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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02714153
Other study ID # 1602017220
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 2016
Est. completion date October 2017

Study information

Verified date May 2021
Source Yale University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 23
Est. completion date October 2017
Est. primary completion date May 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years to 85 Years
Eligibility 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 Design


Intervention

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.

Locations

Country Name City State
United States Brigham and Women's Hospital Boston Massachusetts
United States Cooper University Health Care Camden New Jersey
United States Sanger Heart & Vascular Institute Carolinas HealthCare System Charlotte North Carolina
United States Cleveland Clinic Cleveland Ohio
United States Duke University Medical Center Durham North Carolina
United States University of Miami Hospital Miami Florida
United States United Hospital Saint Paul Minnesota

Sponsors (2)

Lead Sponsor Collaborator
Yale University Spectranetics Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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)
Secondary 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
Secondary 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
Secondary 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
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