CorWave LVAS FIH Study

Recruiting now · Not applicable

Conditions studied: Advanced Heart Failure

In brief

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.

Key facts

Study ID

NCT06907017

Run by

CorWave

People needed

20

Starts

2025-05-06

Expected to finish

2028-05-01

Last updated by the study team

2026-08-03

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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 issues that are likely to impair compliance with the study protocol and LVAD management
• History of confirmed untreated abdominal aortic aneurysm (AAA) > 5 cm in diameter within 6 months of enrollment
• Presence of an active, uncontrolled infection
• Intolerance to anticoagulant or antiplatelet therapies or any other peri/post-operative therapy the investigator will require based upon the patient's health status
• Presence of any one of the following risk factors for indications of severe end organ dysfunction or failure:
• An INR ≥ 2.0 not due to anticoagulation therapy
• Total bilirubin > 43 µmol/L (2.5 mg/dL), liver function tests greater than 3 times the establish laboratory normal, including Serum Albumin below 3.5 g/dl, shock liver, or biopsy proven liver cirrhosis
• History of severe chronic obstructive pulmonary disease (COPD) and restrictive disease (fibrosis); FEV1 < 50%, a total FEV1 below 1000 mL and a DLCO < 50% predicted.
• Fixed pulmonary hypertension with a most recent PVR ≥ 8 Wood units that is unresponsive to pharmacologic intervention
• History of stroke within 90 days prior to enrollment, or a history of cerebrovascular disease with significant (> 50%) uncorrected carotid stenosis
• Serum creatinine ≥ 221 µmol/L (2.5 mg/dL) or the need for chronic renal replacement therapy.
• Ongoing patient malnutrition evidenced by nonintentional weight loss of greater than 5% of body mass in the previous 30 days, prealbumin < 16 mg/dL, or Mini Nutritional Assessment score < 17.
• Poorly controlled diabetes mellitus or a hemoglobin A1c > 8.5%.
• Significant peripheral vascular disease (PVD) accompanied by rest pain or extremity ulceration.
• Patient has severe aortic insufficiency without plans for correction during pump implant.
• Planned Bi-VAD support prior to enrollment.

Where it is running

• St Vincent's Hospital Sydney — Sydney, New South Wales, Australia (enrolling)
• Bayside Health — Melbourne, Victoria, Australia (enrolling)
• University Medical Center Heart Center — Astana, Kazakhstan (enrolling)

Full record on ClinicalTrials.gov

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