CompletedNot Applicable

Electronic Device Implantation Through Remote Guidance

Italy30 participantsStarted 2022-06-01

Plain-language 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.

Who can participate

Age range

18 Years – 85 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Percentage of Participants With Interventional Procedures Successfully Completed

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

Mean Pacing Threshold at 12-Month Follow-Up

Timeframe: 12-month follow-up visit

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

Timeframe: During the interventional procedure up to 2 hours

Electrophysiology Laboratory Occupancy

Timeframe: The time in minutes during procedure

Trial details

NCT IDNCT06404021

SponsorUniversity of Calabria

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-09-30

Results submitted2025-05-28

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