Status:
COMPLETED
The BOSS Study: An Acute Evaluation of Anatomical and Geometric Changes Using the Bladder on a Stick System (BOSS)
Lead Sponsor:
Mardil Medical
Conditions:
Functional Mitral Regurgitation
Heart Failure
Eligibility:
All Genders
18+ years
Phase:
NA
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 ...
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, corre...
Eligibility Criteria
Inclusion
- Adults ≥18 years of age
- Patient undergoing open chest cardiac surgery via sternotomy
- Signed informed consent by patient or legally authorized representative
Exclusion
- 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)
Key Trial Info
Start Date :
August 21 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 16 2017
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT03228381
Start Date
August 21 2017
End Date
October 16 2017
Last Update
April 3 2018
Active Locations (3)
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1
Henry Ford Health System
Detroit, Michigan, United States, 48202
2
Minneapolis Heart Institute at Abbott Northwestern Hospital
Minneapolis, Minnesota, United States, 55407
3
Sanatorio Italiano
Asunción, Paraguay