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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04055740
Recruitment Status : Not yet recruiting
First Posted : August 14, 2019
Last Update Posted : August 14, 2019
Information provided by (Responsible Party):
Hemal Nayak, University of Chicago

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 Malfunction ICD Pacemaker Lead Dysfunction Device: IVUS Imaging Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Single 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)
Estimated Study Start Date : September 2019
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

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.

Primary Outcome Measures :
  1. IVUS Grades [ Time Frame: 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 [ 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

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04055740

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Contact: Tiffany Hart 773-702-0535

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United States, Illinois
The University of Chicago
Chicago, Illinois, United States, 60637
Sponsors and Collaborators
University of Chicago
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Principal Investigator: Hemal Nayak, MD University of Chicago


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Responsible Party: Hemal Nayak, Associate Professor of Medicine, University of Chicago Identifier: NCT04055740     History of Changes
Other Study ID Numbers: IRB18-1600
First Posted: August 14, 2019    Key Record Dates
Last Update Posted: August 14, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Hemal Nayak, University of Chicago: