NCT06404021

Electronic Device Implantation Through Remote Guidance

Randomized Open-label Single-center Trial on Remote Assistance Implementing Certified Specialized Engineers During Interventional Cardiology Procedures

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: University of Calabria · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Telemedicine
• Heart Failure
• Defibrillators

Interventions

Type	Name	Description
OTHER	interventional cardiology procedures with proctoring system	Interventional procedures are performed by utilizing a monitoring platform that provides real-time support without engineer in the electrophysiology laboratory
OTHER	interventional cardiology procedures with engineer in the electrophysiology laboratory	Biomedical engineers supervise the performance of interventional cardiology procedures in the electrophysiology laboratory.

Timeline

• Start date: 2022-06-01
• Primary completion: 2023-09-30
• Completion: 2024-10-30
• First posted: 2024-05-08
• Last updated: 2025-07-20
• Results posted: 2025-07-20

Locations

1 site across 1 country: Italy