Clinical Trial TitleCARILLON: Assessment of the CARILLON Mitral Contour System in treating functional mitral regurgitation associated with heart failure.
Clinical Trial Protocol Description:
The purpose of this study is to evaluate the safety and effectiveness of the CARILLON Mitral Contour System in people who have mitral regurgitation (mitral valve leakage) resulting from heart failure. The CARILLON implant is an investigational device that is permanently implanted in the great cardiac vein and coronary sinus (blood vessels) located next to the mitral valve on the outer surface of the heart. Eligible patients will be randomly assigned to receive either the CARILLON implant or undergo a coronary angiogram (no implant). After one year of participation, the patients who were randomized to the control group (no implant) may be eligible to receive the CARILLON implant.
Clinical Trial Eligibility Criteria:
In order to participate you must meet the following criteria:
- Are 18-85 years of age.
- Have been diagnosed with functional mitral regurgitation.
- Have been diagnosed with dilated ischemic or non-ischemic cardiomyopathy.
- Have a left ventricular ejection fraction ≤ 50%.
This is a partial list of inclusion and exclusion criteria. To inquire about your eligibility, please call the contact number provided. If you wish to inquire via email, please include the title of the study in your message.