AbioCor Implantable Replacement Heart

Abiomed

Status

Conditions: Severe Biventricular End Stage Heart Disease

Treatments: Device: Abiocor Implantable Replacement Heart

Study type: Expanded Access

Funder types: Industry

Identifiers

NCT00669357

H040006

Details and patient eligibility

About

Abiocor is a post market approval study for an Implantable Replacement Heart. This post approval study is currently on hold.

Sex: All

Ages: Under 75 years old

Volunteers: No Healthy Volunteers

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.