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Completed

NCT Number: NCT02714153

Bridge Occlusion Balloon in Lead Extraction Procedure

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

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Key information

Conditions

C.Surgical Procedure; Cardiac Arrhythmias, Cardiac Cardiac Dysrhythmia Cardiovascular Diseases Disorder of Pacing Function Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Miami Hospital, Miami, Florida, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bridge Balloon

Device

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

Primary outcomes

  1. Number of Participants With Successful Balloon Occlusion of Superior Vena Cava

    Time frame: 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 outcomes

  1. Time of Bridge Balloon Deployment

    Time frame: 33 minutes (average time)

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

  2. Number of Participants With Changes in Heart Rate at One Year

    Time frame: 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.

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

    Time frame: 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..

  4. Number of Participants With Changes in SPO2 at One Year

    Time frame: 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..

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • Spectranetics Corporation

Registry information

Official study title

Bridge Occlusion Balloon Initial Use in Humans Study

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Mar 21, 2016
Registry last updated
Jun 14, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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