First in Human Study of the Icoms Flowmaker

NCT07632586 | Recruiting DMC

• 1 other identifier: FAIR
• Study Type: interventional
• Target: 10
• Locations: 2 countries
• Sites: 2

Brief 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.

Conditions

Advanced Heart Failure

Keywords

Severe heart failure; wireless implantable cardiac device; Icoms Flowmaker

Outcome Measures

Primary Outcomes (3)

• Device Safety

  Survival free from stroke with MRS ≥ 3

  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.

  1 month post implant

• Device Safety

  Frequency of Device-related infection

  1 month Post - implant

Secondary Outcomes (10)

• Improvement of the patient clinical condition

  At 1 Month, 2 month , 3 month and 6 month post -implant

• Improvement of patient clinical condition

  1month, 2 month, 3 month and 6 month post-implant

• Improvement of the patient clinical condition

  1 month, 2 month, 3 month and 6 month post-implant

• Improvement of the patient clinical Condition

  1 month, 2 month, 3 month and 6 month post-implant

• Improvement of the patient clinical condition

  1month, 2 month, 3 month and 6 month Post-implant

Study Arms (1)

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

Device: Cardiac assist device implantation during surgical intervention

Interventions

Cardiac assist device implantation during surgical intervention DEVICE

Wireless cardiac assist device implanted without using CPB

Subject with avance heart failure, intermacs> or = 4

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• FineHeart: lead

Study Sites (2)

Hospitalier IKEM

Prague, Czechia

RECRUITING

Hôpital la pitié salpètrière

Paris, 75013, France

ACTIVE NOT RECRUITING

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Central Study Contacts

Armand A ADJE, Clinical Project Manager

CONTACT

+33640380538; armand.adje@fine-heart.com

Stephane S Garrigue, PhD, MD

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 27, 2026
• First Posted: June 8, 2026
• Study Start: December 19, 2023
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2029
• Last Updated: June 8, 2026

Record last verified: 2026-06

Locations

CZ (1); FR (1)