Carmat TAH Early Feasibility Study
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|ClinicalTrials.gov Identifier: NCT04117295|
Recruitment Status : Suspended (Occurrence of a quality issue affecting some of its prostheses)
First Posted : October 7, 2019
Last Update Posted : July 20, 2022
|Condition or disease||Intervention/treatment||Phase|
|End-stage Heart Failure||Device: Carmat Total Artificial Heart||Not Applicable|
This is a prospective, multi-center, staged feasibility study designed to assess the initial evidence of safety and performance of the Carmat TAH in the treatment of severe, end-stage heart failure. This study will include up to 7 centers in the US. The study population will include up to 10 transplant-eligible patients enrolled and implanted with the Carmat TAH.
Data collection will be recorded prior to implantation of the device and for six months following implant, then long term at 9, 12, 18 and 24 months while the patient remains on the device. Adverse events, as defined by INTERMACS, while on device support will be collected throughout the study until study closure and will be adjudicated by an independent Clinical Event Committee.
Progress reports of the clinical outcomes will be reviewed by the DSMB after implantation of each patient and every three months thereafter while any patient is supported with the device. A progress report will be sent to FDA for review after three subjects have been implanted and followed for 60 days.
The primary objective of the study is survival on an original Carmat device at 180 days post-implant or survival to cardiac transplantation if occurring before 180 days post-implant.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Carmat Total Artificial Heart Early Feasibility Study|
|Actual Study Start Date :||July 12, 2021|
|Estimated Primary Completion Date :||June 2023|
|Estimated Study Completion Date :||June 2023|
Subjects implanted with the Carmat TAH
Device: Carmat Total Artificial Heart
Heart replacement therapy
- Survival [ Time Frame: 180 days ]Proportion of patients surviving on the Carmat TAH
- Survival without Permanent Neurologic Deficit [ Time Frame: 180 days ]Proportion of patients surviving post implant without a permanent disabling stroke (Modified Rankin Scale >3)
- Post transplant survival [ Time Frame: 30 days ]Proportion of patients surviving 30 days post-transplant
- Change in functional status [ 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.
- Generic health status change [ 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.
Measured with the Kansas City Cardiomyopathy Questionnaire, a self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. Scores are transformed to a range of 0-100, in which higher scores reflect better health status.
- 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
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): NCT04117295
|United States, Kentucky|
|University of Louisville Jewish Hospital|
|Louisville, Kentucky, United States, 40202|
|United States, North Carolina|
|Duke University Medical Center|
|Durham, North Carolina, United States, 27710|
|United States, Texas|
|Baylor University Medical Center|
|Dallas, Texas, United States, 75226|
|United States, Virginia|
|VCU Medical Center|
|Richmond, Virginia, United States, 23298|