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

NCT04475393 | Active Not Recruiting DMC

• 1 other identifier: CAR2019-FR
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 10

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.

Conditions

Advanced Heart Failure

Outcome Measures

Primary Outcomes (1)

• Survival free of disabling stroke and free of reoperation for device malfunction at 180 days post-implant

  Success is defined as survival free of disabling stroke (Modified Rankin score \>3) and free of device malfunction leading to a reoperation for device replacement or urgent transplantation, or electively transplanted within 180 days after Carmat TAH implantation

  180 days

Secondary Outcomes (8)

• Overall survival

  180 days - 1 year - 2 years

• General Health Status change

  180 days - 1 and 2 years

• Change in functional status measured by the Six Minutes Walk Test

  180 days - 1 and 2 years

• Change in functional status

  180 days - 1 and 2 years

• Adverse Events

  180 days - 1 and 2 years

Study Arms (2)

Carmat TAH (Cohort 1)

EXPERIMENTAL

Subjects implanted with Carmat TAH

Device: Carmat Total Artificial Heart

Standard Therapy (cohort 2)

ACTIVE COMPARATOR

Standard Therapy

Other: Standard therapy for heart failure

Interventions

Carmat Total Artificial Heart DEVICE

Heart Replacement Therapy

Carmat TAH (Cohort 1)

Standard therapy for heart failure OTHER

Other approaches in Bridge to Transplantation

Standard Therapy (cohort 2)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient 18 years or older
• Patient in the waiting list for heart transplant or temporarily contraindicated for heart transplant
• On inotropes or cardiac Index (CI) \< 2.2 L/min/m2
• On Optimal Medical Management as judged by the investigator based on current Heart Failure practice guidelines (ESC/HAS)
• Eligible to biventricular Mechanical Circulatory Support according to one of the following category:
• Biventricular failure with at least two of the following hemodynamic/ echocardiographic measurements implying right heart failure:
• RVEF ≤ 30% or FAC \< 35%
• RVSWI ≤ 0.25 mmHg\*L/m2
• TAPSE ≤ 14mm
• RV-to-LV end-diastolic diameter ratio \> 0.72
• CVP \> 15 mmHg or persistence of echographic and/or biological signs of hepatic congestion
• CVP-to-PCWP ratio \> 0.63
• PAP index \<2
• Tricuspid insufficiency grade 4
• Treatment-refractory recurrent and sustained ventricular tachycardia or ventricular fibrillation in the presence of untreatable arrhythmogenic pathologic substrate.

You may not qualify if:

• Absolute contra-indication for heart transplant
• Existence of any ongoing non-temporary mechanical circulatory support
• Existence of any ongoing peripheral mechanical circulatory support such as ECMO, Impella (all types), IABP with a support duration \> 21 days
• Patient intubated and unconscious; or intubated and not awake
• Known intolerance to anticoagulant or antiplatelet therapies or known Heparin Induced Thrombocytopenia.
• Coagulopathy defined by platelets \< 100G/l or INR ≥ 1.5 not due to anticoagulant therapy.
• Known thrombophilia (Antithrombin III, protein C or S deficiency) or any recurrent venous thromboembolic events requiring long term curative oral anticoagulation.
• Cerebrovascular accident \< 3 months or symptomatic (Rankin score \>1; Glasgow score \< 14) or a known \> 80% carotid stenosis.
• Known abdominal or thoracic aortic aneurysm \> 5 cm that has not been treated.
• Severe end-organ dysfunction as per the following criteria:
• Total bilirubin \> 45 µmol/l (2.65 mg/dl) or cirrhosis evidenced by ultrasound, IRM and positive biopsy
• GFR \< 30ml/min/1.73m2 (with no hemodialysis)
• History of severe Chronic Obstructive Pulmonary Disease or severe restrictive lung disease with FEV1/FVC \<0.7 and FEV1\<50% predicted.
• Recent active blood stream infection confirmed by a positive hemoculture within 48 hours.
• Documented amyloid light-chain (AL amyloidosis).

Sponsors & Collaborators

• Carmat SAS: lead

Study Sites (10)

Hôpital Louis Pradel

Bron, 69500, France

Location

CHU Dijon

Dijon, 21000, France

Location

Hôpital Marie Lannelongue

Le Plessis-Robinson, 92350, France

Location

Centre Hospitalier Régional Universitaire

Lille, 59000, France

Location

CHRU Montpellier

Montpellier, 34090, France

Location

Hôpital Laennec

Nantes, 44093, France

Location

Groupe Hospitalier Pitié-Salpêtrière,

Paris, 75013, France

Location

Hôpital Européen George Pompidou

Paris, 75015, France

Location

Hôpital Pontchaillou

Rennes, 35033, France

Location

Nouvel Hôpital Civil

Strasbourg, 67000, France

Location

Related Publications (2)

• Kirklin JK, Xie R, Cowger J, de By TMMH, Nakatani T, Schueler S, Taylor R, Lannon J, Mohacsi P, Gummert J, Goldstein D, Caliskan K, Hannan MM. Second annual report from the ISHLT Mechanically Assisted Circulatory Support Registry. J Heart Lung Transplant. 2018 Jun;37(6):685-691. doi: 10.1016/j.healun.2018.01.1294. Epub 2018 Jan 31.

  PMID: 29550146 BACKGROUND

• Arabia FA, Cantor RS, Koehl DA, Kasirajan V, Gregoric I, Moriguchi JD, Esmailian F, Ramzy D, Chung JS, Czer LS, Kobashigawa JA, Smith RG, Kirklin JK. Interagency registry for mechanically assisted circulatory support report on the total artificial heart. J Heart Lung Transplant. 2018 Nov;37(11):1304-1312. doi: 10.1016/j.healun.2018.04.004. Epub 2018 Apr 26.

  PMID: 29802083 BACKGROUND

MeSH Terms

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Frederic C Daoud, MD, PhD

  Carmat SAS

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2020
• First Posted: July 17, 2020
• Study Start: December 12, 2022
• Primary Completion: October 24, 2025
• Study Completion (Estimated): April 1, 2027
• Last Updated: April 28, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (10)