Bridge Occlusion Balloon in Lead Extraction Procedure



Status:Completed
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - 85
Updated:1/13/2018
Start Date:April 2016
End Date:October 2017

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Bridge Occlusion Balloon Initial Use in Humans Study

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

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.

Inclusion Criteria:

- Subject age more than 18 years

- Lead extraction patients

Exclusion Criteria:

Lead extraction patients with:

- Superior Vena Cava occlusion or stenosis.

- Significant vegetation.

- Hemodynamic instability.

- Class IV heart failure

- Creatinine > 2.0mg/dL

- Patients > 85 years old
We found this trial at
7
sites
9500 Euclid Avenue
Cleveland, Ohio 44106
216.444.2200
Principal Investigator: Bruce Wilkoff, MD
Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
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Cleveland, OH
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75 Francis street
Boston, Massachusetts 02115
(617) 732-5500
Principal Investigator: Roy John, MD
Brigham and Women's Hosp Boston’s Brigham and Women’s Hospital (BWH) is an international leader in...
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Boston, MA
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Camden, New Jersey 08103
Principal Investigator: John Andriulli, MD
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Camden, NJ
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Charlotte, North Carolina 28203
Principal Investigator: Rohit Mehta, MD
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Charlotte, NC
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2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
Principal Investigator: Jonathan Piccini, MD
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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Durham, NC
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1400 NW 12th Ave
Miami, Florida 33136
(305) 689-5511
Principal Investigator: Roger Carrillo, MD
University of Miami Hospital The University of Miami changed the face of modern health care...
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mi
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Miami, FL
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333 Smith Ave
Saint Paul, Minnesota 55102
(651) 241-8000
United Hospital United Hospital is the largest hospital in the Twin Cities east metro area,...
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Saint Paul, MN
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