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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06907017




Registration number
NCT06907017
Ethics application status
Date submitted
21/03/2025
Date registered
2/04/2025
Date last updated
24/08/2025

Titles & IDs
Public title
CorWave LVAS FIH Study
Scientific title
First In Human Clinical Study of the CorWave Left Ventricular Assist System for the Treatment of Patients With Advanced Heart Failure
Secondary ID [1] 0 0
CT-2023-CTN-01360-1
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Advanced Heart Failure 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - LVAS

Experimental: Subjects implanted with CorWave LVAD -


Treatment: Devices: 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.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Survival post-implant
Timepoint [1] 0 0
30 days
Primary outcome [2] 0 0
Freedom from adverse events associated with CorWave LVAD
Timepoint [2] 0 0
30 days
Secondary outcome [1] 0 0
Overall survival
Timepoint [1] 0 0
up to 2 years
Secondary outcome [2] 0 0
Freedom from non-surgical bleeding
Timepoint [2] 0 0
180 days
Secondary outcome [3] 0 0
Freedom from infection
Timepoint [3] 0 0
180 days
Secondary outcome [4] 0 0
Freedom from debilitating stroke
Timepoint [4] 0 0
180 days
Secondary outcome [5] 0 0
Health-related Quality of Life
Timepoint [5] 0 0
up to 2 years
Secondary outcome [6] 0 0
Health-related Quality of Life
Timepoint [6] 0 0
up to 2 years
Secondary outcome [7] 0 0
Neurocognitive function
Timepoint [7] 0 0
up to 2 years
Secondary outcome [8] 0 0
Functional status
Timepoint [8] 0 0
up to 2 years
Secondary outcome [9] 0 0
Functional status
Timepoint [9] 0 0
up to 2 years
Secondary outcome [10] 0 0
Adverse Events rates
Timepoint [10] 0 0
up to 2 years

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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
* 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 design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
6/05/2025
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/09/2027
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
St Vincent's Hospital Sydney - Sydney
Recruitment postcode(s) [1] 0 0
2010 - Sydney

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
CorWave
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Gabriella Giaquinta
Address 0 0
Country 0 0
Phone 0 0
+49 151 129 68474
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT06907017