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

NCT03228381 | Completed FDA Device

• 1 other identifier: BOSS CT005
• Study Type: interventional
• Target: 4
• Locations: 2 countries
• Sites: 3

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.

Conditions

Functional Mitral Regurgitation; Heart Failure

Keywords

Functional Mitral Regurgitation; Heart Failure

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

BOSS Device

EXPERIMENTAL

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

Interventions

BOSS Device 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.

BOSS Device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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)

Sponsors & Collaborators

• Mardil Medical: lead

Study Sites (3)

Henry Ford Health System

Detroit, Michigan, 48202, United States

Location

Minneapolis Heart Institute at Abbott Northwestern Hospital

Minneapolis, Minnesota, 55407, United States

Location

Sanatorio Italiano

Asunción, Paraguay

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Sarah Hase

  Mardil Medical

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2017
• First Posted: July 24, 2017
• Study Start: August 21, 2017
• Primary Completion: October 16, 2017
• Study Completion: October 16, 2017
• Last Updated: April 3, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2); PA (1)