A Clinical Study of the CorWave® Left Ventricular Assist System For the treatment of patients with advanced heart failure (NCT06907017)

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. Trial aim: implantation and use of the CorWave LVAS to evaluate the safety and effectiveness of the CorWave LVAD to treat advanced left ventricular heart failure.

Trial phase

Phase 1

Trial participation type

This trial has been designed for the Clinical Research of a Device.

Principal investigator

Prof Silvana Marasco

Key inclusion data

Key inclusion criteria: 18-75 years old; Body Surface Area (BSA) = 1.2 m2; 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); Patient must be eligible for heart transplantation. Key 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; Subject is on a ventilator; Subject is pregnant or breastfeeding; History of any organ transplant; 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.