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

Status Recruiting

Clinical Trial 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.

Clinical Trial 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 ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04475393
Study type	Interventional
Source	Carmat SA
Contact	Soumia Aoualli
Phone	+33 63 826 5953
Email	clinique@carmatsas.com
Status	Recruiting
Phase	N/A
Start date	December 12, 2022
Completion date	April 2027

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See also
Status	Clinical Trial	Phase
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Completed	`NCT01626404` - Screening for Advanced Heart Failure Treatment (SEE-HF)
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Active, not recruiting	`NCT03874312` - Ultrasound-assessed Internal Jugular Vein Distensibility in Advanced Chronic Heart Failure (US-IJVD in CHF)
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Terminated	`NCT04703855` - Hong Kong and Taiwan HM3 PMS	N/A
Suspended	`NCT04851236` - Pilot Study of Massage Therapy to Improve Self Efficacy in Patients With Left-ventricular Device	Early Phase 1
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Completed	`NCT01210573` - Prospective Observation of Exercise Parameters in Advanced Heart Failure	N/A
Recruiting	`NCT04423562` - PROgnostic Value of Exercise Capacity Measured as Peak Oxygen Uptake (pVO2) in Recipients of Left Ventricular Assist Devices

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms