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

Sponsor
University of Chicago (Other)
Overall Status
Completed
CT.gov ID
NCT04055740
Collaborator
(none)
28
Enrollment
1
Location
1
Arm
25.6
Actual Duration (Months)
1.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Device: IVUS Imaging
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
28 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
Single cohort of patients undergoing transvenous lead extractionSingle cohort of patients undergoing transvenous lead extraction
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Intravascular ultraSound (IVUS) Imaging During transvEnous Lead Extraction (ISEE)
Actual Study Start Date :
Sep 13, 2019
Actual Primary Completion Date :
Oct 31, 2021
Actual Study Completion Date :
Oct 31, 2021

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. IVUS Grades [6 hours]

    Operators will be able to successfully grade the degree of intravascular lead adherence (ILA) seen using IVUS imaging.

Secondary Outcome Measures

  1. Extraction Difficulty Metrics [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
21 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 The University of Chicago Chicago Illinois United States 60637

Sponsors and Collaborators

  • University of Chicago

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
University of Chicago
ClinicalTrials.gov Identifier:
NCT04055740
Other Study ID Numbers:
  • IRB18-1600
First Posted:
Aug 14, 2019
Last Update Posted:
Dec 27, 2021
Last Verified:
Dec 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
Keywords provided by University of Chicago
CIED

Study Results

No Results Posted as of Dec 27, 2021