Bridge Occlusion Balloon in Lead Extraction Procedure

Not Applicable

Completed

• Conditions: C.Surgical Procedure; Cardiac; Disorder of Pacing Function; Cardiac Dysrhythmia
• Interventions: Device: Bridge Balloon

• Registration Number: NCT02714153
• Lead Sponsor: Yale University

Brief Summary

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

Detailed 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.

At the time of the protocol registration, the timeframe 12 months was entered, this was actually the anticipated length of the study at registration. The timeframe was corrected to 33 minutes (average time) at the time of results entry.

Study Timeline

• Study First Submitted: 2016-03-04
• Study First Submitted QC: 2016-03-15
• Study First Posted: 2016-03-21
• Study Start: 2016-04
• Primary Completion: 2017-05
• Study Completion: 2017-10
• Results First Submitted: 2020-08-19
• Results First Submitted QC: 2021-03-10
• Results First Posted: 2021-04-06
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-19
• Last Update Posted: 2021-06-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

Inclusion Criteria

• Subject age more than 18 years
• Lead extraction patients

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Bridge Occlusion Balloon	Bridge Balloon	Bridge Balloon catheter is designed to be used for temporary vessel occlusion of the superior vena cava in applications including perioperative occlusion and emergency control of hemorrhage associated with vascular tears that may occur during lead extraction procedures.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Successful Balloon Occlusion of Superior Vena Cava	33 minutes (average time)	After Bridge Balloon deployment and inflation, the degree of blood vessel occlusion will be reported. Measurements will be calculated from fluoroscopic images (using x-ray machine) and venograms (images with injection of contrast agent). Successful balloon occlusion of the superior vena cava (SVC) is defined as \>90% occlusion of the SVC by visual estimate using conventional venography.

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Changes in Blood Pressure at One Year	1 year	Blood pressure in mmHg will be collected at 5 points: baseline, after guidewire insertion, at the time of balloon inflation, immediately post deflation and 5 minutes post deflation (all during the procedure itself). This outcome will be reported at the end of the study as as if there were any unacceptable or no unacceptable changes in the hemodynamics over the course of the 12 month period..
Number of Participants With Changes in SPO2 at One Year	1 year	SPO2 will be collected at 5 points: baseline, after guidewire insertion, at the time of balloon inflation, immediately post deflation and 5 minutes post deflation (all during the procedure itself). This outcome will be reported at the end of the study as if there were any unacceptable or no unacceptable changes in the hemodynamics over the course of the 12 month period..
Time of Bridge Balloon Deployment	33 minutes (average time)	Time will be calculated in seconds starting from opening the Bridge Balloon Package up to full balloon deployment.
Number of Participants With Changes in Heart Rate at One Year	1 year	Heart Rate (in beat per minute) will be collected at 5 points: baseline, after guidewire insertion, at the time of balloon inflation, immediately post deflation and 5 minutes post deflation (all during the procedure itself). This outcome will be reported at the end of the study as if there were any unacceptable or no unacceptable changes in the hemodynamics over the course of the 12 month period.

Trial Locations

Locations (7)

Cleveland Clinic; 🇺🇸 Cleveland, Ohio, United States

University of Miami Hospital; 🇺🇸 Miami, Florida, United States

United Hospital; 🇺🇸 Saint Paul, Minnesota, United States

Brigham and Women's Hospital; 🇺🇸 Boston, Massachusetts, United States

Cooper University Health Care; 🇺🇸 Camden, New Jersey, United States

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States

Sanger Heart & Vascular Institute Carolinas HealthCare System; 🇺🇸 Charlotte, North Carolina, United States