TelemedicineNCT06404021
Electronic Device Implantation Through Remote Guidance
A study testing interventional cardiology procedures with proctoring system and interventional cardiology procedures with engineer in the electrophysiology laboratory in people with Telemedicine and Heart Failure, run by University of Calabria at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Telemedicine, Heart Failure, Defibrillators
- What is being tested?
- interventional cardiology procedures with proctoring system and interventional cardiology procedures with engineer in the electrophysiology laboratory
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jun 2022to 30 Oct 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Pacemaker dependent patients
- Patients who underwent generator replacement procedures
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Telemedicine, Heart Failure, Defibrillators
- Being tested
- interventional cardiology procedures with proctoring system, interventional cardiology procedures with engineer in the electrophysiology laboratory
- Keywords
- electrophysiology, remote monitoring, technical support, device
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
interventional cardiology procedures with proctoring systemOther
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 laboratoryOther
Biomedical engineers supervise the performance of interventional cardiology procedures in the electrophysiology laboratory.
| Study group | Role | What they receive |
|---|---|---|
| Interventional cardiology procedures with engineer in remote support | Experimental | Not described Receives: Other: interventional cardiology procedures with proctoring system |
| Interventional cardiology procedures with engineer in the electrophysiology laboratory | Active comparator | Not described Receives: Other: interventional cardiology procedures with engineer in the electrophysiology laboratory |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: The time in minutes during procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2024
- Study start1 Jun 2022
- Primary completion30 Sep 2023
- Study completion30 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for TelemedicineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Calabria
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Antonio Curcio, University of Calabria
- Investigators
- Antonio Curcio, Principal investigator, University of Calabria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06404021
- Sponsor's protocol ID
- #224
- Status last verified
- Jul 2025
- First submitted
- 26 Apr 2024
- Last updated
- 20 Jul 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Open-label Single-center Trial on Remote Assistance Implementing Certified Specialized Engineers During Interventional Cardiology Procedures
- ClinicalTrials.gov ID
- NCT06404021
- Acronym / sponsor ID
- #224
- Conditions
- Telemedicine, Heart Failure, Defibrillators
- Keywords
- electrophysiology, remote monitoring, technical support, device
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of CalabriaUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 30 Sep 2023 (actual)
- Study completion
- 30 Oct 2024 (actual)
- First posted
- 8 May 2024 (actual)
- Results
- Posted 20 Jul 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- Pacemaker dependent patients
- Patients who underwent generator replacement procedures
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| interventional cardiology procedures with proctoring systemInterventional procedures are performed by utilizing a monitoring platform that provides real-time support without engineer in the electrophysiology laboratory | Other | Interventional cardiology procedures with engineer in remote support |
| interventional cardiology procedures with engineer in the electrophysiology laboratoryBiomedical engineers supervise the performance of interventional cardiology procedures in the electrophysiology laboratory. | Other | Interventional cardiology procedures with engineer in the electrophysiology laboratory |
Primary outcome
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).
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.
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.
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Antonio Curcio principal investigator
University of Calabria
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing interventional cardiology procedures with proctoring system and interventional cardiology procedures with engineer in the electrophysiology laboratory in people with Telemedicine and Heart Failure, run by University of Calabria at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With Interventional Procedures Successfully Completed (time frame: From enrollment to the end of treatment at 12 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2025.