Multicenter Imaging in Lead Extraction Study
| Status: | Recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 12/15/2018 |
| Start Date: | December 13, 2018 |
| End Date: | December 31, 2019 |
| Contact: | Ruth Cannata |
| Email: | cannatr@ccf.org |
| Phone: | 216-445-7839 |
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.
on Electrocardiogram (ECG) gated Computed Tomography (CT) scans with ease of advancing
sheaths over the leads through the SVC zone during lead extraction.
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
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
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
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