IRB Number:

811-05

Trial Status:

Open for Enrollment

Phase: I

Why is this study being done?

To assess the safety and efficacy of the Jarvik 2000® Heart Assist System. To determine if it can be safely implanted and support the heart's circulation until a suitable donor heart becomes available.

Who is Eligible to Participate in the Study?

This study involves adult patients over 18 years of age with severe end-stage heart failure awaiting heart transplant.

Minimum Age:

18

Maximum Age:

74

What is Involved With this Study?

When a patient enrolls in this study they must be heart transplant-listed with UNOS status 1A or 1B. The results from their clinically indicated medical tests and physical exams are collected before surgery, during implant, and until they are transplanted. They will have data-collection from follow-up visits as clinically indicated until the device is removed.

How long will the Study run?

Data will be collected on patients for 180 days or until transplant or device removal.

Who can I Contact for Additional Information on this Trial?

cvsurgresearch@mayo.edu.">For more information or to participate in this research study, please contact Susan M. Nelson at (507) 255-4670 or send an e-mail to: cvsurgresearch@mayo.edu.

What is/are the Locations of this Clinical Trial?

• Rochester, MN
• Jacksonville, FL

Last updated: 07/03/2006