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

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

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.

Study Overview

• Status: Completed
• Conditions: Heart Failure; Functional Mitral Regurgitation
• Intervention / Treatment: Device: BOSS Device

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).

• Study Type: Interventional
• Enrollment (Actual): 4
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Paraguay
  • Asuncion, Paraguay
    • Sanatorio Italiano
• United States
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Henry Ford Health System
  • Minnesota
    • Minneapolis, Minnesota, United States, 55407
      • Minneapolis Heart Institute at Abbott Northwestern Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: BOSS Device; Patients who are undergoing open chest cardiac surgery via sternotomy will receive the BOSS device 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.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Mardil Medical
• Investigators: Study Director: Sarah Hase, Mardil Medical

Study record dates

Study Major Dates

• Study Start (Actual): August 21, 2017
• Primary Completion (Actual): October 16, 2017
• Study Completion (Actual): October 16, 2017

Study Registration Dates

• First Submitted: July 17, 2017
• First Submitted That Met QC Criteria: July 20, 2017
• First Posted (Actual): July 24, 2017

Study Record Updates

• Last Update Posted (Actual): April 3, 2018
• Last Update Submitted That Met QC Criteria: April 2, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: Heart Failure; Functional Mitral Regurgitation
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Valve Diseases; Heart Failure; Mitral Valve Insufficiency
• Other Study ID Numbers: BOSS CT005

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There are no plans to make individual participant data (IPD) available to other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes