Electronic Device Implantation Through Remote Guidance

NCT06404021 | Completed Results

• 1 other identifier: #224
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

electrophysiology; remote monitoring; technical support; device

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (2)

Interventional cardiology procedures with engineer in remote support

EXPERIMENTAL

Other: interventional cardiology procedures with proctoring system

Interventional cardiology procedures with engineer in the electrophysiology laboratory

ACTIVE COMPARATOR

Other: interventional cardiology procedures with engineer in the electrophysiology laboratory

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 remote support

interventional cardiology procedures with engineer in the electrophysiology laboratory OTHER

Biomedical engineers supervise the performance of interventional cardiology procedures in the electrophysiology laboratory.

Interventional cardiology procedures with engineer in the electrophysiology laboratory

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Pacemaker dependent patients
• Patients who underwent generator replacement procedures

Sponsors & Collaborators

• University of Calabria: lead

Study Sites (1)

"Magna Graecia" University of Catanzaro

Catanzaro, 88100, Italy

Location

MeSH Terms

Conditions

Heart Failure

Interventions

Engineering

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Technology, Industry, and Agriculture

Results Point of Contact

• Title: Antonio Curcio
• Organization: University of Calabria

antonio.curcio.cardio@unical.it

+390984681889

Study Officials

• Antonio Curcio

  University of Calabria

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: April 26, 2024
• First Posted: May 8, 2024
• Study Start: June 1, 2022
• Primary Completion: September 30, 2023
• Study Completion: October 30, 2024
• Last Updated: July 20, 2025
• Results First Posted: July 20, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)