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Advanced Heart FailureNCT06907017

CorWave LVAS FIH Study

A study testing LVAS in people with Advanced Heart Failure, run by CorWave at 3 sites in 2 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Advanced Heart Failure
What is being tested?
LVAS
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
3 sitesin 2 countries
Study dates
6 May 2025to May 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
Show all 10Show fewer
  • 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.

Who cannot join

  • 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
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  • 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.

Trial locations and contacts

3 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

Gabriella Giaquinta contact

+49 151 129 68474

gabriella.giaquinta@corwave.com

3 sites in 2 countries

Australia2 sites, 2 recruiting

  • Bayside Health

    Melbourne, Victoria, 3004

    Marasco, +61 3 90762558, s.marasco@alfred.org.au

    Recruiting

  • St Vincent's Hospital Sydney

    Sydney, New South Wales, 2010

    Recruiting

Other trials in Australia

Kazakhstan1 site, 1 recruiting

  • University Medical Center Heart Center

    Astana, 010000

    Sadyk Khamitov, +77172703153, cardiacsurgeryres@gmail.com

    Recruiting

Other trials in Kazakhstan

About this study

Official title: 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.

Being tested
LVAS

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LVASDevice

    Implantation and use of the CorWave LVAS to evaluate the safety and effectiveness of the CorWave LVAD to treat advanced left ventricular heart failure.

Study groups in NCT06907017
Study groupRoleWhat they receive
Subjects implanted with CorWave LVADExperimentalNot described
Receives: Device: LVAS

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Survival post-implant

    Survival at 30 days post index procedure.

    Measured: 30 days

  2. 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.

    Measured: 30 days

Secondary outcomes (10)

  1. Overall survival

    Survival to transplant or of LVAD support

    Measured: up to 2 years

  2. Freedom from non-surgical bleeding

    Freedom from non-surgical bleeding (as defined by INTERMACS)

    Measured: 180 days

  3. Freedom from infection

    Freedom from infection (as defined by INTERMACS)

    Measured: 180 days

  4. Freedom from debilitating stroke

    Freedom from debilitating stroke (Modified Rankin Score >3) at 180 days

    Measured: 180 days

  5. Health-related Quality of Life

    Quality of Life measured by EuroQoL (EQ-5D)

    Measured: up to 2 years

  6. Health-related Quality of Life

    Health-related quaulity of life as measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ)

    Measured: up to 2 years

  7. Neurocognitive function

    Neurocognitive function indicated by the Trail-making B test

    Measured: up to 2 years

  8. Functional status

    Functional status as measured by NYHA classification

    Measured: up to 2 years

  9. Functional status

    Measured by 6-minute walk test

    Measured: up to 2 years

  10. Adverse Events rates

    Adverse Events rates, as defined per INTERMACS

    Measured: up to 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Apr 2025
  2. Study start6 May 2025
  3. Primary completionAug 2026 (estimated)
  4. Study completionMay 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06907017
Sponsor's protocol ID
CT-2023-CTN-01360-1
Status last verified
Feb 2026
First submitted
21 Mar 2025
Last updated
3 Aug 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing LVAS in people with Advanced Heart Failure, run by CorWave at 3 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 3 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Australia, Kazakhstan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Gabriella Giaquinta (+49 151 129 68474, gabriella.giaquinta@corwave.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Survival post-implant (time frame: 30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06907017.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2026.

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CorWave LVAS FIH Study (NCT06907017) | AzTrials