Health Trials

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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • LVAS

    Device

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

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: Subjects implanted with CorWave LVADExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Survival post-implant

Survival at 30 days post index procedure.

Time frame
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.

Time frame
30 days

Secondary outcomes

1

Overall survival

Survival to transplant or of LVAD support

Time frame
up to 2 years
2

Freedom from non-surgical bleeding

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

Time frame
180 days
3

Freedom from infection

Freedom from infection (as defined by INTERMACS)

Time frame
180 days
4

Freedom from debilitating stroke

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

Time frame
180 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

CorWave

Lead sponsor

Source ClinicalTrials.gov
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