At a glance
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Randomized Open-label Single-center Trial on Remote Assistance Implementing Certified Specialized Engineers During Interventional Cardiology Procedures
In Brief
A clinical study evaluating interventional cardiology procedures with proctoring system and interventional cardiology procedures with engineer in the electrophysiology laboratory for Telemedicine and 2 related conditions. Completed, enrolled 30 participants across 1 site.
Detailed Summary
Implantable cardioverter defibrillators (ICD) and cardiac resynchronization therapy defibrillator (CRT-D) implants are limited by availability and costs of field clinical specialist (FCS) bioengineers. This study explores feasibility of remotely supported implantations through an internet based platform, aiming at enhancing efficiency and overcoming geographical or pandemic related barriers. The first phase of the study included programming and phantom assessments in 20 cases followed by 10 remote guided CRT-D and ICD implantations in additional heart failure patients, compared to 20 procedures with FCS on site. Data analysis revealed no significant differences in acute outcomes or electronic parameters at one year follow-up compared to on-site FCS. Finally, this study demonstrates the safety after testing at one year of follow-up.
Study Details
Timeline
Interventions
Interventional procedures are performed by utilizing a monitoring platform that provides real-time support without engineer in the electrophysiology laboratory
Biomedical engineers supervise the performance of interventional cardiology procedures in the electrophysiology laboratory.