NCT04055740

Intravascular Ultrasound (IVUS) Imaging During Transvenous Lead Extraction

Intravascular ultraSound (IVUS) Imaging During transvEnous Lead Extraction (ISEE)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: University of Chicago · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2019-09-13
• Primary completion: 2021-10-31
• Completion: 2021-10-31
• First posted: 2019-08-14
• Last updated: 2024-09-03
• Results posted: 2024-09-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study