Electronic Device Implantation Through Remote Guidance

University of Calabria

Status: Completed

Conditions: Defibrillators; Heart Failure; Telemedicine

Treatments: Other: interventional cardiology procedures with proctoring system; Other: interventional cardiology procedures with engineer in the electrophysiology laboratory

Study type: Interventional

Funder types: Other

Identifiers

NCT06404021

#224

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients over 18 years
• Patients under 85 years
• Patients already implanted with defibrillator and admitted to cardiology division for others invasive procedures
• Patients undergoing defibrillator or cardiac resynchronization therapy defibrillator implantation
• Patients who signed written informed consent

Exclusion criteria

• Pacemaker dependent patients
• Patients who underwent generator replacement procedures

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Interventional cardiology procedures with engineer in remote support

Experimental group

Treatment:

Other: interventional cardiology procedures with proctoring system

Interventional cardiology procedures with engineer in the electrophysiology laboratory

Active Comparator group

Treatment:

Other: interventional cardiology procedures with engineer in the electrophysiology laboratory