CorWave LVAS FIH Study

First In Human Clinical Study of the CorWave Left Ventricular Assist System for the Treatment of Patients With Advanced Heart Failure

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.

Study Overview

• Status: Recruiting
• Conditions: Advanced Heart Failure
• Intervention / Treatment: Device: LVAS

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Gabriella Giaquinta; Phone Number: +49 151 129 68474; Email: gabriella.giaquinta@corwave.com

Study Locations

• Australia
  • New South Wales
    • Sydney, New South Wales, Australia, 2010
      • Recruiting
      • St Vincent's Hospital Sydney
  • Victoria
    • Melbourne, Victoria, Australia, 3004
      • Recruiting
      • Bayside Health
      • Contact: Marasco; Phone Number: +61 3 90762558; Email: s.marasco@alfred.org.au

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 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.
• Patient has known hypo or hyper coagulable states such as disseminated intravascular coagulation and heparin induced thrombocytopenia.
• Participation in any other clinical investigation that is likely to confound study results or affect the study.
• Any condition other than HF that could limit survival to less than 12 months.
• Acute myocardial infarction within 14 days of implant as diagnosed by ST elevation (STEMI) changes on ECG, diagnostic biomarkers, and hemodynamic abnormalities. Planned or carried out coronary revascularizations (including PCI requiring (dual) antiplatelet therapies).
• Pulmonary embolus within 6 weeks of implant as documented by computed tomography (CT) scan or nuclear scan.
• Subject is unwilling or unable to comply with trial requirements.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Subjects implanted with CorWave LVAD	Device: LVAS; Implantation and use of the CorWave LVAS to evaluate the safety and effectiveness of the CorWave LVAD to treat advanced left ventricular heart failure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Survival post-implant	Survival at 30 days post index procedure.	30 days
Freedom from adverse events associated with CorWave LVAD	Freedom from adverse events associated with the use of the CorWave LVAD through 30 days post LVAD implant defined as non-surgical bleeding, infection, disabling stroke and pump malfunction, as defined by INTERMACS.	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival	Survival to transplant or of LVAD support	up to 2 years
Freedom from non-surgical bleeding	Freedom from non-surgical bleeding (as defined by INTERMACS)	180 days
Freedom from infection	Freedom from infection (as defined by INTERMACS)	180 days
Freedom from debilitating stroke	Freedom from debilitating stroke (Modified Rankin Score >3) at 180 days	180 days
Health-related Quality of Life	Quality of Life measured by EuroQoL (EQ-5D)	up to 2 years
Health-related Quality of Life	Health-related quaulity of life as measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ)	up to 2 years
Neurocognitive function	Neurocognitive function indicated by the Trail-making B test	up to 2 years
Functional status	Functional status as measured by NYHA classification	up to 2 years
Functional status	Measured by 6-minute walk test	up to 2 years
Adverse Events rates	Adverse Events rates, as defined per INTERMACS	up to 2 years

Collaborators and Investigators

• Sponsor: CorWave

Study record dates

Study Major Dates

• Study Start (Actual): May 6, 2025
• Primary Completion (Estimated): May 1, 2026
• Study Completion (Estimated): May 1, 2028

Study Registration Dates

• First Submitted: March 21, 2025
• First Submitted That Met QC Criteria: March 31, 2025
• First Posted (Actual): April 2, 2025

Study Record Updates

• Last Update Posted (Actual): February 9, 2026
• Last Update Submitted That Met QC Criteria: February 6, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Heart Failure
• Other Study ID Numbers: CT-2023-CTN-01360-1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No