NCT04117295

Carmat TAH Early Feasibility Study

Carmat Total Artificial Heart Early Feasibility Study

• Status: Suspended
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Carmat SAS · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Feasibility study of the Carmat TAH as a treatment for transplant-eligible patients in severe, end-stage heart failure.

Detailed description

This is a prospective, multi-center, staged feasibility study designed to assess the initial evidence of safety and performance of the Carmat TAH in the treatment of severe, end-stage heart failure. This study will include up to 7 centers in the US. The study population will include up to 10 transplant-eligible patients enrolled and implanted with the Carmat TAH. Data collection will be recorded prior to implantation of the device and for six months following implant, then long term at 9, 12, 18 and 24 months while the patient remains on the device. Adverse events, as defined by INTERMACS, while on device support will be collected throughout the study until study closure and will be adjudicated by an independent Clinical Event Committee. Progress reports of the clinical outcomes will be reviewed by the DSMB after implantation of each patient and every three months thereafter while any patient is supported with the device. A progress report will be sent to FDA for review after three subjects have been implanted and followed for 60 days. The primary objective of the study is survival on an original Carmat device at 180 days post-implant or survival to cardiac transplantation if occurring before 180 days post-implant.

Conditions

• End-stage Heart Failure

Interventions

Type	Name	Description
DEVICE	Carmat Total Artificial Heart	Heart replacement therapy

Timeline

• Start date: 2021-07-12
• Primary completion: 2026-04-01
• Completion: 2027-01-01
• First posted: 2019-10-07
• Last updated: 2025-01-28

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated device study