Intravascular Ultrasound (IVUS) Imaging During Transvenous Lead Extraction

NCT04055740 | Completed Results FDA Device

• 1 other identifier: IRB18-1600
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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.

Conditions

Device Malfunction; ICD; Pacemaker Lead Dysfunction

Keywords

CIED

Outcome Measures

Primary Outcomes (1)

• IVUS Grades

  Operators will be able to successfully grade the degree of intravascular lead adherence (ILA) seen using IVUS imaging. Using the following scale, grading of ILA in each zone of interest, based on relative motion of lead will be performed: i. Grade 1: Freely mobile, Rarely adjacent to vasculature ii. Grade 2: Restricted mobility, Frequently adjacent to vasculature iii. Grade 3: Immobile, Always adjacent to vasculature iv. Grade L, added to number: Lead-to-lead binding

  6 hours

Secondary Outcomes (1)

• Extraction Difficulty Metrics

  Through study completion, expected to be 6 months

Study Arms (1)

IVUS imaging

EXPERIMENTAL

IVUS imaging will be used each patient undergoing transvenous lead extraction to visualize ILA

Device: IVUS Imaging

Interventions

IVUS Imaging DEVICE

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.

IVUS imaging

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Chicago: lead

Study Sites (1)

The University of Chicago

Chicago, Illinois, 60637, United States

Location

Related Publications (19)

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  PMID: 23510021 BACKGROUND

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  PMID: 29784681 BACKGROUND

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  PMID: 18652009 BACKGROUND

• Sadek MM, Cooper JM, Frankel DS, Santangeli P, Epstein AE, Marchlinski FE, Schaller RD. Utility of intracardiac echocardiography during transvenous lead extraction. Heart Rhythm. 2017 Dec;14(12):1779-1785. doi: 10.1016/j.hrthm.2017.08.023. Epub 2017 Aug 24.

  PMID: 28843419 BACKGROUND

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  PMID: 27581130 BACKGROUND

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  PMID: 23713912 BACKGROUND

Results Point of Contact

• Title: Dr. Andrew Beaser
• Organization: University of Chicago

abeaser@bsd.uchicago.edu

(888) 824-0200

Study Officials

• Hemal Nayak, MD

  University of Chicago

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single cohort of patients undergoing transvenous lead extraction

Study Record Dates

• First Submitted: August 7, 2019
• First Posted: August 14, 2019
• Study Start: September 13, 2019
• Primary Completion: October 31, 2021
• Study Completion: October 31, 2021
• Last Updated: September 3, 2024
• Results First Posted: September 3, 2024

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)