NCT04055740: ISEE

Intravascular Ultrasound (IVUS) Imaging During Transvenous Lead Extraction

Completed NA Results posted Last updated 3 September 2024

What this trial tests

NA trial testing IVUS Imaging in Device Malfunction in 31 participants. Completed in 31 October 2021.

Timeline

13 September 2019

Primary endpoint
31 October 2021

31 October 2021

Quick facts

Lead sponsor	University of Chicago
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	31
Start date	13 September 2019
Primary completion	31 October 2021
Estimated completion	31 October 2021
Sites	1 location across United States

Drugs / interventions tested

• IVUS Imaging

Conditions studied

• Device Malfunction — all drugs for Device Malfunction →
• ICD — all drugs for ICD →
• Pacemaker Lead Dysfunction — all drugs for Pacemaker Lead Dysfunction →

Sponsor

University of Chicago

Who can join

21 and older, any sex, with Device Malfunction or ICD. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

IVUS Grades Primary · 6 hours

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

Right sided devices Zone1/2

Group	Value	95% CI
IVUS Imaging	1.33	± 0.58

Right sided devices Zone 3

Group	Value	95% CI
IVUS Imaging	1	± 0

Left sided devices Zone 1

Group	Value	95% CI
IVUS Imaging	1.57	± 0.81

Left sided devices Zone 2

Group	Value	95% CI
IVUS Imaging	1.44	± 0.58

Left sided devices Zone 3

Group	Value	95% CI
IVUS Imaging	1.32	± 0.63

All devices, all zones

Group	Value	95% CI
IVUS Imaging	1.40	± 0.50

Extraction Difficulty Metrics Secondary · 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 Extraction difficulty was measured by correlating IVUS ILA grade to lead dwell time - the amount of time it took to extract the lead. Using the following scale, grading of ILA in each zone of interest, based on relative motion of lead was 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

Right sided devices

Group	Value	95% CI
IVUS Imaging	26.5	± 21.92

Left sided devices

Group	Value	95% CI
IVUS Imaging	34.91	± 36.94

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.