Severe Biventricular End Stage Heart Disease Clinical Trial
Official title:
AbioCor Implantable Replacement Heart
| NCT number | NCT00669357 |
| Other study ID # | H040006 |
| Secondary ID | |
| Status | No longer available |
| Phase | N/A |
| First received | April 25, 2008 |
| Last updated | May 1, 2013 |
| Verified date | May 2013 |
| Source | Abiomed Inc. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Institutional Review Board |
| Study type | Expanded Access |
Abiocor is a post market approval study for an Implantable Replacement Heart. This post approval study is currently on hold.
| Status | No longer available |
| Enrollment | 0 |
| Est. completion date | |
| Est. primary completion date | |
| Accepts healthy volunteers | |
| Gender | Both |
| Age group | N/A to 75 Years |
| Eligibility |
Inclusion Criteria: - Patients in severe biventricular end stage heart disease who are not cardiac transplant candidates and who are adults less than 75 years old, require multiple inotropic support, are not treatable by LVAD destination therapy, and are not weanable from biventricular support if on such support. Exclusion Criteria: - Patients with other irreversible end organ dysfunctions that would compromise survival, having in clinical assessment a more than 30% chance of survival beyond 30 days, inadequate psychosocial support, or patients in whom fit is a problem, based on preoperative noninvasive anatomical assessment showing that the thoracic volume is unable to accommodate the device. |
N/A
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Abiomed Inc. |