Safety and Performance of LeadExx LC System in Lead Extraction
NCT02996929 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10
Last updated 2016-12-19
Summary
The study's main purpose is to evaluate the safety and performance of the LeadExx LC System and its ability to safely extract leads.
The study will enroll 10 patients scheduled for CIED lead extraction. The decision upon lead extraction will be based upon the applicable Heart Rhythm Society guidelines or European Heart Rhythm Association (EHRA).
Conditions
- Implant Site Infection
Interventions
- DEVICE
-
LC System
Subjects will undergo CIED lead extraction with the LC system
Sponsors & Collaborators
-
LeadExx Cardiac Ltd.
lead INDUSTRY
Principal Investigators
-
Eyal Nof, Dr. · Sheba Medical Center
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2017-02-28
- Primary Completion
- 2017-02-28
- Completion
- 2017-04-30
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