Skip to main content
OpenTrials
Completed

NCT Number: NCT06404021

Electronic Device Implantation Through Remote Guidance

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Telemedicine Cardiovascular Diseases Defibrillators Heart Diseases Heart Failure

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

"Magna Graecia" University of Catanzaro

Catanzaro, 88100, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Percentage of Participants With Interventional Procedures Successfully Completed

    Time frame: From enrollment to the end of treatment at 12 months

    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).

  2. Mean Pacing Threshold at 12-Month Follow-Up

    Time frame: 12-month follow-up visit

    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.

  3. Fluoroscopy Time (Minutes) During Cardiac Device Implantation With or Without Remote Assistance

    Time frame: During the interventional procedure up to 2 hours

    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.

  4. Electrophysiology Laboratory Occupancy

    Time frame: The time in minutes during procedure

    Investigators determined the duration of interventional procedures in minutes and compared this result both for standard and telemedicine driven approach.

Sponsors and collaborators

Lead sponsor

University of Calabria

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
May 8, 2024
Registry last updated
Jul 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.