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New treatment option for Advanced Heart Failure
Official title First in Human Study of the Icoms Flowmaker
ClinicalTrials.gov ID: NCT07632586
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- 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
You likely can't join if
- 1-Body Mass Index (BMI) \> 40.
- 2- TAPSE ≤10 mm
- 3- Pulmonary VTI ≤ 6cm
- 4- Patients not eligible to transplant due to surgical risks
- 5- Existence of any ongoing mechanical circulatory support (MCS) other than an intra-aortic balloon pump (IABP)
- 6- History of left thoracotomy.
See the full eligibility criteria
Who can join
- 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...
- 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…) Duly recorded in the source document during the patient Inform consent process.
- 12- Patient's affiliation to health care insurance, if local requirement
- 13- 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
What rules you out
- 1-Body Mass Index (BMI) \> 40.
- 2- TAPSE ≤10 mm
- 3- Pulmonary VTI ≤ 6cm
- 4- Patients not eligible to transplant due to surgical risks
- 5- Existence of any ongoing mechanical circulatory support (MCS) other than an intra-aortic balloon pump (IABP)
- 6- History of left thoracotomy.
- 7- History of confirmed untreated abdominal or thoracic aortic aneurysm \> 5 cm.
- 8- Cardiothoracic surgery within 30 days of implant.
- 9- Acute myocardial infarction within 14 days of implant.
- 10- On ventilator support for \> 72 hours within the four days immediately prior to implant.
- 11- Pulmonary embolus within three weeks of implant.
- 12- Presence of current atrial or ventricular thrombus, confirmed by MRI, CT-SCAN or Trans-Esophageal Echocardiography.
- 13- Symptomatic cerebrovascular disease, stroke within 180 days of screening or \> 80% stenosis of carotid, vertebral or cranial vessels.
- 14- Moderate to severe aortic regurgitation, defined as \> 50% regurgitant fraction.
- 15- Moderate - Severe aortic stenosis, defined as an aortic valve area (AVA) ≤ 1.5 cm2.
- 16- 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...
- 17- Uncorrected thrombocytopenia or generalized coagulopathy (e.g., platelet count \ 2.0 in the absence of anticoagulation therapy).
- 18- Hepatic insufficiency: a total bilirubin \> 3 mg/dL within 72 hours before implant, or biopsy proven liver cirrhosis or portal hypertension.
- 19- Pulmonary vascular resistance (PVR) demonstrated to be unresponsive to pharmacological manipulation and the PVR \> 6 Wood units.
- 20- Patients with a mechanical heart valve.
- 21- Etiology of heart failure due to, or associated with, uncorrected thyroid disease, obstructive cardiomyopathy, pericardial disease, amyloidosis, active myocarditis, or restrictive cardiomyopathy, ventricular septal...
- 22- History of severe Chronic Obstructive Pulmonary Disease (COPD) or severe restrictive lung disease. GOLD (Global Initiative for Chronic Obstructive Lung Disease) score \< 3.
- 23- Participation in any other study involving investigational drugs, devices, or biologics.
- 24- Severe illness, other than heart disease, which would limit survival to a maximum of 1 year.
- 25- Peripheral vascular disease with rest pain or ischemic ulcers of the extremities.
- 26- Pregnancy.
- 27- Patient unwilling or unable to comply with study requirements.
- 28- Patients unable or unwilling to sign the written informed consent.
- 29- Technical obstacles, which pose an inordinately high surgical risk, in the judgment of the investigator.
- 30- 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.
- 31- Specific liver enzymes [AST (SGOT) and ALT (SGPT)] 3 times upper limit of normal within 72 hours before implant.
- 32- Patient living alone (without an accompanying person).
- 33- Rapid AF, unless nodo-hissian junction ablation is considered.
- 34- Mid-septal end-systolic LV diameter ≤ 25mm
- 35- Sequential Organ Failure Assessment Score (SOFA score \> 8)
- 36- Minor people, persons deprived of liberty, protected adults, or those unable to consent
- 37- people who have participated in a clinical trial within 12 months
- 38- Patient implanted with an Implantable Cardioverter Defibrillator (ICD) other than Medtronic and Boston.
The study team makes the final eligibility decision.
Where it's taking place
- Prague, Czechia
- Paris, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Prague, Czechia; Paris, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.