Evaluate Safety And Effectiveness of Mechanical Circulatory Support in Patients With Advancing Heart Failure
NCT Number: NCT06526195
Acronym: TEAM-HF
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Heart Failure|Heart Diseases|Cardiovascular Diseases|Pulmonary Hypertension
Interventions: DEVICE: CardioMEMS HF System|DEVICE: HeartMate 3 Left Ventricular Assist System|OTHER: Guideline Medical Directed Therapy
Sponsor: Abbott Medical Devices
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 850
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-12
Completion Date: 2032-09

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.

Primary Outcome Measures: 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 Randomized population.

Primary Endpoint definitions:

* Disabling stroke: Modified Rankin Score ≥ 3
* Urgent heart transplantation: United Network for Organ Sharing (UNOS) listing status 1-3
* Enrollment into hospice: admission requiring palliative care for end of life for support.
* Temporary mechanical circulatory support: short-term univentricular or biventricular support, extracorporeal membrane oxygenation (ECMO), intra-aortic balloon pump (IABP), Impella, Percutaneous VAD, etc.
* Dependence on intravenous inotropes: infusion of inotropes for \>14 days., 2 years
Secondary Outcome Measures: 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 Randomized population., 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 Randomized 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., 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 Randomized 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., 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 Randomized 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., 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 Randomized 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., 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 Randomized 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., 2 years
Other Outcome Measures: Finkelstein-Schoenfeld Win Ratio, The Finkelstein-Schoenfeld Win Ratio will be explored at 5 years as an additional analysis with the following hierarchy:

1. Survival
2. Days alive outside of the hospital
3. Quality of Life assessed with the KCCQ (considered a tie if within 10 points)
4. Functional Capacity (Six-minute walk distance)

The Finkelstein-Schoenfeld Win Ratio will be analyzed between the HM3 Group and the Control Group within the Randomized population. Additionally, the Finkelstein-Schoenfeld Win Ratio will be descriptively analyzed between the Single Arm and both the HM3 Group and Control Group of the Randomized Arm separately., 5 years|Survival free of urgent LVAD or transplant, This additional descriptive analysis at 5-years will be performed to evaluate the proportion of patients who are alive and free of device replacement or transplant in the HM3 Group compared to the Single Arm Registry (de novo implant or transplant), 5 years