Trial Outcomes & Findings for Bridge Occlusion Balloon in Lead Extraction Procedure (NCT NCT02714153)

Last Updated: 2021-06-14

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

23 participants

Primary outcome timeframe

33 minutes (average time)

Results posted on

2021-06-14

Participant Flow

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	23
Overall Study COMPLETED	22
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	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.
Overall Study Death	1

Baseline Characteristics

Bridge Occlusion Balloon in Lead Extraction Procedure

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Bridge Occlusion Balloon n=23 Participants 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.
Age, Continuous	61 years STANDARD_DEVIATION 15 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	19 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	23 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	23 participants n=5 Participants
Comorbidities Congenital Heart Disease	1 Participants n=5 Participants
Comorbidities Diabetes Mellitus	6 Participants n=5 Participants
Comorbidities Coronary Artery Disease	11 Participants n=5 Participants
New York Heart Association Class I	2 Participants n=5 Participants
New York Heart Association Class II	5 Participants n=5 Participants
New York Heart Association Class III	13 Participants n=5 Participants
New York Heart Association Class IV	3 Participants n=5 Participants
Ejection Fraction	43 percent STANDARD_DEVIATION 15 • n=5 Participants
Creatinine	1.05 mg/dL STANDARD_DEVIATION 0.29 • n=5 Participants

PRIMARY outcome

Timeframe: 33 minutes (average time)

Population: All patients.

Outcome measures

Outcome measures
Measure	Bridge Occlusion Balloon n=23 Participants 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.
Number of Participants With Successful Balloon Occlusion of Superior Vena Cava First Balloon Deployment	18 Participants
Number of Participants With Successful Balloon Occlusion of Superior Vena Cava Reposition and Reinflation	5 Participants

SECONDARY outcome

Timeframe: 33 minutes (average time)

Population: All patients.

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

Outcome measures

Outcome measures
Measure	Bridge Occlusion Balloon n=23 Participants 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.
Time of Bridge Balloon Deployment	121 seconds Standard Deviation 50

SECONDARY outcome

Timeframe: 1 year

Population: All patients.

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.

Outcome measures

Outcome measures
Measure	Bridge Occlusion Balloon n=23 Participants 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.
Number of Participants With Changes in Heart Rate at One Year Unacceptable Changes	0 Participants
Number of Participants With Changes in Heart Rate at One Year No Unacceptable Changes	23 Participants

SECONDARY outcome

Timeframe: 1 year

Population: All patients.

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..

Outcome measures

Outcome measures
Measure	Bridge Occlusion Balloon n=23 Participants 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.
Number of Participants With Changes in Blood Pressure at One Year Unacceptable Changes	0 Participants
Number of Participants With Changes in Blood Pressure at One Year No Unacceptable Changes	23 Participants

SECONDARY outcome

Timeframe: 1 year

Population: All patients.

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..

Outcome measures

Outcome measures
Measure	Bridge Occlusion Balloon n=23 Participants 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.
Number of Participants With Changes in SPO2 at One Year Unacceptable Changes	0 Participants
Number of Participants With Changes in SPO2 at One Year No Unacceptable Changes	23 Participants

Adverse Events

Bridge Occlusion Balloon

Serious events: 1 serious events

Other events: 0 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Bridge Occlusion Balloon n=23 participants at risk 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.
Vascular disorders SVC Tear	4.3% 1/23 • Number of events 1 • 1 year

Other adverse events

Adverse event data not reported

Additional Information

Jude Clancy, MD Associate Professor Term; Director, Lead Management Program

Yale School of Medicine

Phone: (203) 785-4126

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place