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

Heart Failure Clinical Trial

— BOSS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03228381
• Other study ID #: BOSS CT005
• Status: Completed
• Phase: N/A
• First received: July 17, 2017
• Last updated: April 2, 2018
• Start date: August 21, 2017
• Est. completion date: October 16, 2017

Study information

• Verified date: April 2018
• Source: Mardil Medical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4
• Est. completion date: October 16, 2017
• Est. primary completion date: October 16, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Functional Mitral Regurgitation
• Heart Failure
• Mitral Valve Insufficiency

Intervention

Device:
• BOSS 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.

Locations

Country	Name	City	State
Paraguay	Sanatorio Italiano	Asuncion
United States	Henry Ford Health System	Detroit	Michigan
United States	Minneapolis Heart Institute at Abbott Northwestern Hospital	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mardil Medical

Countries where clinical trial is conducted

United States,  Paraguay, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acute anatomical changes assessed by echocardiography	Anatomical annular and ventricular changes assessed by echocardiography, such as shape and deformation of the mitral valve annulus and left ventricular wall	At Procedure
Primary	Acute geometric changes measured by echocardiography	Geometric annular and ventricular changes measured by echocardiography, such as reductions in septal-lateral dimension and left ventricular end diastolic diameter (LVEDD)	At Procedure