Multicenter Imaging in Lead Extraction Study (MILES)

• ClinicalTrials.gov Identifier: NCT03772704
• Recruitment Status: Completed
• First Posted: December 11, 2018
• Last Update Posted: November 18, 2020
• Sponsor: The Cleveland Clinic
• Collaborator: Philips Healthcare
• Information provided by (Responsible Party): The Cleveland Clinic

Study Description

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

Study Design

• 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

Groups and Cohorts

Outcome Measures

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

Eligibility Criteria

• 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

Contacts and Locations

Locations

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

Sponsors and Collaborators

The Cleveland Clinic

Philips Healthcare

Investigators

• Principal Investigator: Bruce Wilkoff, MD; The Cleveland Clinic

More Information

Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: The Cleveland Clinic
• ClinicalTrials.gov Identifier: NCT03772704
• Other Study ID Numbers: 18-1480
• First Posted: December 11, 2018
• 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