Advanced Heart FailureFAIRNCT07632586
First in Human Study of the Icoms Flowmaker
A study testing Cardiac assist device implantation during surgical intervention in people with Advanced Heart Failure, run by FineHeart at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Advanced Heart Failure
- What is being tested?
- Cardiac assist device implantation during surgical intervention
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 19 Dec 2023to Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to 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.
Show all 23Show fewer
- 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…) 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
Who cannot join
- 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.
Show all 38Show fewer
- 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 abnormalities identified by CT scan of brain-thorax and abdomino-pelvic region.
- 17- Uncorrected thrombocytopenia or generalized coagulopathy (e.g., platelet count < 100,000 / INR > 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 defect
- 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 subjects, persons deprived of liberty, protected adults, or those unable to consent
- 37- Subjects who have participated in a clinical trial within 12 months
- 38- Patient implanted with an Implantable Cardioverter Defibrillator (ICD) other than Medtronic and Boston.
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
Armand A ADJE, Clinical Project Manager contact
Stephane S Garrigue, PhD, MD contact
2 sites in 2 countries
Czechia1 site, 1 recruiting
- Recruiting
Hospitalier IKEM
Prague
Ivan Netuka, MD-PhD Cardiac Surgery, Ivne@ikem.cz
Ivan Netuka, MD-PhD, Cardiac Surgery
About this study
Official title: 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.
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:
Read more
- 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.
Read the detailed description
The role of mechanical circulatory support (MCS) in the current landscape of heart failure (HF) therapies can only be appreciated by knowing the potential number of candidates for advanced HF treatment. HF prevalence is 2.6% in the over 300 million US population. Approximately half of all patients with HF have reduced, versus preserved ejection fraction (3.5 million). Only 10-15% of those belong to the New York Heart Association (NYHA) class IIIB-IV.
These data suggest that there are as many as 500,000 patients in whom either LVAD or cardiac transplantation could be indicated following current national guidelines.. However, taking into account important limitations based on age, comorbidities, social and financial constraints, the actual number might be less, but nevertheless 125,000 to 250,000 patients remain as potential candidates for this advanced therapy. The INTERMACS Class 4-7 . population presents an incidence of at least 100,000 patients per year in the USA, Canada and Europe. The main indications for the use of implantable LVADs in patients with end-stage HF are either as a bridge to candidacy (BTC), or as long-term option for those who do not qualify for cardiac transplantation, previously referred to as destination therapy (DT). Only 7.000 to 9.000 MCS devices are implanted worldwide every year, which represents a significant lack of treatment in such sick and mostly not elderly patients.
Consequently, there is a huge discrepancy between the need for MCS treatment (up to 250,000 patients) and the real proportion of patients implanted, due to known, much feared current LVAD-induced complications.
Yet, the greatest increase in LVAD volume has not been in those considered candidates for bridge to heart transplantation (BTT) but for DT, which requires technical improvements to expand MCS devices implants in less severe patients.5-6. The overall survival with LVAD therapy is ≈ 80% at 1 year, and 60% at 5 years, with survival for DT indication lower than other indications at all time points, because of higher incidence of comorbidities and LVAD complications . Presently, the use of the terms BTT or DT to define the indication for LVAD implantation is being replaced by whether the support is intended for temporary or chronic use10.
The Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) database now includes 25,000 patients:
- 97% benefit from a non-physiological continuous-flow VAD
- The average age at implant is 57 years and 80% are male.
- Overall, 1- and 2-year survival is 80% and 70%, respectively.
- Most implanted patients are INTERMACS Class 1-3 (80-85%).
- Patients with ambulatory HF still account for only 16% of durable device implants to date, due to the fear for LVAD-induced complications.
- Today, nearly 41% are implanted with an intent for long-term DT.
- With the HeartMate 3, neither survival rate, nor infection rate did improve compared to the Intermacs registry cohort only thrombosis and disabling stroke were significantly reduced at 2-year follow-up.
All these precious epidemiological data highlight the crucial need for a new type of MCS device, being more physiological and pulsatile, without a percutaneous driveline (i.e. "fully implantable"). It needs to be easier to implant and/or replace, with less invasive surgery without CPB and thus, finally able to address the most important population of severe HF patients.
- Conditions
- Advanced Heart Failure
- Being tested
- Cardiac assist device implantation during surgical intervention
- Keywords
- Severe heart failure, wireless implantable cardiac device, Icoms Flowmaker
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac assist device implantation during surgical interventionDevice
Wireless cardiac assist device implanted without using CPB
| Study group | Role | What they receive |
|---|---|---|
| Subject with avance heart failure, intermacs> or = 4 | Experimental | The study population consists of 1 arm of patients with severe heart failure who are at high risk for a conventional LVAD and at high risk for a percutaneous driveline Receives: Device: Cardiac assist device implantation during surgical intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Device Safety
Survival free from stroke with MRS ≥ 3
Measured: at 1 month post-implant
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.
