N/A
Completed N=23
Bridge Occlusion Balloon in Lead Extraction Procedure
C.Surgical Procedure; Cardiac · Cardiac Dysrhythmia · Disorder of Pacing Function
Source: ClinicalTrials.gov NCT02714153 ↗
Enrolled (actual)
23
Serious AEs
4.4%
Results posted
Apr 2021
Primary outcomePrimary: Number of Participants With Successful Balloon Occlusion of Superior Vena Cava — 18; 5 Participants
Summary
To evaluate the use of an occlusion balloon (Bridge™ Occlusion Balloon, Spectranetics) within the Superior Vena Cava in lead extraction patients.
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 | — |
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
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. Informational only — not medical advice.