First in Human Study of the Icoms Flowmaker (NCT07632586) | Clinical Trial Compass
RecruitingNot Applicable
First in Human Study of the Icoms Flowmaker
Czechia, France10 participantsStarted 2023-12-19
Plain-language summary
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 own contribution, but a more satisfactory blood flow is restored by the complementary action of the Icoms® FlowMaker® This study is a first in human test to evaluate the safety and the performance of the Icoms Flowmaker. The study population consists of patients with severe heart failure who are at high risk for a conventional LVAD and at high risk for a percutaneous driveline. Ten patients will be recruited and implanted In France , Slovenia and Czech republic.
The study objectives are:
o evaluate the safety and performance of the Icoms® FlowMaker® implantable device in patients with severe heart failure resistant to optimal medical therapy.
--Primary Objective: Assess safety and performance of the device at 30 days post-implantation.
Secondary Objectives: Evaluate the patient's hemodynamic and clinical status, and the device's functionality per technical specifications.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
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:
* 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) volume \> 200 mL
* 6- Body Surface Area (BSA) ≥ 1.2 m².
* 7- LVEF ≤ 35 % and assessed Intermacs ≤ 4
* 8- Advanced heart failure patients symptomatic despite optimal medical management (OMM) based on the European Cardiology Society guidelines15 otherwise meeting standard best practice indications for implantable LVAD
AND fulfilling at least one of the following criteria approved by the International multidisciplinary expert selection committee:
• 9- Contraindication or excessively heightened risk of a conventional LVAD implant due to factors such as:
* CVP/PCWP ≤ 0.6
* anatomical or surgical factors constituting excessive
* perioperative implant risks.
* (Duly recorded in the source document during the patient Inform
* consent process)
OR
* 10- Patient with high risk of percutaneous driveline-induced morbidity such as:
* patient with recurrent infections / severe diabetes mellitus / immunodeficiency / cachexia
* psychological factors limiting percutaneous driveline
* acceptance and / or management duly recorded in the Psychological evaluation report at screening.
* 11- Temporary ineligibility to heart transplant(active or remission of cancer / highly sensitized PRA…) D…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.