Clinical Trials Logo
  1. Home
  2. ICD
  3. NCT04055740

Intravascular Ultrasound (IVUS) Imaging During Transvenous Lead Extraction — ISEE  

ICD Clinical Trial

Official title:
Intravascular ultraSound (IVUS) Imaging During transvEnous Lead Extraction (ISEE)

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04055740
Study type Interventional
Source University of Chicago
Contact
Status Completed
Phase N/A
Start date September 13, 2019
Completion date October 31, 2021
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT05048602 - Drug-induced Brugada Syndrome Research Database
Not yet recruiting NCT01430806 - Dronaderone to Prevent Recurrent Implantable Cardioverter Defibrillator (ICD) Shocks N/A
Completed NCT02877693 - A Post-market Clinical Evaluation of St. Jude Medical™ MR Conditional ICD System on Patients Undergoing Magnetic Resonance Imaging N/A
Completed NCT00890461 - Reconstruction of 12-Lead Electrogram From Intracardiac Signals From Defibrillators During or After Implantation N/A
Completed NCT03366181 - Anti Arrhythmic Therapies and Sudden Cardiac Deaths
Completed NCT02713360 - Screening and Intervention Reducing Anxiety in Patients With Implanted Cardioverter Defibrillator (ICD) N/A
Completed NCT06068699 - Postcards to Improve Remote Monitoring Adherence Among Veterans N/A
Completed NCT01594112 - Ability of Home Monitoring® to Detect and Manage the Inappropriate Diagnoses in Implantable Cardioverter Defibrillators. N/A
Recruiting NCT03357926 - Prospective Database for Prediction of Atrial Fibrillation in Pacemaker and ICD Patients
Active, not recruiting NCT04590144 - Safety and Performance of INVICTA Ventricular DF4 LEADS With Active Fixation-(APOLLO) N/A
Active, not recruiting NCT05361681 - EMI and CIED: Is High Power Charging of Battery Electric Car Safe? N/A
Active, not recruiting NCT04505007 - Guideline-Directed Medical Therapy in Patients After Implantation of Implantable Cardioverter Defibrillators to Improve Long-Term Outcomes N/A
Active, not recruiting NCT04981496 - Novel ICD Arrhythmia Detection Algorithm
Completed NCT04014946 - Assessment of Risk Factors for Appropriate ICD (Implantable Cardioverter-defibrillator) Intervention in Patients With Ischemic Cardiomyopathy N/A
Completed NCT02693262 - Comparing Rate Response With CLS Versus Accelerometer ICD Settings in Heart Failure Patients With BIOTRONIK CRT-Ds N/A
Recruiting NCT05072119 - Monaldi Hospital Rhythm Registry
Completed NCT00652522 - Atrial Fibrillation Management in Congestive Heart Failure With Ablation N/A
Recruiting NCT05835791 - END - VT Cohort Study
Active, not recruiting NCT04284800 - Myocardial Injury in Patients With Cardiac Implantable Electronic Devices Undergoing Defibrillation Threshold Testing
Withdrawn NCT04678128 - Dance4Healing: Explore the Benefits of Tele-Dance in Individuals With an Implantable Cardioverter-defibrillator (ICD) N/A