The objective of the BOSS Study is to assess acute anatomical and geometric annular and ventricular changes that occur when strategically positioned an external inflatable chambers are applied to the outside of the heart.

Mardil Medical is developing an investigational device for functional mitral regurgitation intended to provide ventricular support with adjustable inflatable chambers to reduce annular dilation, correct papillary muscle displacement, and restore mitral valve leaflet coaptation. In doing so, Mardil Medical is interested in exploring the anatomical and geometric annular and ventricular changes that occur when strategically positioned external inflatable chambers are applied to the outside of the heart. Favorable benefits of circumferential reduction in ventricular wall stress favoring left ventricular (LV) remodeling and acute reshaping of LV segments subtending the deformed mitral valve apparatus needs to be better understood. Mardil Medical is pursuing this study as an initial phase in the Acute Evaluation of Anatomical and Geometric Changes using the Bladder on a Stick System (BOSS).

Inclusion Criteria:

• Adults ≥18 years of age
• Patient undergoing open chest cardiac surgery via sternotomy
• Signed informed consent by patient or legally authorized representative

Exclusion Criteria:

• Any procedure, condition or cardiac anatomy that may impact or compromise the pericardial space (e.g. prior valve surgery, CABG, epicardial pacing leads, pericarditis, history of mantle radiation, or other procedure involving pericardial access)

There are no plans to make individual participant data (IPD) available to other researchers.