Intravascular Ultrasound (IVUS) Imaging During Transvenous Lead Extraction (ISEE)
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|ClinicalTrials.gov Identifier: NCT04055740|
Recruitment Status : Not yet recruiting
First Posted : August 14, 2019
Last Update Posted : August 14, 2019
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|
|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)|
|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|
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.
- IVUS Grades [ Time Frame: 6 hours ]Operators will be able to successfully grade the degree of intravascular lead adherence (ILA) seen using IVUS imaging.
- 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
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 ClinicalTrials.gov identifier (NCT number): NCT04055740
|Contact: Tiffany Hartfirstname.lastname@example.org|
|United States, Illinois|
|The University of Chicago|
|Chicago, Illinois, United States, 60637|
|Principal Investigator:||Hemal Nayak, MD||University of Chicago|