Intravascular Ultrasound (IVUS) Imaging During Transvenous Lead Extraction (ISEE)

December 23, 2021 updated by: University of Chicago

Intravascular ultraSound (IVUS) Imaging During transvEnous Lead Extraction (ISEE)

The purpose of this study is to prospectively evaluate intravascular ultrasound (IVUS) imaging as a tool for grading the presence and characterization of intravascular lead adherence (ILA, or scarring) to cardiovascular implantable electronic device (CIED) leads during transvenous lead extraction (TLE) procedures in a multi-center study. IVUS should identify the location and severity of these adhesions, which the investigators will then correlate to difficulty of the extraction procedure using metrics like pulses of laser energy delivered and time required to traverse an area of fibrosis or ILA. The investigators will be focusing primarily on the section from innominate vein (INNV) down through the superior vena cava (SVC) to the right atrium.

Using IVUS to view blood vessels and the heart structure is approved by the Food and Drug Administration (FDA). Using it as described in this study is off label because of the manner in which it is advanced to the SVC, through the right atrium. While it is not restricted from use in this way, it is not specifically on-label. It should be noted that the use of IVUS during TLE procedures as proposed in this study is routine at the University of Chicago and patients will undergo this procedure regardless of participation in this study. The EP physician team regards the use of IVUS during TLE to be nonsignificant risk.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

28

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60637
        • The University of Chicago

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients at least 21 years of age
  • Patients with at least one lead over 1 year dwell time requiring extraction

Exclusion Criteria:

  • Inability of patient capacity to provide consent for themselves either due to medical or psychiatric comorbidity
  • Venous occlusion to the extent that the IVUS catheter cannot pass
  • Leads < 1 year dwell time requiring extraction

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: IVUS imaging
IVUS imaging will be used each patient undergoing transvenous lead extraction to visualize ILA
Device: IVUS Imaging
IVUS or radial-ICE (intracardiac echocardiography) is a visualization tool used in many cardiac procedures including electrophysiology procedures (catheter ablation). Its utility in identifying ILA will be assessed in this study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
IVUS Grades
Time Frame: 6 hours
Operators will be able to successfully grade the degree of intravascular lead adherence (ILA) seen using IVUS imaging.
6 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Extraction Difficulty Metrics
Time Frame: Through study completion, expected to be 6 months
Operators will record the energy and time necessary to traverse binding sites and will be able to correlate these two metrics to IVUS ILA grade
Through study completion, expected to be 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Chicago

Investigators

  • Principal Investigator: Hemal Nayak, MD, University of Chicago

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 13, 2019

Primary Completion (ACTUAL)

October 31, 2021

Study Completion (ACTUAL)

October 31, 2021

Study Registration Dates

First Submitted

August 7, 2019

First Submitted That Met QC Criteria

August 12, 2019

First Posted (ACTUAL)

August 14, 2019

Study Record Updates

Last Update Posted (ACTUAL)

December 27, 2021

Last Update Submitted That Met QC Criteria

December 23, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • IRB18-1600

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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