Multicenter Imaging in Lead Extraction Study

Completed

• Conditions: Mechanical Complication of Cardiac Electronic Device

• Registration Number: NCT03772704
• Lead Sponsor: The Cleveland Clinic

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 leads through the SVC zone during lead extraction.

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 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 Timeline

• Study First Submitted: 2018-12-07
• Study First Submitted QC: 2018-12-10
• Study First Posted: 2018-12-11
• Study Start: 2018-12-13
• Status Verified: 2020-11
• Primary Completion: 2020-11-04
• Study Completion: 2020-11-04
• Last Update Submitted: 2020-11-17
• Last Update Posted: 2020-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• 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 Criteria

• Atrial fibrillation with uncontrolled rate

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Correlation of the presence and degree of fibrosis as determined by ECG gated cardiac CT with the presence and degree of fibrosis determined by ease of extraction sheath advancement	30 days	The presence and degree of fibrosis determined by the ease of extraction sheath advancement will be evaluated in three zones. Zone 1 will be the area before the Superior Vena Cava (SVC), Zone 2 in the SVC and Zone 3 after the SVC

Secondary Outcome Measures

Name	Time	Method
Major complications as defined by Heart Rhythm Society (HRS) 2017 consensus guidelines	30 days	major complications
Minor complications as defined by HRS 2017 consensus guidelines	30 days	minor complications
Percentage of ECG gated CT scans that show fibrosis	30 days	The percentage of ECG gated CT scans will be determined by scans that show little to no SVC (Zone 2) fibrosis, show little to no Zone 1 fibrosis, show little to no Zone 3 fibrosis, cardiac perforation, extravascular lead location
Procedural outcomes	30 days	Operator ease of extraction (grade 1-5)
Pathological reports from extracted leads	30 days	Pathology reports from extracted leads if available
Mortality	30 days	Death assessed
Fluoroscopy time	30 days	Fluoroscopy duration of time
Hospitalizations directly related to the extraction of leads or procedure related	30 days	Number of hospitalizations related to the extraction of leads or procedure related within 30 days post procedure

Trial Locations

Locations (5)

United Heart and Vascular Clinic; 🇺🇸 Saint Paul, Minnesota, United States

Northwell Health; 🇺🇸 Manhasset, New York, United States

Cleveland Clinic; 🇺🇸 Cleveland, Ohio, United States

Duke University; 🇺🇸 Durham, North Carolina, United States

Asklepios Klinik St. Georg; 🇩🇪 Hamburg, Germany