Trial Outcomes & Findings for Electronic Device Implantation Through Remote Guidance (NCT NCT06404021)

Last Updated: 2025-07-20

Results Overview

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).

Recruitment status

COMPLETED

Study phase

Target enrollment

30 participants

Primary outcome timeframe

From enrollment to the end of treatment at 12 months

Results posted on

2025-07-20

Participant Flow

Participant milestones

Participant milestones
Measure	Interventional Cardiology Procedures With Engineer in Remote Support 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	Interventional Cardiology Procedures With Engineer in the Electrophysiology Laboratory interventional cardiology procedures with engineer in the electrophysiology laboratory: Biomedical engineers supervise the performance of interventional cardiology procedures in the electrophysiology laboratory.
Overall Study STARTED	10	20
Overall Study COMPLETED	10	20
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Electronic Device Implantation Through Remote Guidance

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Interventional Cardiology Procedures With Engineer in Remote Support n=10 Participants 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	Interventional Cardiology Procedures With Engineer in the Electrophysiology Laboratory n=20 Participants interventional cardiology procedures with engineer in the electrophysiology laboratory: Biomedical engineers supervise the performance of interventional cardiology procedures in the electrophysiology laboratory.	Total n=30 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	10 Participants n=5 Participants	20 Participants n=7 Participants	30 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	65 years STANDARD_DEVIATION 11 • n=5 Participants	64 years STANDARD_DEVIATION 11 • n=7 Participants	64 years STANDARD_DEVIATION 11 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	6 Participants n=7 Participants	9 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	14 Participants n=7 Participants	21 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	10 Participants n=5 Participants	20 Participants n=7 Participants	30 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment Italy	10 Participants n=5 Participants	20 Participants n=7 Participants	30 Participants n=5 Participants

PRIMARY outcome

Timeframe: From enrollment to the end of treatment at 12 months

Outcome measures

Outcome measures
Measure	Interventional Cardiology Procedures With Engineer in Remote Support n=10 Participants 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	Interventional Cardiology Procedures With Engineer in the Electrophysiology Laboratory n=20 Participants interventional cardiology procedures with engineer in the electrophysiology laboratory: Biomedical engineers supervise the performance of interventional cardiology procedures in the electrophysiology laboratory.
Percentage of Participants With Interventional Procedures Successfully Completed	10 Participants	20 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Interventional Cardiology Procedures With Engineer in Remote Support n=10 Participants 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	Interventional Cardiology Procedures With Engineer in the Electrophysiology Laboratory n=20 Participants interventional cardiology procedures with engineer in the electrophysiology laboratory: Biomedical engineers supervise the performance of interventional cardiology procedures in the electrophysiology laboratory.
Mean Pacing Threshold at 12-Month Follow-Up	0.42 Volt Standard Deviation 0.12	0.42 Volt Standard Deviation 0.098

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Interventional Cardiology Procedures With Engineer in Remote Support n=10 Participants 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	Interventional Cardiology Procedures With Engineer in the Electrophysiology Laboratory n=20 Participants interventional cardiology procedures with engineer in the electrophysiology laboratory: Biomedical engineers supervise the performance of interventional cardiology procedures in the electrophysiology laboratory.
Fluoroscopy Time (Minutes) During Cardiac Device Implantation With or Without Remote Assistance	6 minutes Standard Deviation 4	8 minutes Standard Deviation 8

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Interventional Cardiology Procedures With Engineer in Remote Support n=10 Participants 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	Interventional Cardiology Procedures With Engineer in the Electrophysiology Laboratory n=20 Participants interventional cardiology procedures with engineer in the electrophysiology laboratory: Biomedical engineers supervise the performance of interventional cardiology procedures in the electrophysiology laboratory.
Electrophysiology Laboratory Occupancy	84 minutes Standard Deviation 6.5	103 minutes Standard Deviation 28

Adverse Events

Interventional Cardiology Procedures With Engineer in Remote Support

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Interventional Cardiology Procedures With Engineer in the Electrophysiology Laboratory

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Antonio Curcio

University of Calabria

Phone: +390984681889

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place