European Clinical Evaluation of the Carmat Total Artificial Heart (ADVANCEHF)
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|ClinicalTrials.gov Identifier: NCT02962973|
Recruitment Status : Suspended (Occurrence of a quality issue affecting some of its prostheses)
First Posted : November 15, 2016
Last Update Posted : January 6, 2022
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.
|Condition or disease||Intervention/treatment||Phase|
|Advanced Heart Failure||Device: CARMAT TAH Procedure: Surgical intervention||Not Applicable|
Center selection is based on the following: experience with VAD/TAH implantation and record of good results in this patient population (% of survival), the infrastructure required to perform the clinical investigation (especially the surgical and cardiology teams); site resources and experience to manage the clinical study and the patient population; the adherence to the standards of Good Clinical Practice. A specific focus during the site selection is done on dedicated VAD - nurse team to ensure that:
- Sites are experienced in the selection of patients whom require a mechanical circulatory support. Social and psychological conditions of the patient and family must be considered to ensure patient and family commitment in the care pathway,
- Close supervision of patients on the use of the device (when changing batteries) by experienced hospital professionals is guarantee;
- Extensive hospital training program and regular support for patients and family - relatives are ensured.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Clinical Evaluation of the Carmat Total Artificial Heart for Patients With Advanced Heart Failure|
|Actual Study Start Date :||September 2016|
|Estimated Primary Completion Date :||December 2022|
|Estimated Study Completion Date :||December 2023|
Experimental: Carmat TAH
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
- Proportion of participants with survival at 180 days [ Time Frame: 180 days ]Success is defined as survival at 180 days after Carmat TAH implantation or transplanted if before 180 days.
- Overall survival [ Time Frame: 180 days ]Patient follow-up
- General health status change (1) [ Time Frame: 180 days ]Measured with the EuroQol EQ-5D questionnaire, a descriptive system of health-related quality of life states consisting of five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which can take one of five responses (EQ-5D-5L). The responses record five levels of severity (1:no problems; 2:slight problems; 3:moderate problems 4:severe problems; 5:extreme problems) within a particular EQ-5D dimension.
- General health status change (2) [ Time Frame: 180 days ]Change as measured by the SF-36 questionnaire, consisting of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability.
- Functional status change [ Time Frame: 180 days ]New York Heart Association (NYHA) functional classification (regression scale I, II, III, IV)
- Change in functional status measured by the Six Minutes Walk Test [ Time Frame: 180 days ]The 6-min walk test is a submaximal exercise test that entails measurement of distance walked over a span of 6 minutes. The 6-minute walk distance provides a measure for integrated global response of multiple cardiopulmonary and musculoskeletal systems involved in exercise.
- Adverse events [ Time Frame: 180 days ]Adverse Event Rates will be captured per the INTERMACS definitions
- hospital readmission rate [ Time Frame: 180 days ]
Rate of unplanned readmissions to the hospital
- Frequency and incidence of all adverse events
- Frequency and incidence of pre-defined anticipated adverse events
- Frequency, incidence and type of device malfunction
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02962973
|Institute for Clinical and Experimental Medicine|
|Prague, Czechia, 140 21|
|Service de Chirurgie Cardiaque - Institut Cœur Poumon|
|Lille, France, 59037|
|CHU Pontchaillou Centre Cardio-Pneumologie|
|Rennes, France, 35033|
|"National Research Cardiac Surgery Center"|
|Astana, Kazakhstan, 010000|
|Study Director:||Piet Jansen, MD, PhD||Carmat SA|