Carmat Total Artificial Heart as a Bridge to Transplant in Patients With Advanced Heart Failure (NCT04475393) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Carmat Total Artificial Heart as a Bridge to Transplant in Patients With Advanced Heart Failure
France104 participantsStarted 2022-12-12
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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:
. 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)
Exclusion criteria
. Absolute contra-indication for heart transplant
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Survival free of disabling stroke and free of reoperation for device malfunction at 180 days post-implant
. 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.