Measured: 1 month post implant
Device Safety
Frequency of Device-related infection
Measured: 1 month Post - implant
Secondary outcomes (10)
Improvement of the patient clinical condition
1 NYHA functional status improvement
Measured: At 1 Month, 2 month , 3 month and 6 month post -implant
Improvement of patient clinical condition
Quality of Life Change (EQ-5DL).
Measured: 1month, 2 month, 3 month and 6 month post-implant
Improvement of the patient clinical condition
Withdrawal of intravenous inotropic drugs.
Measured: 1 month, 2 month, 3 month and 6 month post-implant
Improvement of the patient clinical Condition
Blood chemistry (LDH, Free Hemoglobin, Factor of Von Willebrand).
Measured: 1 month, 2 month, 3 month and 6 month post-implant
Improvement of the patient clinical condition
Improvement in 6-minute hall walk test
Measured: 1month, 2 month, 3 month and 6 month Post-implant
Device Safety
- Incidence of adverse events and unanticipated adverse device effects
Measured: 1 month, 2 month, 3 month and 6 month post-implant
Device proper functioning
Hemodynamic improvement (assessed by CO, aortic VTI, LAP, inotropic drugs weaning).
Measured: 1month, 2 month, 3 month and 6 month post-implant
Device Proper Functioning
Assessment of the external coil of the Transdermal Energy Transfer (TET) System.
Measured: 1month, 2 month, 3 month and 6 month Post-implant
Device proper functioning
- Proper functioning of the implanted battery (frequency of impnated battery failure).
Measured: 1 month, 2 month, 3 month and 6 month Post-implant
Device usability
Patient's ability to manage device alarms and the external controller, based on the device usability tests results and device deficiencies
Measured: 1 month, 2 month , 3 month and 6 month post-implant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2026
- Study start19 Dec 2023
- Primary completionDec 2027 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This study is a non-randomized, prospective, single-arm study . A total of 10 subjects are planned to be enrolled. The Icoms® FlowMaker® will be implanted in these subjects during a surgical procedure. Subjects will be followed for up to 24 months. Implantation of the first two subjects will be followed by a pause in enrollment until the primary endpoint is analyzed at one month and the DSMB has issued its recommendation . Each subject must give his/her written consent to participate to the study and must sign the study informed consent form before any study procedure can be started. The subjects will be enrolled if they meet the clinical and anatomic criteria .A screening form, duly completed by investigators with the subject clinical data related to inclusion and exclusion criteria, will be sent to the sponsor's medical expert (Selection Committee) for validation of the clinical eligibility.
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- FineHeart
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07632586
- Sponsor's protocol ID
- FAIR
- Acronym
- FAIR
- Status last verified
- Jun 2026
- First submitted
- 27 May 2026
- Last updated
- 8 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The plan is underground consolidation
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT07632586
- Acronym / sponsor ID
- FAIR / FAIR
- Conditions
- Advanced Heart Failure
- Keywords
- Severe heart failure, wireless implantable cardiac device, Icoms Flowmaker
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- FineHeartIndustry (pharma, biotech, devices)
- Study start
- 19 Dec 2023 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 8 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Detailed description
The role of mechanical circulatory support (MCS) in the current landscape of heart failure (HF) therapies can only be appreciated by knowing the potential number of candidates for advanced HF treatment. HF prevalence is 2.6% in the over 300 million US population. Approximately half of all patients with HF have reduced, versus preserved ejection fraction (3.5 million). Only 10-15% of those belong to the New York Heart Association (NYHA) class IIIB-IV.
These data suggest that there are as many as 500,000 patients in whom either LVAD or cardiac transplantation could be indicated following current national guidelines.. However, taking into account important limitations based on age, comorbidities, social and financial constraints, the actual number might be less, but nevertheless 125,000 to 250,000 patients remain as potential candidates for this advanced therapy. The INTERMACS Class 4-7 . population presents an incidence of at least 100,000 patients per year in the USA, Canada and Europe. The main indications for the use of implantable LVADs in patients with end-stage HF are either as a bridge to candidacy (BTC), or as long-term option for those who do not qualify for cardiac transplantation, previously referred to as destination therapy (DT). Only 7.000 to 9.000 MCS devices are implanted worldwide every year, which represents a significant lack of treatment in such sick and mostly not elderly patients.
