This trial is no longer in process.
| Summary of Trial: | The AbioCor is indicated for use in severe biventricular end-stage heart disease patients who are not heart transplant candidates and are no older than 75 years old. The device is approved by the Food and Drug Administration under the Humanitarian Device Exemption (HDE) which means that the FDA has deemed the device safe and can offer some benefit. The purpose of the post approval study is to assess the safety and potential effectiveness of the device in the clinical setting. |
| Principal Investigators: | Drs. John Conte, Stuart Russell and Ashish Shah |
| Study Coordinators: | Dzifa Dordunoo, MSN, RN Tamara Bubb, BS |
| Study Long Title: | A Post-Approval Study (PAS) to Monitor the Clinical Performance of the AbioCor in Severe End-stage Heart Disease Patients |
| Study Short Title: | N/A |
| JHU eIRB Number: | NA_00010458 |
| Funding Source: | ABIOMED, Inc. |
| Inclusions: | Patients who are less than 75 years old and
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Exclusions: |
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| Clinical Trial Site: | Johns Hopkins Hospital 600 North Wolfe Street, Blalock 618 Baltimore, MD 21287-4618 This is a multi-center – there are 4 sites across the U.S. that are participating in this clinical trial. |
| Start Date: | February 2008 |
| Anticipated End Date: | N/A |
| Compensation for Participating: | None |
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