First in Human Study of the Icoms Flowmaker

Recruiting N/A Interventional Study
Advanced Heart Failure
No Placebo Group Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
18 – 80
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
10 (estimated)
Sponsor
FineHeart · Industry
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About This Trial
The Icoms® FlowMaker® is a cardiac assist system in the true sense of the word. As assisting means to help or rescue, its function is providing assistance to the heart, which will continue to have its own hemodynamic pump function. The effect of the Icoms® FlowMaker® is to add an additional quantity of blood flow on top of the native blood flow, during each systole. The heart continues to have its…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: * 1- Age 18 and 80 years included. * 2- Written inform consent. * 3- Females of child-bearing age must agree to use adequate contraception. * 4- Suitable neurocognitive status. * 5- Distance between the aortic valve and the LV endocardial apex ≥ 95mm and the Left Ventricular (LV…
Contacts

Armand A ADJE, Clinical Project Manager

+33640380538

armand.adje@fine-heart.com

CONTACT

Stephane S Garrigue, PhD, MD

CONTACT