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Multicenter Imaging in Lead Extraction Study (MILES)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03772704
Recruitment Status : Recruiting
First Posted : December 11, 2018
Last Update Posted : September 18, 2019
Sponsor:
Collaborator:
Philips Healthcare
Information provided by (Responsible Party):
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.

Condition or disease
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

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Study Type : Observational [Patient Registry]
Estimated 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
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019



Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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

  2. Major complications as defined by Heart Rhythm Society (HRS) 2017 consensus guidelines [ Time Frame: 30 days ]
    major complications

  3. Minor complications as defined by HRS 2017 consensus guidelines [ Time Frame: 30 days ]
    minor complications

  4. Mortality [ Time Frame: 30 days ]
    Death assessed

  5. Procedural outcomes [ Time Frame: 30 days ]
    Operator ease of extraction (grade 1-5)

  6. Fluoroscopy time [ Time Frame: 30 days ]
    Fluoroscopy duration of time

  7. Pathological reports from extracted leads [ Time Frame: 30 days ]
    Pathology reports from extracted leads if available

  8. 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
Study Population
Referred patients for CIED lead extraction
Criteria

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

Information from the National Library of Medicine

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


Contacts
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Contact: Ruth Cannata 216-445-7839 cannatr@ccf.org

Locations
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United States, Minnesota
United Heart and Vascular Clinic Recruiting
Saint Paul, Minnesota, United States, 55102
Contact: Pierce Vatterott, M.D.    651-241-2819    Pierce.vatterott@allina.com   
United States, New York
Northwell Health Recruiting
Manhasset, New York, United States, 11030
Contact: Laurence Epstein, MD    516-562-4100    lepstein@northwell.edu   
United States, North Carolina
Duke University Recruiting
Durham, North Carolina, United States, 27710
Contact: Jonathan Piccini, MD    919-681-8983    Jonathan.piccini@duke.edu   
United States, Ohio
Cleveland Clinic Recruiting
Cleveland, Ohio, United States, 44195
Contact: Bruce Wilkoff, MD    216-444-4975    WILKOFB@ccf.org   
Sponsors and Collaborators
The Cleveland Clinic
Philips Healthcare
Investigators
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Principal Investigator: Bruce Wilkoff, MD The Cleveland Clinic
Additional Information:

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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: September 18, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No