Consequently, there is a huge discrepancy between the need for MCS treatment (up to 250,000 patients) and the real proportion of patients implanted, due to known, much feared current LVAD-induced complications.
Yet, the greatest increase in LVAD volume has not been in those considered candidates for bridge to heart transplantation (BTT) but for DT, which requires technical improvements to expand MCS devices implants in less severe patients.5-6. The overall survival with LVAD therapy is ≈ 80% at 1 year, and 60% at 5 years, with survival for DT indication lower than other indications at all time points, because of higher incidence of comorbidities and LVAD complications . Presently, the use of the terms BTT or DT to define the indication for LVAD implantation is being replaced by whether the support is intended for temporary or chronic use10.
The Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) database now includes 25,000 patients:
- 97% benefit from a non-physiological continuous-flow VAD
- The average age at implant is 57 years and 80% are male.
- Overall, 1- and 2-year survival is 80% and 70%, respectively.
- Most implanted patients are INTERMACS Class 1-3 (80-85%).
- Patients with ambulatory HF still account for only 16% of durable device implants to date, due to the fear for LVAD-induced complications.
- Today, nearly 41% are implanted with an intent for long-term DT.
- With the HeartMate 3, neither survival rate, nor infection rate did improve compared to the Intermacs registry cohort only thrombosis and disabling stroke were significantly reduced at 2-year follow-up.
All these precious epidemiological data highlight the crucial need for a new type of MCS device, being more physiological and pulsatile, without a percutaneous driveline (i.e. "fully implantable"). It needs to be easier to implant and/or replace, with less invasive surgery without CPB and thus, finally able to address the most important population of severe HF patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This study is a non-randomized, prospective, single-arm study . A total of 10 subjects are planned to be enrolled. The Icoms® FlowMaker® will be implanted in these subjects during a surgical procedure. Subjects will be followed for up to 24 months. Implantation of the first two subjects will be followed by a pause in enrollment until the primary endpoint is analyzed at one month and the DSMB has issued its recommendation . Each subject must give his/her written consent to participate to the study and must sign the study informed consent form before any study procedure can be started. The subjects will be enrolled if they meet the clinical and anatomic criteria .A screening form, duly completed by investigators with the subject clinical data related to inclusion and exclusion criteria, will be sent to the sponsor's medical expert (Selection Committee) for validation of the clinical eligibility.
| Arm | Type | Receives |
|---|---|---|
| Subject with avance heart failure, intermacs> or = 4 | Experimental | Device: Cardiac assist device implantation during surgical interventionThe study population consists of 1 arm of patients with severe heart failure who are at high risk for a conventional LVAD and at high risk for a percutaneous driveline |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- 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
Key exclusion criteria (38 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cardiac assist device implantation during surgical interventionWireless cardiac assist device implanted without using CPB | Device | Subject with avance heart failure, intermacs> or = 4 |
Primary outcome
Device Safety
Time frame: at 1 month post-implant
Survival free from stroke with MRS ≥ 3
Device Safety and Performance
Time frame: 1 month post implant
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.
Device Safety
Time frame: 1 month Post - implant
Frequency of Device-related infection
10 secondary outcomes
Improvement of the patient clinical condition
Time frame: At 1 Month, 2 month , 3 month and 6 month post -implant
Improvement of patient clinical condition
Time frame: 1month, 2 month, 3 month and 6 month post-implant
Improvement of the patient clinical condition
Time frame: 1 month, 2 month, 3 month and 6 month post-implant
Improvement of the patient clinical Condition
Time frame: 1 month, 2 month, 3 month and 6 month post-implant
Improvement of the patient clinical condition
Time frame: 1month, 2 month, 3 month and 6 month Post-implant
Device Safety
Time frame: 1 month, 2 month, 3 month and 6 month post-implant
Device proper functioning
Time frame: 1month, 2 month, 3 month and 6 month post-implant
Device Proper Functioning
Time frame: 1month, 2 month, 3 month and 6 month Post-implant
Device proper functioning
Time frame: 1 month, 2 month, 3 month and 6 month Post-implant
Device usability
Time frame: 1 month, 2 month , 3 month and 6 month post-implant
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2026.
- Individual participant dataSharing planned: Undecided. The plan is underground consolidation
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Armand A ADJE, Clinical Project Manager contact
Stephane S Garrigue, PhD, MD contact
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cardiac assist device implantation during surgical intervention in people with Advanced Heart Failure, run by FineHeart at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 23 inclusion and 38 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Czechia, France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Armand A ADJE, Clinical Project Manager (+33640380538 ext. +33784895534, armand.adje@fine-heart.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Device Safety (time frame: at 1 month post-implant). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2026.