European Clinical Evaluation of the Carmat Total Artificial Heart

NCT02962973 | Suspended DMC

• 2 other identifiers: CAR2016-01CIV-FR-16-09-016865
• Study Type: interventional
• Target: 20
• Locations: 2 countries
• Sites: 2

Brief 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

Keywords

Advanced heart failure; Total artificial heart

Outcome Measures

Primary Outcomes (1)

• Proportion of participants with survival at 180 days

  Success is defined as survival at 180 days after Carmat TAH implantation or transplanted if before 180 days.

  180 days

Secondary Outcomes (7)

• Overall survival

  180 days

• General health status change (1)

  180 days

• General health status change (2)

  180 days

• Functional status change

  180 days

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

  180 days

Study Arms (1)

Carmat TAH

EXPERIMENTAL

The surgical intervention takes place through a midsternotomy utilizing cardiopulmonary bypass. The device is then connected via a percutaneous driveline to an external controller and batteries and takes over the circulation.

Device: CARMAT TAH; Procedure: Surgical intervention

Interventions

CARMAT TAH DEVICE

Carmat TAH

Surgical intervention PROCEDURE

Carmat TAH

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient age: 18 to 75 years
• Inotrope dependent 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 to 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 ≤ 0.25 mmHg\*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
• 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)
• Anatomic compatibility confirmed using 3D imaging (CT-scan)

You may not qualify if:

• Body Mass Index (BMI) \< 15 or \> 47
• Existence of any ongoing non-temporary mechanical circulatory support
• Existence of any temporary mechanical circulatory support other than IABP and Impella
• History of cardiac or other organ transplant
• Patients who have required cardiopulmonary resuscitation for \> 30 minutes within 14 days prior to implant
• Known intolerance to anticoagulant or antiplatelet therapies
• Coagulopathy defined by platelets \< 100k/μl or INR ≥ 1.5 not due to anticoagulant therapy
• Cerebro-vascular accident \< 3 months or symptomatic or a known \> 80% carotid stenosis
• Known abdominal or thoracic aortic aneurysm \> 5 cm
• End-organ dysfunction as per investigator judgment and following but not limited criteria:
• Total bilirubin \> 100 μmol/L (5,8 mg/dl) or cirrhosis evidenced by ultrasound, CT-scan or positive biopsy
• GFR \< 30ml/min/1.73m2
• History of severe Chronic Obstructive Pulmonary Disease or severe restrictive lung disease
• Recent blood stream infection (\<7 days)
• Documented amyloid light-chain (AL amyloidosis)

Sponsors & Collaborators

• Carmat SAS: lead

Study Sites (2)

"National Research Cardiac Surgery Center"

Astana, 010000, Kazakhstan

Location

UMC Utrecht

Utrecht, 3508GA, Netherlands

Location

Related Publications (2)

• Netuka I, Pya Y, Bekbossynova M, Ivak P, Konarik M, Gustafsson F, Smadja DM, Jansen P, Latremouille C. Initial bridge to transplant experience with a bioprosthetic autoregulated artificial heart. J Heart Lung Transplant. 2020 Dec;39(12):1491-1493. doi: 10.1016/j.healun.2020.07.004. Epub 2020 Jul 14. No abstract available.

  PMID: 32758387 DERIVED

• Bizouarn P, Roussel JC, Trochu JN, Perles JC, Latremouille C. Effects of pre-load variations on hemodynamic parameters with a pulsatile autoregulated artificial heart during the early post-operative period. J Heart Lung Transplant. 2018 Jan;37(1):161-163. doi: 10.1016/j.healun.2017.06.018. Epub 2017 Jul 8. No abstract available.

  PMID: 28736110 DERIVED

MeSH Terms

Interventions

Surgical Procedures, Operative

Study Officials

• Piet Jansen, MD, PhD

  Carmat SAS

  STUDY DIRECTOR

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: November 8, 2016
• First Posted: November 15, 2016
• Study Start: September 1, 2016
• Primary Completion: December 1, 2025
• Study Completion (Estimated): July 1, 2026
• Last Updated: February 14, 2025

Record last verified: 2025-02

Locations

KA (1); NL (1)