Last updated on October 2016

Bridge Occlusion Balloon in Lead Extraction Procedure


Brief description of study

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

Detailed Study 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.

Clinical Study Identifier: NCT02714153

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Roger Carrillo, MD

University of Miami Hospital
Miami, FL United States
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Roy John, MD

Brigham and Women's Hospital
Boston, MA United States
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Pierce Vatterott, MD

United Hospital
St.Paul, MN United States
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John Andriulli, MD

Cooper University Health Care
Camden, NJ United States
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Rohit Mehta, MD

Sanger Heart & Vascular Institute Carolinas HealthCare System
Charlotte, NC United States
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Jonathan Piccini, MD

Duke University Medical Center
Durham, NC United States
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Bruce Wilkoff, MD

Cleveland Clinic
Cleveland, OH United States
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