The study is a prospective, multi-center, non-randomized trial to evaluate the safety and effectiveness of the CorWave LVAS for the treatment of advanced heart failure patients.
Who can participate
Age range
18 Years – 75 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:
* Subject or legal representative has signed Informed Consent Form
* Age \> 18 and \< 75 years old
* Body Surface Area (BSA) ≥ 1.2 m2
* Left Ventricular Ejection Fraction (LVEF) ≤ 35%
* Inotrope dependent OR
* Cardiac Index (CI) \< 2.2 L/min/m2, while not on inotropes and subjects must also meet one of the following criteria:
* On Guideline Directed Medical Therapy (GDMT) for at least 45 out of the last 60 days and are failing to respond.
* Advanced heart failure (Class III or Class IV for at least 14 days AND support from short term mechanical circulatory support for up to 7 days).
* Females of childbearing age must agree to use adequate contraception.
* Patient must be eligible for heart transplantation.
Exclusion Criteria:
* Heart failure (HF) due to or associated with uncorrected thyroid disease, obstructive cardiomyopathy, pericardial disease, amyloidosis or restrictive cardiomyopathy.
* Technical obstacles which pose an inordinately high surgical risk, in the judgment of the Investigator
* Ongoing mechanical circulatory support (MCS) other than IABP or micro axial pumps
* INTERMACS Class I patients
* Subject is on a ventilator
* Subject is pregnant or breastfeeding
* Presence of a mechanical aortic valve that will not be converted to a bioprosthesis at the time of LVAD implant
* History of any organ transplant
* Platelet count \< 100,000/μl
* Psychiatric disease/disorder, illicit drug use, irreversible cognitive dysfunction or psychosocial is…
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 post-implant
Timeframe: 30 days
2
Freedom from adverse events associated with CorWave LVAD