Bridge Occlusion Balloon in Lead Extraction Procedure

Yale University

Status: Completed

Conditions: C.Surgical Procedure; Cardiac; Disorder of Pacing Function; Cardiac Dysrhythmia

Treatments: Device: Bridge Balloon

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02714153

1602017220

Details and patient eligibility

About

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

Full 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.

Enrollment: 23 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Device Feasibility

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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23 participants in 1 patient group

Bridge Occlusion Balloon

Experimental group

Description:

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:

Device: Bridge Balloon