Multicenter Imaging in Lead Extraction Study

Mechanical Complication of Cardiac Electronic Device Clinical Trial

— MILES  

Official title:

Multicenter Imaging in Lead Extraction Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03772704
• Other study ID #: 18-1480
• Status: Completed
• Start date: December 13, 2018
• Est. completion date: November 4, 2020

Study information

• Verified date: November 2020
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: November 4, 2020
• Est. primary completion date: November 4, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Mechanical Complication of Cardiac Electronic Device

Locations

Country	Name	City	State
Germany	Asklepios Klinik St. Georg	Hamburg
United States	Cleveland Clinic	Cleveland	Ohio
United States	Duke University	Durham	North Carolina
United States	Northwell Health	Manhasset	New York
United States	United Heart and Vascular Clinic	Saint Paul	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
The Cleveland Clinic	Philips Healthcare

Countries where clinical trial is conducted

United States,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Major complications as defined by Heart Rhythm Society (HRS) 2017 consensus guidelines	major complications	30 days
Secondary	Minor complications as defined by HRS 2017 consensus guidelines	minor complications	30 days
Secondary	Mortality	Death assessed	30 days
Secondary	Procedural outcomes	Operator ease of extraction (grade 1-5)	30 days
Secondary	Fluoroscopy time	Fluoroscopy duration of time	30 days
Secondary	Pathological reports from extracted leads	Pathology reports from extracted leads if available	30 days
Secondary	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