Bridge Occlusion Balloon in Lead Extraction Procedure

Yale University23 enrolled

Overview

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. 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 Type

INTERVENTIONAL

Allocation

Purpose

DEVICE_FEASIBILITY

Masking

NONE

Enrollment

Conditions

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

Interventions

Bridge BalloonDEVICE

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

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

Locations (7)

University of Miami Hospital

Miami, Florida, United States

Brigham and Women's Hospital

Boston, Massachusetts, United States

United Hospital

Saint Paul, Minnesota, United States

Cooper University Health Care

Camden, New Jersey, United States

Outcomes

Primary Outcomes

Number of Participants With Successful Balloon Occlusion of Superior Vena Cava

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.

Time frame: 33 minutes (average time)

Secondary Outcomes

Time of Bridge Balloon Deployment

Time will be calculated in seconds starting from opening the Bridge Balloon Package up to full balloon deployment.

Time frame: 33 minutes (average time)

Number of Participants With Changes in Heart Rate at One 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.

Time frame: 1 year

Number of Participants With Changes in Blood Pressure at One 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..

Time frame: 1 year

Number of Participants With Changes in SPO2 at One 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..

Data from ClinicalTrials.gov

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