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
Qualifiers
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
Treatments tested in this trial
- CardioMEMS HF System
- HeartMate 3 Left Ventricular Assist System
- Guideline Medical Directed Therapy
Treatment groups
850 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov