Functional Mitral Regurgitation, Heart Failure
Conditions
Keywords
Functional Mitral Regurgitation, Heart Failure
Brief summary
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.
Detailed description
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).
Interventions
DEVICEBOSS Device
The BOSS will be comprised of a flexible, medical grade silicone handle and interchangeable inflatable medical grade silicone chambers. The inflatable chambers will vary in geometry and will have silicone tubing attached to them to allow inflation and deflation of the chamber while in the pericardial space. During open chest cardiac surgery, a small incision will be made in the pericardium to allow for insertion of the BOSS device into the pericardial space. Once inserted, the BOSS device will be positioned in different locations around the outside of the heart and anatomical and geometric changes will be observed echocardiographically. Use of the BOSS device is expected to lengthen the procedure by an average of 15 minutes, and in rare instances may be extended beyond 15 minutes as deemed appropriate by the investigator. The BOSS will be removed prior to continuing with the planned surgery.
Sponsors
Mardil Medical
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acute anatomical changes assessed by echocardiography | At Procedure | Anatomical annular and ventricular changes assessed by echocardiography, such as shape and deformation of the mitral valve annulus and left ventricular wall |
| Acute geometric changes measured by echocardiography | At Procedure | Geometric annular and ventricular changes measured by echocardiography, such as reductions in septal-lateral dimension and left ventricular end diastolic diameter (LVEDD) |
Countries
Paraguay, United States
Outcome results
None listed