Heartsbreath Test for Heart Transplant Rejection

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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Validation of Heartsbreath Test for Heart Transplant Rejection

Conditions
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Heart Transplant Rejection

Intervention / Treatment
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* Device: BreathScanner 1.0
* Device: BreathLink


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>Subjects will comprise of patients who are the recipients of a heart transplant within the previous 12 months and are scheduled for a routine endomyocardial biopsy. Subjects will provide breath samples for the Heartsbreath test using the BreathScanner 1.0. Optionally subjects will provide breath samples using the BreathLink point of care system. | Device: BreathScanner 1.0<br>* For the HeartsBreath test, breath is collected using BreathScanner 1.0 and sent to central laboratory for analysis for markers of transplant rejection.<br>Device: BreathLink<br>* The BreathLink point-of-care system detects and quantifies the breath VOC's determined to be biomarkers during the development of the Heartsbreath test.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To measure the sensitivity and specificity of the breath test as compared to the primary right ventricular endomyocardial biopsy for the development of an intrinsically safe, painless, and non-invasive detection technique. | The current gold standard for heart transplant rejection diagnosis is a series of endomyocardial biopsies during the first twelve months after operation. This procedure is invasive, painful, and potentially hazardous. The Heartsbreath test is an intrinsically safe, painless, and non-invasive breath test for heart transplant rejection that employs volatile biomarkers of oxidative stress. The Food & Drug Administration (FDA) approved the Heartsbreath test for clinical use with a Humanitarian Device Exemption (HDE). | 60 days after completion | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rejection of the Heart Transplant, Heart Transplant Rejection, an immune-mediated allograft injury, Non-cellular or humoral rejection in cardiac transplant recipients, Right ventricular endomyocardial biopsy to detect Heart transplant rejection