CompletedNot Applicable

MOMENTUM 3 Continued Access Protocol

United States1,685 participantsStarted 2016-08

Plain-language summary

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.

Who can participate

Age range18 Years – 100 Years

SexALL

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Inclusion criteria

✓. Subject or legal representative has signed Informed Consent Form (ICF)
✓. Age ≥ 18 years
✓. BSA ≥ 1.2 m2
✓. NYHA Class III with dyspnea upon mild physical activity or NYHA Class IV
✓. LVEF ≤ 25%
✓. a) Inotrope dependent OR b) CI \< 2.2 L/min/m2, while not on inotropes and subjects must also meet one of the following:
✓. Females of child bearing age must agree to use adequate contraception

Exclusion criteria

✕. Etiology of HF due to or associated with uncorrected thyroid disease, obstructive cardiomyopathy, pericardial disease, amyloidosis, or restrictive cardiomyopathy
✕. Technical obstacles which pose an inordinately high surgical risk, in the judgment of the investigator
✕. Existence of ongoing mechanical circulatory support (MCS) other than IABP
✕. Positive pregnancy test if of childbearing potential
✕. Presence of mechanical aortic cardiac valve that will not be either converted to a bioprosthesis or oversewn at the time of LVAD implant
✕. History of any organ transplant
✕. Platelet count \< 100,000 x 103/L (\< 100,000/ml)
✕. Psychiatric disease/disorder, irreversible cognitive dysfunction or psychosocial issues that are likely to impair compliance with the study protocol and LVAS management

What they're measuring

Event-Free Survival

Timeframe: Subjects will be followed for 24 months or to outcome (transplant, explant, or death), whichever occurs first.

Trial details

NCT IDNCT02892955

SponsorAbbott Medical Devices

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2020-12

Results submitted2022-01-04

View on ClinicalTrials.gov More Advanced Refractory Left Ventricular Heart Failure trials