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Bridge Occlusion Balloon in Lead Extraction Procedure

2016-03-22 06:23:23 | BioPortfolio

Summary

To evaluate the use of an occlusion balloon (Bridge™ Occlusion Balloon, Spectranetics) within the Superior Vena Cava in lead extraction patients.

Description

This study will evaluate the use of an occlusion balloon (Bridge™ Occlusion Balloon, Spectranetics) within the Superior Vena Cava in lead extraction patients. This will be performed in a non-emergent setting to allow for evaluation of how best to integrate this new technology into the investigators clinical practice. The study will focus on the effect of the Bridge balloon on the patient preparation clinical workflow, ease of insertion/positioning/deployment, and the ability to recognize proper inflation and vein sealing under fluoroscopy. Understanding these factors will help build a more robust clinical workflow with the goal of better patient outcomes in the case of an Superior Vena Cava injury. The images and data generated during this study can help in dissemination of the practical use knowledge to fellow lead extractors.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Conditions

C.Surgical Procedure; Cardiac

Intervention

Bridge Balloon

Location

University of Miami Hospital
Miami
Florida
United States
33125

Status

Not yet recruiting

Source

Yale University

Results (where available)

View Results

Links

Published on BioPortfolio: 2016-03-22T06:23:23-0400

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