Mechanical Complication of Cardiac Electronic Device
Conditions
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
Interventions
None listed
Sponsors
Philips Healthcare
The Cleveland Clinic
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| Major complications as defined by Heart Rhythm Society (HRS) 2017 consensus guidelines | 30 days | major complications |
| Minor complications as defined by HRS 2017 consensus guidelines | 30 days | minor complications |
| Mortality | 30 days | Death assessed |
| Percentage of ECG gated CT scans that show fibrosis | 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 |
| Fluoroscopy time | 30 days | Fluoroscopy duration of time |
| Pathological reports from extracted leads | 30 days | Pathology reports from extracted leads if available |
| Hospitalizations directly related to the extraction of leads or procedure related | 30 days | Number of hospitalizations related to the extraction of leads or procedure related within 30 days post procedure |
| Procedural outcomes | 30 days | Operator ease of extraction (grade 1-5) |
Countries
Germany, United States
Outcome results
None listed