Bridge Occlusion Balloon in Lead Extraction Procedure

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.

Study Overview

• Status: Completed
• Conditions: C.Surgical Procedure; Cardiac; Cardiac Dysrhythmia; Disorder of Pacing Function
• Intervention / Treatment: Device: Bridge Balloon

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 Type: Interventional
• Enrollment (Actual): 23
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33125
      • University of Miami Hospital
  • Massachusetts
    • Boston, Massachusetts, United States, 02118
      • Brigham and Women's Hospital
  • Minnesota
    • Saint Paul, Minnesota, United States, 55102
      • United Hospital
  • New Jersey
    • Camden, New Jersey, United States, 08103
      • Cooper University Health Care
  • North Carolina
    • Charlotte, North Carolina, United States, 28203
      • Sanger Heart & Vascular Institute Carolinas HealthCare System
    • Durham, North Carolina, United States, 27705
      • Duke University Medical Center
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Bridge Occlusion 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.

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.; Other Names: Bridge Occlusion Balloon, Spectranetics

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	33 minutes (average time)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time of Bridge Balloon Deployment	Time will be calculated in seconds starting from opening the Bridge Balloon Package up to full balloon deployment.	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.	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..	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..	1 year

Collaborators and Investigators

• Sponsor: Yale University
• Collaborators: Spectranetics Corporation
• Investigators: Principal Investigator: Jude Clancy, MD, Yale University

Study record dates

Study Major Dates

• Study Start: April 1, 2016
• Primary Completion (Actual): May 1, 2017
• Study Completion (Actual): October 1, 2017

Study Registration Dates

• First Submitted: March 4, 2016
• First Submitted That Met QC Criteria: March 15, 2016
• First Posted (Estimate): March 21, 2016

Study Record Updates

• Last Update Posted (Actual): June 14, 2021
• Last Update Submitted That Met QC Criteria: May 19, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: Lead extraction; Superior Vena Cava Tear; Pacemaker/Defibrillator lead extraction
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Cardiac Conduction System Disease
• Other Study ID Numbers: 1602017220

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO