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.
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Percentage of Participants With Interventional Procedures Successfully Completed
Timeframe: From enrollment to the end of treatment at 12 months
Mean Pacing Threshold at 12-Month Follow-Up
Timeframe: 12-month follow-up visit
Fluoroscopy Time (Minutes) During Cardiac Device Implantation With or Without Remote Assistance
Timeframe: During the interventional procedure up to 2 hours
Electrophysiology Laboratory Occupancy
Timeframe: The time in minutes during procedure