Electronic Device Implantation Through Remote Guidance

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

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 Overview

• Status: Completed
• Conditions: Heart Failure; Telemedicine; Defibrillators
• Intervention / Treatment: Other: interventional cardiology procedures with proctoring system; Other: interventional cardiology procedures with engineer in the electrophysiology laboratory

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Catanzaro, Italy, 88100
    • "Magna Graecia" University of Catanzaro

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Interventional cardiology procedures with engineer in remote support	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
Active Comparator: Interventional cardiology procedures with 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Interventional Procedures Successfully Completed	Investigators are going demonstrate the feasibility of cardiology interventional procedures using a proctoring system, comparing them to on site operations carried out by a biomedical engineer. For this purpose engineers develop a system for remote technical support with dedicated computer room, multimedia information system and multi angles cameras, located at the boarders of the electrophysiology lab. In the preclinical step phantom are used for approaching all types of materials and equipment that are going to be used in interventional procedures. Each procedure is considered complete and feasible when the measurements of the electronic parameters of all implanted leads are optimal, in particular, when the pacing function was effective (pacing threshold less than 1 Volt @ 0.5 millisecond).	From enrollment to the end of treatment at 12 months
Mean Pacing Threshold at 12-Month Follow-Up	The outcome assesses the mean pacing threshold at 12-month follow-up, used as an indicator of long-term electrical stability of implanted cardiac leads. Stable pacing thresholds suggest proper lead function and adequate myocardial contact over time.	12-month follow-up visit
Fluoroscopy Time (Minutes) During Cardiac Device Implantation With or Without Remote Assistance	Fluoroscopy time (FT), expressed in minutes, is used as a surrogate measure of procedural efficiency and radiation exposure. The FT corresponds to the skin-to-skin time and is recorded from the beginning of X-ray emission to the end of the cardiac device implantation procedure. Data are compared between two groups: procedures performed with onsite presence of the biomedical engineer and those executed with remote technical assistance through the telemedicine support system.	During the interventional procedure up to 2 hours
Electrophysiology Laboratory Occupancy	Investigators determined the duration of interventional procedures in minutes and compared this result both for standard and telemedicine driven approach.	The time in minutes during procedure

Collaborators and Investigators

• Sponsor: University of Calabria
• Investigators: Principal Investigator: Antonio Curcio, University of Calabria

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2022
• Primary Completion (Actual): September 30, 2023
• Study Completion (Actual): October 30, 2024

Study Registration Dates

• First Submitted: April 26, 2024
• First Submitted That Met QC Criteria: May 4, 2024
• First Posted (Actual): May 8, 2024

Study Record Updates

• Last Update Posted (Actual): July 20, 2025
• Last Update Submitted That Met QC Criteria: July 1, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: device; electrophysiology; remote monitoring; technical support
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Heart Failure
• Other Study ID Numbers: #224

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No