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Bridge Occlusion Balloon in Lead Extraction Procedure

NCT02714153 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2021-06-14

Study results available
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Summary

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

Conditions

  • C.Surgical Procedure; Cardiac
  • Cardiac Dysrhythmia
  • Disorder of Pacing Function

Interventions

DEVICE

Bridge Balloon

The Bridge Balloon will be used 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.

Sponsors & Collaborators

  • Spectranetics Corporation

    collaborator INDUSTRY

  • Yale University

    lead OTHER

Principal Investigators

  • Jude Clancy, MD · Yale University

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-04-30
Primary Completion
2017-05-31
Completion
2017-10-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02714153 on ClinicalTrials.gov