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Bridge Occlusion Balloon for Cardiac Surgery

N/A

Waitlist Available

Led By Jude Clancy, MD

Research Sponsored by Yale University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

No Placebo-Only Group

Summary

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

Eligible Conditions

Arrhythmia
Cardiac Surgery

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of Participants With Successful Balloon Occlusion of Superior Vena Cava

Secondary study objectives

Number of Participants With Changes in Blood Pressure at One Year

Number of Participants With Changes in Heart Rate at One Year

Number of Participants With Changes in SPO2 at One Year

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Bridge Occlusion BalloonExperimental Treatment1 Intervention

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Bridge Balloon

2016

N/A

~30

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