Heartsbreath Test for Heart Transplant Rejection

Validation of Heartsbreath Test for Heart Transplant Rejection

The purpose of this study is to demonstrate and validate a breath test for detection of biomarkers of heart transplant rejection (Grade 2R heart transplant).

This is a 36 month multi-center, open label, unblinded and blinded study on subjects have had a heart transplant within the previous 12 months and are scheduled to undergo an endomyocardial biopsy. The breath test will be performed to identify and validate the predicative algorithms that identify breath biomarkers for heart transplant rejection.

Inclusion Criteria:

• Subject is willing and able to cooperate with study, understand the scope of the study, and gives signed informed consent to participate.
• Subject is the recipient of a heart transplant within the previous 12 months
• Subject is scheduled for a routine endomyocardial biopsy
• Subject is 18 years or older

Exclusion Criteria:

• Evidence of acute intercurrent disease other than rejection reaction