Ignite Creation Date:
2025-12-25 @ 1:11 AM
Ignite Modification Date:
2025-12-28 @ 1:55 PM
Study NCT ID:
NCT04475393
Status:
RECRUITING
Last Update Posted:
2025-01-28
First Post:
2020-07-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Carmat Total Artificial Heart As a Bridge to Transplant in Patients with Advanced Heart Failure
Sponsor:
Carmat SA
Organization:
Study Overview
Official Title:
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:
RECRUITING
Status Verified Date:
2025-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EFICAS
Brief 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
* 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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: