Status:

COMPLETED

Multicenter Imaging in Lead Extraction Study

Lead Sponsor:

The Cleveland Clinic

Collaborating Sponsors:

Philips Healthcare

Conditions:

Mechanical Complication of Cardiac Electronic Device

Eligibility:

All Genders

18+ years

Brief Summary

The primary objectives of this registry is to correlate the amount of fibrosis as documented on Electrocardiogram (ECG) gated Computed Tomography (CT) scans with ease of advancing sheaths over the lea...

Detailed Description

This is a multi-center, prospective, observational registry study which plans to enroll approximately 200 patients referred for Cardiac Implantable Electronic Device(CIED) lead extraction at one of th...

Eligibility Criteria

Inclusion

  • Referred for CIED (Cardiac Implantable Electronic Device) lead extraction with at least 1 lead with dwell time greater than one year
  • ≥ 18 years of age
  • Appropriate candidate for chest/cardiac CT with contrast and full lead analysis

Exclusion

  • Atrial fibrillation with uncontrolled rate

Key Trial Info

Start Date :

December 13 2018

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

November 4 2020

Estimated Enrollment :

200 Patients enrolled

Trial Details

Trial ID

NCT03772704

Start Date

December 13 2018

End Date

November 4 2020

Last Update

November 18 2020

Active Locations (5)

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Page 1 of 2 (5 locations)

1

United Heart and Vascular Clinic

Saint Paul, Minnesota, United States, 55102

2

Northwell Health

Manhasset, New York, United States, 11030

3

Duke University

Durham, North Carolina, United States, 27710

4

Cleveland Clinic

Cleveland, Ohio, United States, 44195