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European Clinical Evaluation of the Carmat Total Artificial Heart

NCT02962973 · Status: SUSPENDED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2025-02-14

No results posted yet for this study

Summary

The objective of this clinical investigation is to evaluate the safety and performance of the Carmat Total Artificial Heart (TAH) in subjects with advanced heart failure requiring biventricular support.

Each subject receiving the Carmat TAH will be evaluated at 6 months (180 days) for primary and secondary endpoints with further follow-up assessments up to 2 years.

The results of the study will be used to support a CE mark application.

Conditions

  • Advanced Heart Failure

Interventions

DEVICE

CARMAT TAH

PROCEDURE

Surgical intervention

Sponsors & Collaborators

  • Carmat SA

    lead INDUSTRY

Principal Investigators

  • Piet Jansen, MD, PhD · Carmat SA

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-09-30
Primary Completion
2025-12-31
Completion
2026-07-31

Countries

  • Kazakhstan
  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02962973 on ClinicalTrials.gov