EVAHEART LVAS Bridge-to-Transplant Pivotal Study

Therapuetic Areas:Cardiology / Vascular Diseases
Age Range:18 - Any
Start Date:February 1, 2019
End Date:December 1, 2021
Contact:Director of Clinical Affairs

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A Prospective Study to Evaluate the Safety and Efficacy of the EVAHEART LVAS for Use as a Bridge-to-Transplant

The objective of this pivotal study is to assess the safety and efficacy of the EVAHEART LVAS
as a bridge-to-transplant for subjects with end stage heart failure. Subjects will be
followed for 180 days after the EVAHEART LVAS implant or until cardiac transplant or explant
for recovery (+ 60 days or discharge). If after 180 days post-implant the subject has not
received a cardiac transplant or the device has not been explanted, the subject will continue
to be followed monthly.

Inclusion Criteria:

The following is a list of general inclusion criteria:

- Age ≥ 18 years

- Listed for cardiac transplant as a status 1A or 1B

- NYHA Class IV heart failure

- Patient is able to provide written informed consent

- More detailed inclusion criteria information is noted in the study protocol

Exclusion Criteria:

The following is a list of general exclusion criteria:

- Active, uncontrolled infection

- BSA < 1.4 m²

- Irreversible organ failure

- Severe right ventricular failure

- Prosthetic mechanical aortic or mitral valve

- Patients with an unacceptable risk for successful LVAD implantation and maintenance

- Patients refusing blood transfusion

- Intolerant of anticoagulation therapy

- Coagulopathy

- Active psychiatric disorder, irreversible cognitive dysfunction or other psychosocial
behavior that impairs the ability of the patient to follow instructions, maintain
their device or their medical regimen

- Pregnancy

- Current dependence on other mechanical circulatory support device at the time of
implant, other than IABP

- Presence of condition other than heart failure that would limit survival to less than
3 years

- More detailed exclusion criteria information is noted in the study protocol
We found this trial at
Dallas, Texas 75246
Principal Investigator: Dan Meyer, MD
Phone: 214-818-2588
Dallas, TX
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2001 West 86th Street
Indianapolis, Indiana 46260
Principal Investigator: Ashwin Ravichandran
Indianapolis, IN
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500 S Preston St
Louisville, Kentucky
(502) 852-5555
Principal Investigator: Mark Slaughter, MD
University of Louisville The University of Louisville is a state supported research university located in...
Louisville, KY
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