NCT Number: NCT03772704
Multicenter Imaging in Lead Extraction Study
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.
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Age range
18 year and older
Sex eligibility
All sexes
Study type
Observational
Primary location
Asklepios Klinik St. Georg, Hamburg, Germany
About this study
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
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Primary outcomes
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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
Time frame: 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 outcomes
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Percentage of ECG gated CT scans that show fibrosis
Time frame: 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
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Major complications as defined by Heart Rhythm Society (HRS) 2017 consensus guidelines
Time frame: 30 days
major complications
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Minor complications as defined by HRS 2017 consensus guidelines
Time frame: 30 days
minor complications
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Mortality
Time frame: 30 days
Death assessed
-
Procedural outcomes
Time frame: 30 days
Operator ease of extraction (grade 1-5)
-
Fluoroscopy time
Time frame: 30 days
Fluoroscopy duration of time
-
Pathological reports from extracted leads
Time frame: 30 days
Pathology reports from extracted leads if available
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Hospitalizations directly related to the extraction of leads or procedure related
Time frame: 30 days
Number of hospitalizations related to the extraction of leads or procedure related within 30 days post procedure
Sponsors and collaborators
Lead sponsor
The Cleveland Clinic
Other
Collaborators
- Philips Healthcare
Registry information
Acronym: MILES
Important dates
- Study start
- 2018
- Primary completion
- 2020
- Study completion
- 2020
- First posted
- Dec 11, 2018
- Registry last updated
- Nov 18, 2020
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.