CompletedNot Applicable

MOMENTUM 3 IDE Clinical Study Protocol

United States1,028 participantsStarted 2014-09-02

Plain-language summary

The objective of the study is to evaluate the safety and effectiveness of the HM3 LVAS by demonstrating non-inferiority to the HMII LVAS (HMII) when used for the treatment of advanced, refractory, left ventricular heart failure.

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 heart failure (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 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

Short Term Primary End Point

Timeframe: The first 294 randomized Subjects will be followed for 6 months or to outcome (transplant, explant, or death), whichever occurs first.

Long Term Primary End Point

Timeframe: The first 366 randomized Subjects will be followed for 24 months or to outcome (transplant, explant, or death), whichever occurs first.

Trial details

NCT IDNCT02224755

SponsorAbbott Medical Devices

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2018-09-28

Results submitted2019-10-02

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