An interventional study of Bridge Balloon in C.Surgical Procedure; Cardiac, Cardiac Dysrhythmia and Disorder of Pacing Function, sponsored by Yale University. Completed at 7 sites in United States. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2021-06-14.
Sponsored by Yale University · Not applicable, Interventional, and Device feasibility
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.
885 studies on the registry are indexed under Arrhythmias, Cardiac; 235 are open to participants now.
This study's enrollment of 23 is below the median of 99 across 429 interventional studies indexed under Arrhythmias, Cardiac.
Browse Arrhythmias, Cardiac studies →Yale University is the lead sponsor of 1,724 studies on the registry; 298 are open to participants now.
Of its 210 completed or terminated interventional studies of FDA-regulated products, 126 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Lead extraction patients with:
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.
Also known as: Bridge Occlusion Balloon, Spectranetics
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)
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..
Time frame: 1 year
| Milestone | Bridge Occlusion Balloon |
|---|---|
| Started | 23 |
| Completed | 22 |
| Not completed | 1 |
| Withdrew: Death | 1 |
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.
| Participants | Bridge Occlusion Balloon |
|---|---|
| First Balloon Deployment | 18 |
| Reposition and Reinflation | 5 |
Time will be calculated in seconds starting from opening the Bridge Balloon Package up to full balloon deployment.
| seconds | Bridge Occlusion Balloon |
|---|---|
| Time of Bridge Balloon Deployment | 121 ± 50 |
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.
| Participants | Bridge Occlusion Balloon |
|---|---|
| Unacceptable Changes | 0 |
| No Unacceptable Changes | 23 |
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..
| Participants | Bridge Occlusion Balloon |
|---|---|
| Unacceptable Changes | 0 |
| No Unacceptable Changes | 23 |
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..
| Participants | Bridge Occlusion Balloon |
|---|---|
| Unacceptable Changes | 0 |
| No Unacceptable Changes | 23 |
Collected over 1 year. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Bridge Occlusion Balloon | 1/23 (4.3%) | 1/23 (4.3%) | 0/23 (0%) |
| Event | Bridge Occlusion Balloon |
|---|---|
| SVC TearVascular disorders | 1/23 |
| Age, Continuous(years) | Bridge Occlusion Balloon |
|---|---|
| Mean | 61 ± 15 |
| Sex: Female, Male(Participants) | Bridge Occlusion Balloon |
|---|---|
| Female | 4 |
| Male | 19 |
| Race (NIH/OMB)(Participants) | Bridge Occlusion Balloon |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 23 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | Bridge Occlusion Balloon |
|---|---|
| United States | 23 |
| Comorbidities(Participants) | Bridge Occlusion Balloon |
|---|---|
| Congenital Heart Disease | 1 |
| Diabetes Mellitus | 6 |
| Coronary Artery Disease | 11 |
| New York Heart Association Class(Participants) | Bridge Occlusion Balloon |
|---|---|
| I | 2 |
| II | 5 |
| III | 13 |
| IV | 3 |
| Ejection Fraction(percent) | Bridge Occlusion Balloon |
|---|---|
| Mean | 43 ± 15 |
| Creatinine(mg/dL) | Bridge Occlusion Balloon |
|---|---|
| Mean | 1.05 ± 0.29 |
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Yale University