Electronic Device Implantation Through Remote Guidance

Sponsor
University of Calabria
Study ID
NCT06404021
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Jun 1, 2022
Status verified
Jul 2025
Primary completion
Sep 30, 2023
Completion
Oct 30, 2024

Study Design

Enrollment
30 participants (actual)
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • Experimental: Interventional cardiology procedures with engineer in remote support
  • Active Comparator: Interventional cardiology procedures with engineer in the electrophysiology laboratory

Primary Outcome Measure

Percentage of Participants With Interventional Procedures Successfully Completed [ Time Frame: From enrollment to the end of treatment at 12 months ]

Related Studies