Clinical trial NCT02714153: Bridge Occlusion Balloon in Lead Extraction Procedure
Official title: Bridge Occlusion Balloon Initial Use in Humans Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: C.Surgical Procedure; Cardiac
Cardiac Dysrhythmia
Disorder of Pacing Function
Keywords: Lead extraction
Superior Vena Cava Tear
Pacemaker/Defibrillator lead extraction
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: Spectranetics Corporation
First posted: 2016-03-21
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants With Successful Balloon Occlusion of Superior Vena Cava
timeFrame: 33 minutes (average time)
Secondary outcomes:
measure: Time of Bridge Balloon Deployment
timeFrame: 33 minutes (average time)
measure: Number of Participants With Changes in Heart Rate at One Year
timeFrame: 1 year
measure: Number of Participants With Changes in Blood Pressure at One Year
timeFrame: 1 year
measure: Number of Participants With Changes in SPO2 at One Year
timeFrame: 1 year
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami Hospital
state: Florida
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Saint Paul
country: United States
facility: United Hospital
state: Minnesota
city: Camden
country: United States
facility: Cooper University Health Care
state: New Jersey
city: Charlotte
country: United States
facility: Sanger Heart & Vascular Institute Carolinas HealthCare System
state: North Carolina
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
Study officials:
affiliation: Yale University
name: Jude Clancy, MD
role: PRINCIPAL_INVESTIGATOR
References: