NCT04475393

Carmat Total Artificial Heart as a Bridge to Transplant in Patients With Advanced Heart Failure

Multicentric Prospective Cohort Study in Patients With Irreversible Biventricular Heart Failure to Assess the Efficacy and Safety of Carmat TAH, Its Clinical Utility and Cost, as a Bridge to Transplantation

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 52 (estimated)
• Sponsor: Carmat SAS · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The objective of this clinical investigation is to evaluate the efficacy and the safety of the Carmat Total Artificial Heart for the treatment of refractory advanced heart failure in transplant eligible patients.

Detailed description

A selection committee (composed of two independent experts in the field of cardiovascular surgery/cardiology and of PIs) assess the subject eligibility based on clinical and anatomic criteria. Clinically eligible patients will be distributed into two cohorts depending on their anatomic compatibility with the device: * cohort 1: patients that are anatomically compatible will receive the Carmat TAH ; * cohort 2: patients that are not anatomically compatible will receive standard therapy The efficacy and safety of the Carmat TAH will be assessed in cohort 1 and compared to a level of efficacy defined by the published data on the commercially available TAH; and adjusted for INTERMACS patient profile. The clinical utility and the costs of Carmat TAH will be assessed by comparing the cohort of subject receiving the Carmat TAH to the cohort of patients treated by standard therapy

Conditions

• Advanced Heart Failure

Interventions

Type	Name	Description
DEVICE	Carmat Total Artificial Heart	Heart Replacement Therapy

Timeline

• Start date: 2022-12-12
• Primary completion: 2025-10-24
• Completion: 2027-04-01
• First posted: 2020-07-17
• Last updated: 2026-01-28

Locations

10 sites across 1 country: France