Multicenter Imaging in Lead Extraction Study (MILES)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03772704 |
Recruitment Status :
Completed
First Posted : December 11, 2018
Last Update Posted : November 18, 2020
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Condition or disease |
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Mechanical Complication of Cardiac Electronic Device |
Study Type : | Observational [Patient Registry] |
Actual Enrollment : | 200 participants |
Observational Model: | Case-Only |
Time Perspective: | Prospective |
Target Follow-Up Duration: | 30 Days |
Official Title: | Multicenter Imaging in Lead Extraction Study |
Actual Study Start Date : | December 13, 2018 |
Actual Primary Completion Date : | November 4, 2020 |
Actual Study Completion Date : | November 4, 2020 |
- 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
- 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
- Major complications as defined by Heart Rhythm Society (HRS) 2017 consensus guidelines [ Time Frame: 30 days ]major complications
- Minor complications as defined by HRS 2017 consensus guidelines [ Time Frame: 30 days ]minor complications
- 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
- 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

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03772704
United States, Minnesota | |
United Heart and Vascular Clinic | |
Saint Paul, Minnesota, United States, 55102 | |
United States, New York | |
Northwell Health | |
Manhasset, New York, United States, 11030 | |
United States, North Carolina | |
Duke University | |
Durham, North Carolina, United States, 27710 | |
United States, Ohio | |
Cleveland Clinic | |
Cleveland, Ohio, United States, 44195 | |
Germany | |
Asklepios Klinik St. Georg | |
Hamburg, Germany, 20099 |
Principal Investigator: | Bruce Wilkoff, MD | The Cleveland Clinic |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | The Cleveland Clinic |
ClinicalTrials.gov Identifier: | NCT03772704 |
Other Study ID Numbers: |
18-1480 |
First Posted: | December 11, 2018 Key Record Dates |
Last Update Posted: | November 18, 2020 |
Last Verified: | November 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |