Fluoroless Conduction System Pacing Utilizing Electro-Anatomic Mapping Versus Conventional Implantation: The Fluoroless- CSP Trial
Status: Completed
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
The goal of this study is to assess the feasibility, accuracy and safety of performing fluoroless (or low fluoro) conduction system pacing utilizing electro-anatomic mapping (EAM) with the CARTO 3 mapping system (Biosense Webster Inc, Irvine, CA) in comparison to a group of patients undergoing conventional conduction system pacing (CSP) Implants.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Age \> 18 years
• Indication for Permanent Pacemaker implantation or implantation of Cardiac Resynchronization Therapy Device
Locations
United States
Illinois
Rush University Medical Center
Chicago
Time Frame
Start Date: 2020-10-26
Completion Date: 2024-09-30
Participants
Target number of participants: 2
Treatments
Placebo_comparator: Conventional Conduction System Pacing(CSP) using fluoroscopy
Subjects in this arm will receive Conduction System Pacing(CSP) using conventional fluoroscopy technique.
Experimental: Fluoroless Conduction System Pacing(CSP) utilizing EAM with the CARTO 3 mapping system
Subjects in this arm will receive Conduction System Pacing(CSP) utilizing electroanatomic mapping system to eliminate or minimize fluoroscopic exposure.
Related Therapeutic Areas
Sponsors
Leads: Rush University Medical Center