Multicenter Imaging in Lead Extraction Study (MILES)

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.

Study Overview

• Status: Completed
• Conditions: Mechanical Complication of Cardiac Electronic Device

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 Type: Observational
• Enrollment (Actual): 200

Contacts and Locations

Study Locations

• Germany
  • Hamburg, Germany, 20099
    • Asklepios Klinik St. Georg
• United States
  • Minnesota
    • Saint Paul, Minnesota, United States, 55102
      • United Heart and Vascular Clinic
  • New York
    • Manhasset, New York, United States, 11030
      • Northwell Health
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Referred patients for CIED lead extraction

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of ECG gated CT scans that show fibrosis	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	30 days
Major complications as defined by Heart Rhythm Society (HRS) 2017 consensus guidelines	major complications	30 days
Minor complications as defined by HRS 2017 consensus guidelines	minor complications	30 days
Mortality	Death assessed	30 days
Procedural outcomes	Operator ease of extraction (grade 1-5)	30 days
Fluoroscopy time	Fluoroscopy duration of time	30 days
Pathological reports from extracted leads	Pathology reports from extracted leads if available	30 days
Hospitalizations directly related to the extraction of leads or procedure related	Number of hospitalizations related to the extraction of leads or procedure related within 30 days post procedure	30 days

Collaborators and Investigators

• Sponsor: The Cleveland Clinic
• Collaborators: Philips Healthcare
• Investigators: Principal Investigator: Bruce Wilkoff, MD, The Cleveland Clinic

Publications and helpful links

General Publications

• Patel D, Vatterott P, Piccini J, Epstein LM, Hakmi S, Syed I, Koweek LM, Bolen M, Schoenhagen P, Tarakji KG, Francis N, Shao M, Wilkoff BL. Prospective Evaluation of the Correlation Between Gated Cardiac Computed Tomography Detected Vascular Fibrosis and Ease of Transvenous Lead Extraction. Circ Arrhythm Electrophysiol. 2022 Nov;15(11):e010779. doi: 10.1161/CIRCEP.121.010779. Epub 2022 Oct 28.

Study record dates

Study Major Dates

• Study Start (Actual): December 13, 2018
• Primary Completion (Actual): November 4, 2020
• Study Completion (Actual): November 4, 2020

Study Registration Dates

• First Submitted: December 7, 2018
• First Submitted That Met QC Criteria: December 10, 2018
• First Posted (Actual): December 11, 2018

Study Record Updates

• Last Update Posted (Actual): November 18, 2020
• Last Update Submitted That Met QC Criteria: November 17, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: 18-1480

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No