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RECRUITING
NCT07632586
NA

First in Human Study of the Icoms Flowmaker

Sponsor: FineHeart

View on ClinicalTrials.gov

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.

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.

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

10

Start Date

2023-12-19

Completion Date

2029-12

Last Updated

2026-06-08

Healthy Volunteers

No

Interventions

DEVICE

Cardiac assist device implantation during surgical intervention

Wireless cardiac assist device implanted without using CPB

Locations (2)

Hospitalier IKEM

Prague, Czechia

Hôpital la pitié salpètrière

Paris, France