CorWave LVAS FIH Study
ConditionAdvanced Heart Failure
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorCorWave
About this trial
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.
Eligibility criteria
Qualifiers
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%
Disqualifiers
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
Trial design
Treatments tested in this trial
- LVAS
Treatment groups
20 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov