Clinical trial NCT03772704: Multicenter Imaging in Lead Extraction Study
Official title: Multicenter Imaging in Lead Extraction Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mechanical Complication of Cardiac Electronic Device
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
Collaborators: name: Philips Healthcare
First posted: 2018-12-11
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Referred patients for CIED lead extraction

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.

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

Eligibility 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

Primary outcomes:
measure: 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
timeFrame: 30 days
Secondary outcomes:
measure: Percentage of ECG gated CT scans that show fibrosis
timeFrame: 30 days
measure: Major complications as defined by Heart Rhythm Society (HRS) 2017 consensus guidelines
timeFrame: 30 days
measure: Minor complications as defined by HRS 2017 consensus guidelines
timeFrame: 30 days
measure: Mortality
timeFrame: 30 days
measure: Procedural outcomes
timeFrame: 30 days
measure: Fluoroscopy time
timeFrame: 30 days
measure: Pathological reports from extracted leads
timeFrame: 30 days
measure: Hospitalizations directly related to the extraction of leads or procedure related
timeFrame: 30 days
Other outcomes:
Locations:
city: Saint Paul
country: United States
facility: United Heart and Vascular Clinic
state: Minnesota
city: Manhasset
country: United States
facility: Northwell Health
state: New York
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Hamburg
country: Germany
facility: Asklepios Klinik St. Georg
Study officials:
affiliation: The Cleveland Clinic
name: Bruce Wilkoff, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.