CompletedNot Applicable

HeartMate 3™ LIS Study

Czechia, Germany13 participantsStarted 2015-05

Plain-language summary

The purpose of this study is to evaluate a less invasive implantation technique of the HeartMate 3 Left Ventricular Assist System (HM 3 LVAS) in 10 patients.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Patient or legal representative has signed Informed Consent Form (ICF)
✓. Age ≥ 18 years
✓. BSA ≥ 1.2 m2
✓. NYHA IIIB or IV, or ACC/AHA Stage D
✓. LVEF ≤ 25%
✓. CI ≤ 2.2 L/min/m2, while not on inotropes (if Patient is treated with inotropes at baseline, this does not apply)
✓. Patients 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
✕. Lactating mothers
✕. Presence of mechanical aortic cardiac valve
✕. History of any organ transplant
✕. Platelet count \< 100,000 x 103/L (\< 100,000/ml)

What they're measuring

Number of survival participants

Timeframe: 30 days

Trial details

NCT IDNCT02475460

SponsorAbbott Medical Devices

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2016-01

View on ClinicalTrials.gov More Heart Failure trials