The efficacy of PlasmaBlade in patients with cardiac implantable elctronic device, requiring capsulectomy

Comparison of efficacy and safety of PlasmaBlade and conventional electrosurgery in patients with cardiac implantable electronic device, requiring capsulectomy.

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0002243

Enrollment

200

Registered

2017-02-23

Start date

2016-06-16

Completion date

Unknown

Last updated

2019-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Medical Device : Patients will be randomized to PlasmaBlade group and Bovie Knife group in 1:1 fashion The PlasmaBlade group will use the Peak PlasmaBlade for electronic cauterization during the ge

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Age>= 19 Patients with cardiac implantable electronic device that is within the elective replacement interval

Exclusion criteria

Exclusion criteria: - Previous cardiac implantable electronic device infection history - Poor general condiction, not suitable for partcipation of study

Design outcomes

Primary

Measure	Time frame
Device related infection;All device related complication (hematoma, lead injury etc)	—

Secondary

Measure	Time frame
Procedure time, result of bacterial swab culture	—

Countries

Korea, Republic of

Contacts

Public ContactJi Hyun Lee

Asan Medical Center

89family@hanmail.net+82-2-3010-3164

Outcome results