EVAHEART LVAS Bridge-to-Transplant Pivotal Study
| Status: | Recruiting |
|---|---|
| Conditions: | Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 3/27/2019 |
| Start Date: | February 1, 2019 |
| End Date: | December 1, 2021 |
| Contact: | Director of Clinical Affairs |
| Email: | mdcruz@evaheart-usa.com |
| Phone: | 7135207979 |
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.
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
3
sites
500 S Preston St
Louisville, Kentucky
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...
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Dallas, Texas 75246
Principal Investigator: Dan Meyer, MD
Phone: 214-818-2588
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2001 West 86th Street
Indianapolis, Indiana 46260
Indianapolis, Indiana 46260
Principal Investigator: Ashwin Ravichandran
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