Multicenter Imaging in Lead Extraction Study (MILES)

NeuroTherapia, Inc.

Status: Completed

Conditions: Mechanical Complication of Cardiac Electronic Device

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT03772704

18-1480

Details and patient eligibility

About

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.

Full 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

Enrollment: 200 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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