Trial Outcomes & Findings for Intravascular Ultrasound (IVUS) Imaging During Transvenous Lead Extraction (NCT NCT04055740)

Last Updated: 2024-09-03

Results Overview

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

Recruitment status

COMPLETED

Study phase

Target enrollment

31 participants

Primary outcome timeframe

6 hours

Results posted on

2024-09-03

Participant Flow

Enrollment closed across the study due to low enrollment.

Participant milestones

Participant milestones
Measure	IVUS Imaging IVUS imaging will be used each patient undergoing transvenous lead extraction to visualize ILA 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.
Overall Study STARTED	31
Overall Study COMPLETED	31
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

One patient had missing age.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	IVUS Imaging n=31 Participants IVUS imaging will be used each patient undergoing transvenous lead extraction to visualize ILA 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.
Age, Categorical <=18 years	0 Participants n=30 Participants • One patient had missing age.
Age, Categorical Between 18 and 65 years	18 Participants n=30 Participants • One patient had missing age.
Age, Categorical >=65 years	12 Participants n=30 Participants • One patient had missing age.
Age, Continuous	63.6 years STANDARD_DEVIATION 12.64 • n=30 Participants • One patient had missing age.
Sex: Female, Male Female	15 Participants n=30 Participants • One patient had missing sex.
Sex: Female, Male Male	15 Participants n=30 Participants • One patient had missing sex.
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=31 Participants
Race (NIH/OMB) Asian	0 Participants n=31 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=31 Participants
Race (NIH/OMB) Black or African American	17 Participants n=31 Participants
Race (NIH/OMB) White	12 Participants n=31 Participants
Race (NIH/OMB) More than one race	0 Participants n=31 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=31 Participants
Region of Enrollment United States	31 Participants n=31 Participants
Body mass index (BMI)	29.68 kg/m^2 STANDARD_DEVIATION 6.29 • n=29 Participants • 2 patients did not have data to determine BMI.
Height	170.2 cm STANDARD_DEVIATION 12.64 • n=30 Participants • One patient had missing height.

PRIMARY outcome

Timeframe: 6 hours

Population: 3 patients did not have any ILA grades.

Outcome measures

Outcome measures
Measure	IVUS Imaging n=28 Participants IVUS imaging will be used each patient undergoing transvenous lead extraction to visualize ILA 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 Right sided devices Zone1/2	1.33 Grade Standard Deviation 0.58
IVUS Grades Right sided devices Zone 3	1 Grade Standard Deviation 0
IVUS Grades Left sided devices Zone 1	1.57 Grade Standard Deviation 0.81
IVUS Grades Left sided devices Zone 2	1.44 Grade Standard Deviation 0.58
IVUS Grades Left sided devices Zone 3	1.32 Grade Standard Deviation 0.63
IVUS Grades All devices, all zones	1.40 Grade Standard Deviation 0.50

SECONDARY outcome

Timeframe: Through study completion, expected to be 6 months

Population: Means calculated for patients with left sided devices vs patients with right sided devices - 4 patients had missing data

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 number: Lead-to-lead binding

Outcome measures

Outcome measures
Measure	IVUS Imaging n=28 Participants IVUS imaging will be used each patient undergoing transvenous lead extraction to visualize ILA 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.
Extraction Difficulty Metrics Right sided devices	26.5 minutes Standard Deviation 21.92
Extraction Difficulty Metrics Left sided devices	34.91 minutes Standard Deviation 36.94

Adverse Events

IVUS Imaging

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Andrew Beaser

University of Chicago

Phone: (888) 824-0200

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place