NCT04117295

Brief Summary

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

Trial Health

53
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial recruitment is currently suspended
Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
8mo left

Started Jul 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

4 active sites

Status
suspended

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress88%
Jul 2021Jan 2027

First Submitted

Initial submission to the registry

October 3, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 7, 2019

Completed
1.8 years until next milestone

Study Start

First participant enrolled

July 12, 2021

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2026

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2027

Expected
Last Updated

January 28, 2025

Status Verified

January 1, 2025

Enrollment Period

4.7 years

First QC Date

October 3, 2019

Last Update Submit

January 25, 2025

Conditions

End-stage Heart Failure

Keywords

Heart Replacement TherapyTotal Artificial HeartBiventricular Heart Failure

Outcome Measures

Primary Outcomes (1)

  • Survival

    Proportion of patients surviving on the Carmat TAH

    180 days

Secondary Outcomes (7)

  • Survival without Permanent Neurologic Deficit

    180 days

  • Post transplant survival

    30 days

  • Change in functional status

    180 days

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

    180 days

  • Generic health status change

    180 days

  • +2 more secondary outcomes

Study Arms (1)

Treatment

EXPERIMENTAL

Subjects implanted with the Carmat TAH

Device: Carmat Total Artificial Heart

Interventions

Carmat Total Artificial HeartDEVICE

Heart replacement therapy

Treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Must be 18 years of age or older at the time of informed consent
  • Anatomic compatibility confirmed using 3D imaging (CT-scan).
  • Inotrope dependent (with documented attempt to wean) or cardiac Index (CI) \< 2.2 L/min/m2 if inotropes are contra-indicated (heart failure due to restrictive or constrictive physiology).
  • On Optimal Medical Management as judged by the investigator based on current Heart Failure practice guidelines (ESC/AHA).
  • Eligible for biventricular Mechanical Circulatory Support according to ISHLT guidelines for mechanical circulatory support:
  • Biventricular failure with at least two of the following hemodynamic/ echocardiographic measurements implying right heart failure: RVEF ≤30%; RVSWI ≤0.25mmHg\*L/m2; TAPSE ≤14mm; RV-to-LV end-diastolic diameter ratio \>0.72; CVP \>15 mmHg; CVP-to-PCWP ratio \>0.63; Tricuspid insufficiency grade 4; PAPi\<2
  • Treatment-refractory recurrent and sustained ventricular tachycardia or ventricular fibrillation in the presence of untreatable arrhythmogenic pathologic substrate.
  • Heart failure due to restrictive or constrictive physiology (e.g., hypertrophic cardiomyopathy, cardiac amyloidosis / senile or other infiltrative heart disease).
  • Patient has signed the informed consent, has full understanding of procedures, and is committed to following study requirements.
  • Eligible for cardiac transplantation

You may not qualify if:

  • Known intolerance to anticoagulant or antiplatelet therapies or known Heparin Induced Thrombocytopenia.
  • Presence of any non-temporary mechanical circulatory support
  • Presence of temporary mechanical circulatory support such as Impella (all types) or IABP with a duration greater than 21 days
  • Presence of ECMO with a duration greater than 7 days
  • Patient is intubated and unconscious, or intubated and not awake
  • Coagulopathy defined by platelets \< 100k/µl or INR ≥ 1.5 not due to anticoagulant therapy.
  • Cerebrovascular accident \< 3 months or symptomatic 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 any of the following criteria:
  • Total bilirubin \> 2.5 mg/dl or cirrhosis evidenced by ultrasound, CT-scan and positive biopsy
  • eGFR \< 30ml/min/1.73m2 or the need for chronic renal replacement therapy
  • History of severe Chronic Obstructive Pulmonary Disease with FEV1/FVC \<0.7, or FEV1\<50% predicted or severe restrictive lung disease.
  • Recent blood stream infection (\<7 days).
  • Documented amyloid light-chain (AL amyloidosis).
  • Hemodynamically significant peripheral vascular disease with documented ankle- brachial pressure index (ABPI) \<0.3.
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

University of Louisville Jewish Hospital

Louisville, Kentucky, 40202, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Baylor University Medical Center

Dallas, Texas, 75226, United States

Location

VCU Medical Center

Richmond, Virginia, 23298, United States

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 3, 2019

First Posted

October 7, 2019

Study Start

July 12, 2021

Primary Completion

April 1, 2026

Study Completion (Estimated)

January 1, 2027

Last Updated

January 28, 2025

Record last verified: 2025-01

Locations

US(4)