N/A N=23 Device Feasibility

Bridge Occlusion Balloon in Lead Extraction Procedure

C.Surgical Procedure; Cardiac · Cardiac Dysrhythmia · Disorder of Pacing Function

Bottom Line

View on ClinicalTrials.gov: NCT02714153 ↗

Enrolled (actual)

Serious AEs

4.4%

Results posted

Apr 2021

Primary outcome: Primary: Number of Participants With Successful Balloon Occlusion of Superior Vena Cava — 18; 5 Participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Bridge Balloon (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Yale University
Primary completion: May 2017

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Successful Balloon Occlusion of Superior Vena Cava	18; 5	—
SECONDARY Time of Bridge Balloon Deployment	121	—
SECONDARY Number of Participants With Changes in Heart Rate at One Year	0; 23	—
SECONDARY Number of Participants With Changes in Blood Pressure at One Year	0; 23	—
SECONDARY Number of Participants With Changes in SPO2 at One Year	0; 23	—

Summary

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

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02714153). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.