Cardiac Dysrhythmia, C.Surgical Procedure; Cardiac, Disorder of Pacing Function
Conditions
Keywords
Lead extraction, Superior Vena Cava Tear, Pacemaker/Defibrillator lead extraction
Brief summary
To evaluate the use of an occlusion balloon (Bridge™ Occlusion Balloon, Spectranetics) within the Superior Vena Cava in lead extraction patients.
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.
Interventions
DEVICEBridge 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.
Sponsors
Spectranetics Corporation
Yale University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Successful Balloon Occlusion of Superior Vena Cava | 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
| Measure | Time frame | Description |
|---|---|---|
| Time of Bridge Balloon Deployment | 33 minutes (average time) | Time will be calculated in seconds starting from opening the Bridge Balloon Package up to full balloon deployment. |
| Number of Participants With Changes in Heart Rate at One Year | 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. |
| Number of Participants With Changes in Blood Pressure at One Year | 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.. |
| Number of Participants With Changes in SPO2 at One Year | 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.. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
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. | 23 |
| Total | 23 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 1 |
Baseline characteristics
| Characteristic | Bridge Occlusion Balloon |
|---|---|
| Age, Continuous | 61 years STANDARD_DEVIATION 15 |
| Comorbidities Congenital Heart Disease | 1 Participants |
| Comorbidities Coronary Artery Disease | 11 Participants |
| Comorbidities Diabetes Mellitus | 6 Participants |
| Creatinine | 1.05 mg/dL STANDARD_DEVIATION 0.29 |
| Ejection Fraction | 43 percent STANDARD_DEVIATION 15 |
| New York Heart Association Class I | 2 Participants |
| New York Heart Association Class II | 5 Participants |
| New York Heart Association Class III | 13 Participants |
| New York Heart Association Class IV | 3 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 23 Participants |
| Region of Enrollment United States | 23 participants |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 19 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 23 |
| other Total, other adverse events | 0 / 23 |
| serious Total, serious adverse events | 1 / 23 |
Outcome results
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.
Time frame: 33 minutes (average time)
Population: All patients.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Bridge Occlusion Balloon | Number of Participants With Successful Balloon Occlusion of Superior Vena Cava | First Balloon Deployment | 18 Participants |
| Bridge Occlusion Balloon | Number of Participants With Successful Balloon Occlusion of Superior Vena Cava | Reposition and Reinflation | 5 Participants |
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..
Time frame: 1 year
Population: All patients.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Bridge Occlusion Balloon | Number of Participants With Changes in Blood Pressure at One Year | Unacceptable Changes | 0 Participants |
| Bridge Occlusion Balloon | Number of Participants With Changes in Blood Pressure at One Year | No Unacceptable Changes | 23 Participants |
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.
Time frame: 1 year
Population: All patients.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Bridge Occlusion Balloon | Number of Participants With Changes in Heart Rate at One Year | Unacceptable Changes | 0 Participants |
| Bridge Occlusion Balloon | Number of Participants With Changes in Heart Rate at One Year | No Unacceptable Changes | 23 Participants |
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..
Time frame: 1 year
Population: All patients.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Bridge Occlusion Balloon | Number of Participants With Changes in SPO2 at One Year | Unacceptable Changes | 0 Participants |
| Bridge Occlusion Balloon | Number of Participants With Changes in SPO2 at One Year | No Unacceptable Changes | 23 Participants |
Secondary
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)
Population: All patients.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bridge Occlusion Balloon | Time of Bridge Balloon Deployment | 121 seconds | Standard Deviation 50 |