First in Human Study of the Icoms Flowmaker
ConditionAdvanced Heart Failure
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorFineHeart
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 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
1-Body Mass Index (BMI) > 40.
2- TAPSE ≤10 mm
3- Pulmonary VTI ≤ 6cm
4- Patients not eligible to transplant due to surgical risks
Trial design
Design model
Single group
Treatments tested in this trial
Cardiac assist device implantation during surgical intervention
DeviceWireless cardiac assist device implanted without using CPB
Treatment groups
10 Participants
are divided into 1 treatment groupGroup A: Subject with avance heart failure, intermacs> or = 4Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Device Safety
Survival free from stroke with MRS ≥ 3
Time frame
at 1 month post-implant2
Device Safety and Performance
Frequency of device-related reoperations Nota Bene: In case of device replacement or heart transplantation if the patient becomes eligible to transplant during the study, the time of induction of anesthesia must be considered as the success of the bridge to transplant.
Time frame
1 month post implant3
Device Safety
Frequency of Device-related infection
Time frame
1 month Post - implantSecondary outcomes
1
Improvement of the patient clinical condition
1 NYHA functional status improvement
Time frame
At 1 Month, 2 month , 3 month and 6 month post -implant2
Improvement of patient clinical condition
Quality of Life Change (EQ-5DL).
Time frame
1month, 2 month, 3 month and 6 month post-implant3
Improvement of the patient clinical condition
Withdrawal of intravenous inotropic drugs.
Time frame
1 month, 2 month, 3 month and 6 month post-implant4
Improvement of the patient clinical Condition
Blood chemistry (LDH, Free Hemoglobin, Factor of Von Willebrand).
Time frame
1 month, 2 month, 3 month and 6 month post-implant Source ClinicalTrials.gov