RecruitingNot ApplicableNCT07632586

First in Human Study of the Icoms Flowmaker

A Prospective, Single Arm, Multicentric, First in Human Study to Evaluate the Safety and Performance at 30 Days of the FineHeart Icoms® FlowMaker® in Subjects With Advanced Heart Failure.

Sponsor

FineHeart

Enrollment

10 participants

Start Date

Dec 19, 2023

Study Type

INTERVENTIONAL

Conditions

Advanced Heart Failure

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.

Eligibility

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria23

- Age 18 and 80 years included.
- Written inform consent.
- Females of child-bearing age must agree to use adequate contraception.
- Suitable neurocognitive status.
- Distance between the aortic valve and the LV endocardial apex ≥ 95mm and the Left Ventricular (LV) volume > 200 mL
- Body Surface Area (BSA) ≥ 1.2 m².
- LVEF ≤ 35 % and assessed Intermacs ≤ 4
- 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:
- 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
- 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.
- Temporary ineligibility to heart transplant(active or remission of cancer / highly sensitized PRA…) Duly recorded in the source document during the patient Inform consent process.
- Patient's affiliation to health care insurance, if local requirement
- Patient implanted with a cardioverter defibrillator from Medtronic and Boston or patient requiring implantation of a cardiac defibrillator due to a risk of ventricular arrhythmia

Exclusion Criteria38

-Body Mass Index (BMI) > 40.
- TAPSE ≤10 mm
- Pulmonary VTI ≤ 6cm
- Patients not eligible to transplant due to surgical risks
- Existence of any ongoing mechanical circulatory support (MCS) other than an intra-aortic balloon pump (IABP)
- History of left thoracotomy.
- History of confirmed untreated abdominal or thoracic aortic aneurysm > 5 cm.
- Cardiothoracic surgery within 30 days of implant.
- Acute myocardial infarction within 14 days of implant.
- On ventilator support for > 72 hours within the four days immediately prior to implant.
- Pulmonary embolus within three weeks of implant.
- Presence of current atrial or ventricular thrombus, confirmed by MRI, CT-SCAN or Trans-Esophageal Echocardiography.
- Symptomatic cerebrovascular disease, stroke within 180 days of screening or > 80% stenosis of carotid, vertebral or cranial vessels.
- Moderate to severe aortic regurgitation, defined as > 50% regurgitant fraction.
- Moderate - Severe aortic stenosis, defined as an aortic valve area (AVA) ≤ 1.5 cm2.
- Active, uncontrolled infections, history of hyperleukocytosis with Leucocytes > 10.000/mm3, CRP 17- 10mg/l, PCT > 0,2ng/ml, positive hemocultures < 48 hours, positive urine cultures, positive sputum cultures, any abnormalities identified by CT scan of brain-thorax and abdomino-pelvic region.
- Uncorrected thrombocytopenia or generalized coagulopathy (e.g., platelet count < 100,000 / INR > 2.0 in the absence of anticoagulation therapy).
- Hepatic insufficiency: a total bilirubin > 3 mg/dL within 72 hours before implant, or biopsy proven liver cirrhosis or portal hypertension.
- Pulmonary vascular resistance (PVR) demonstrated to be unresponsive to pharmacological manipulation and the PVR > 6 Wood units.
- Patients with a mechanical heart valve.
- Etiology of heart failure due to, or associated with, uncorrected thyroid disease, obstructive cardiomyopathy, pericardial disease, amyloidosis, active myocarditis, or restrictive cardiomyopathy, ventricular septal defect
- History of severe Chronic Obstructive Pulmonary Disease (COPD) or severe restrictive lung disease. GOLD (Global Initiative for Chronic Obstructive Lung Disease) score < 3.
- Participation in any other study involving investigational drugs, devices, or biologics.
- Severe illness, other than heart disease, which would limit survival to a maximum of 1 year.
- Peripheral vascular disease with rest pain or ischemic ulcers of the extremities.
- Pregnancy.
- Patient unwilling or unable to comply with study requirements.
- Patients unable or unwilling to sign the written informed consent.
- Technical obstacles, which pose an inordinately high surgical risk, in the judgment of the investigator.
- Intolerance to anticoagulant or antiplatelet therapies or any other peri- or postoperative therapy that the investigator may administer based upon the patient's health status.
- Specific liver enzymes \[AST (SGOT) and ALT (SGPT)\] 3 times upper limit of normal within 72 hours before implant.
- Patient living alone (without an accompanying person).
- Rapid AF, unless nodo-hissian junction ablation is considered.
- Mid-septal end-systolic LV diameter ≤ 25mm
- Sequential Organ Failure Assessment Score (SOFA score > 8)
- Minor subjects, persons deprived of liberty, protected adults, or those unable to consent
- Subjects who have participated in a clinical trial within 12 months
- Patient implanted with an Implantable Cardioverter Defibrillator (ICD) other than Medtronic and Boston.