Trial to Evaluate Safety And Effectiveness of Mechanical Circulatory Support in Patients With Advancing Heart Failure
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAbbott Medical Devices
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Subject has provided written informed consent by signing the study Informed Consent Form (ICF) prior to any clinical investigation-related procedure
LVEF ≤30% and Cardiac Index ≤ 2.5 L/min/m²
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)
NYHA Class IIIB or NYHA Class IV
Disqualifiers
Subject is < 18 years of age at the time of informed consent.
Dependent on IV inotrope in the last 30 days.
Contra-indications to HM3 LVAS or CardioMEMS HF system.
Etiology of HF due to or associated with uncorrected thyroid disease, obstructive cardiomyopathy, pericardial disease, amyloidosis, or restrictive cardiomyopathy.
Trial design
Design model
Parallel
Treatments tested in this trial
CardioMEMS HF System
DeviceThe 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
DeviceThe 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
Other interventionOptimal 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.
Treatment groups
850 Participants
are divided into 3 treatment groupsGroup A: Randomized Arm - HM3 GroupExperimental treatment 3 interventions
Group B: Randomized Arm - Control GroupExperimental treatment 2 interventions
Group C: Single Arm RegistryExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
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 yearsSecondary outcomes
1
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 year2
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 years3
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.
Time frame
2 years4
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 yearsOther outcomes
1
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 Intention-to-treat (ITT) 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.
Time frame
5 years2
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)
Time frame
5 yearsSponsors and contacts
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Source ClinicalTrials.gov