The BOSS Study: An Acute Evaluation of Anatomical and Geometric Changes Using the Bladder on a Stick System (BOSS)

Completed · Not applicable

Conditions studied: Functional Mitral Regurgitation, Heart Failure

In brief

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.

Key facts

Study ID

NCT03228381

Run by

Mardil Medical

People needed

4

Starts

2017-08-21

Expected to finish

2017-10-16

Last updated by the study team

2018-04-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• 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)

Where it is running

• Henry Ford Health System — Detroit, Michigan, United States
• Minneapolis Heart Institute at Abbott Northwestern Hospital — Minneapolis, Minnesota, United States
• Sanatorio Italiano — Asunción, Paraguay

Full record on ClinicalTrials.gov

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