Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT04055740 · ClinicalTrials.gov registry record · NA
Intravascular Ultrasound (IVUS) Imaging During Transvenous Lead Extraction
A NA study, sponsored by University of Chicago.
- Completed
- Registry status
- NA
- Development phase
- 31
- Enrollment target
NCT04055740 is a NA study that has completed, run by University of Chicago. The registered enrollment target is 31 participants.
The verdict
NCT04055740, a NA study, has completed, sponsored by University of Chicago.
- COMPLETED
- Registry status
- NA
- Development phase
- 31 participants
- Enrollment target
Study 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.
Interventions
- DEVICE IVUS Imaging
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 31 participants |
| Start Date | 2019-09-13 |
| Est. Completion | 2021-10-31 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04055740
The ClinicalTrials.gov registry entry for NCT04055740 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 31 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Chicago, which has 796 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which IVUS Imaging is the first listed.
NCT04055740 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04055740 about?
NCT04055740 is a clinical study titled "Intravascular Ultrasound (IVUS) Imaging During Transvenous Lead Extraction". 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 (T...
What is the current status of trial NCT04055740?
This trial is currently completed. It is a NA study. The enrollment target is 31 participants. The study started on 2019-09-13. Estimated completion is 2021-10-31.
What interventions are being tested in trial NCT04055740?
The interventions under investigation include: IVUS Imaging (DEVICE).
Who is sponsoring clinical trial NCT04055740?
This trial is sponsored by University of Chicago, which has 796 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.