NCT06907017

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
24mo left

Started May 2025

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress34%
May 2025May 2028

First Submitted

Initial submission to the registry

March 21, 2025

Completed
12 days until next milestone

First Posted

Study publicly available on registry

April 2, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

May 6, 2025

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2026

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2028

Expected
Last Updated

February 9, 2026

Status Verified

February 1, 2026

Enrollment Period

12 months

First QC Date

March 21, 2025

Last Update Submit

February 6, 2026

Conditions

Advanced Heart Failure

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (10)

  • Overall survival

    up to 2 years

  • Freedom from non-surgical bleeding

    180 days

  • Freedom from infection

    180 days

  • Freedom from debilitating stroke

    180 days

  • Health-related Quality of Life

    up to 2 years

  • +5 more secondary outcomes

Study Arms (1)

Subjects implanted with CorWave LVAD

EXPERIMENTAL
Device: LVAS

Interventions

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.

Subjects implanted with CorWave LVAD

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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
  • +16 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

St Vincent's Hospital Sydney

Sydney, New South Wales, 2010, Australia

RECRUITING

Bayside Health

Melbourne, Victoria, 3004, Australia

RECRUITING

Central Study Contacts

Gabriella Giaquinta

CONTACT

+49 151 129 68474gabriella.giaquinta@corwave.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 21, 2025

First Posted

April 2, 2025

Study Start

May 6, 2025

Primary Completion

May 1, 2026

Study Completion (Estimated)

May 1, 2028

Last Updated

February 9, 2026

Record last verified: 2026-02

Locations

AU(2)