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Clinical Trial 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 leads through the SVC zone during lead extraction.


Clinical Trial 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 the five study centers. The objective of this study is to determine whether a correlation exists between fibrosis detected on ECG gated cardiac CT and the ease of lead extraction as measured by need for extraction energy. All patients will be followed for 30 days post-lead extraction to assess vital status and re-hospitalizations via phone call ;


Study Design


Related Conditions & MeSH terms

  • Mechanical Complication of Cardiac Electronic Device

NCT number NCT03772704
Study type Observational [Patient Registry]
Source The Cleveland Clinic
Contact
Status Completed
Phase
Start date December 13, 2018
Completion date November 4, 2020