NCT02996929

Brief 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).

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2017

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 11, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 19, 2016

Completed
1 month until next milestone

Study Start

First participant enrolled

February 1, 2017

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2017

Completed
Last Updated

December 19, 2016

Status Verified

December 1, 2016

Enrollment Period

Same day

First QC Date

December 11, 2016

Last Update Submit

December 14, 2016

Conditions

Implant Site Infection

Outcome Measures

Primary Outcomes (1)

  • Adverse events

    Monitoring Adverse events that are related to the extraction procedure, or the extraction system

    1 month

Secondary Outcomes (2)

  • Performance

    During procedure

  • Practical removal of intact lead

    During procedure

Study Arms (1)

Study group

EXPERIMENTAL

Subjects who are scheduled for CIED lead extraction with the LC system

Device: LC System

Interventions

LC SystemDEVICE

Subjects will undergo CIED lead extraction with the LC system

Study group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female 18-75 years old.
  • Scheduled for an CIED lead extraction upon current guidelines
  • Willing and able to sign the informed consent.
  • Lead implant duration more than 1 year and less than 5 years.
  • Patient with Lead size 7F
  • BMI 22-32
  • Number of implanted leads 1-3

You may not qualify if:

  • Lead implant duration is less than 1 year or more than 5 years.
  • Patients with acute and chronic lead infections
  • Pericardial or subcutaneous CIED systems (without trans venous CIED lead)
  • Pregnant or lactating.
  • Patients with expected survival of less than 1 year.
  • Subjects who are participating in another clinical study.
  • Subjects who are unable or unwilling to follow the study schedule of visits.
  • Contraindication to administration of iodinated contrast (creatinine \> 2.0 or contrast allergy)
  • Patients with a history of venous thromboembolism, coagulopathy or malignancy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Eyal Nof, Dr.

    Sheba Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Eyal Nof, Dr.

CONTACT

972-3-530-3810Eyal.Nof@sheba.health.gov.il

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 11, 2016

First Posted

December 19, 2016

Study Start

February 1, 2017

Primary Completion

February 1, 2017

Study Completion

April 1, 2017

Last Updated

December 19, 2016

Record last verified: 2016-12

Data Sharing

IPD Sharing
Will not share