The objective of the study is to continue to evaluate safety and clinical performance of the HM3 LVAS for the treatment of advanced, refractory, left ventricular heart failure following completion of enrollment in the the MOMENTUM 3 IDE Study.
Enrollment in the CAP cohort ended shortly after approval for the long-term indication was received from the FDA in October 2018. As a condition of approval, all patients enrolled in the CAP cohort were to complete the 2-year follow-up to fulfil a post-approval study requirement.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
1,685
Implantation of HeartMate 3 LVAD to evaluate safety and clinical performance of the HM3 LVAS for the treatment of advanced, refractory, left ventricular heart failure following completion of enrollment in the MOMENTUM 3 IDE Study.
Event-Free Survival
Survival at 24 months free of disabling stroke (Modified Rankin Score \> 3) or reoperation to replace or remove a malfunctioning device
Time frame: Subjects will be followed for 24 months or to outcome (transplant, explant, or death), whichever occurs first.
Pump Replacement
Frequency of HeartMate 3 pump replacement at 24 months.
Time frame: As they occur up to 24 months or to outcome, whichever occurs first
Six Minute Walk Test (6MWT)
Functional status as measured by the Six Minute Walk Test. The Six Minute Walk Test measures the distance a patient is able to walk during 6 minutes without running or jogging.
Time frame: Baseline, 6 months and 24 months
New York Heart Association (NYHA) Classification
Functional status as measured by NYHA classification. NYHA class categorizes patients by the severity of their heart failure symptoms. As the class increases, the degree of symptoms is more severe indicating worse functional status. Class I indicates no limitation of physical activity. Class II indicates slight limitation of physical activity. Class IIIA indicates marked limitation of physical activity where less than ordinary physical activity causes fatigue, palpitation, dyspnea, or angina pain. Class IIIB indicates marked limitation of physical activity where mild physical activity causes fatigue, palpitation, dyspnea, or angina pain. Class IV indicates inability to carry on any physical activity without discomfort.
Time frame: Baseline, 6 months and 24 months
EuroQol-5D-5L Visual Analogue Scale
Quality of life as measured by the visual analogue scale from the EuroQol-5D-5L questionnaire. The patient rates their current state of health with the visual analogue scale. The scale ranges from 0 to 100. Higher scores indicate a better quality of life.
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Baptist Health Medical Center - Little Rock
Little Rock, Arkansas, United States
Cedars Sinai Medical Center
Beverly Hills, California, United States
University of California, San Diego
La Jolla, California, United States
Sutter Memorial Hospital
Sacramento, California, United States
Sharp Memorial Hospital
San Diego, California, United States
California Pacific Medical Center
San Francisco, California, United States
Stanford University
Stanford, California, United States
University of Colorado Hospital
Aurora, Colorado, United States
Yale New Haven Hospital
New Haven, Connecticut, United States
MedStar Washington Hospital Center
Washington D.C., District of Columbia, United States
...and 59 more locations
Time frame: Baseline, 6 months and 24 months
Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score
Quality of Life as measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ). Scores range from 0 to 100. Higher scores indicate better quality of life and fewer heart failure symptoms.
Time frame: Baseline, 6 months and 24 months
Rehospitalizations
Rate of all cause rehospitalization
Time frame: From initial discharge to 2 years post-implant
Adverse Event Rates
Events-per-patient-year (EPPY) for anticipated adverse events as defined in the study protocol
Time frame: 2 years post-implant