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Multicenter Imaging in Lead Extraction Study

NCT ID: NCT03772704

Last Updated: 2020-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-12-13

Study Completion Date

2020-11-04

Brief Summary

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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

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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

Conditions

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Mechanical Complication of Cardiac Electronic Device

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Philips Healthcare

INDUSTRY

Sponsor Role collaborator

The Cleveland Clinic

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bruce Wilkoff, MD

Role: PRINCIPAL_INVESTIGATOR

The Cleveland Clinic

Locations

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United Heart and Vascular Clinic

Saint Paul, Minnesota, United States

Site Status

Northwell Health

Manhasset, New York, United States

Site Status

Duke University

Durham, North Carolina, United States

Site Status

Cleveland Clinic

Cleveland, Ohio, United States

Site Status

Asklepios Klinik St. Georg

Hamburg, , Germany

Site Status

Countries

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United States Germany

References

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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.

Reference Type DERIVED
PMID: 36306341 (View on PubMed)

Other Identifiers

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18-1480

Identifier Type: -

Identifier Source: org_study_id