N/A
N=30
Electronic Device Implantation Through Remote Guidance
Telemedicine · Heart Failure · Defibrillators
Bottom Line
View on ClinicalTrials.gov: NCT06404021 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Jul 2025
Primary outcome: Primary: Percentage of Participants With Interventional Procedures Successfully Completed — 10; 20 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- interventional cardiology procedures with proctoring system (Other); interventional cardiology procedures with engineer in the electrophysiology laboratory (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Calabria
- Primary completion
- Sep 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Interventional Procedures Successfully Completed |
10; 20 | — |
| PRIMARY Mean Pacing Threshold at 12-Month Follow-Up |
0.42; 0.42 | — |
| PRIMARY Fluoroscopy Time (Minutes) During Cardiac Device Implantation With or Without Remote Assistance |
6; 8 | — |
| PRIMARY Electrophysiology Laboratory Occupancy |
84; 103 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT06404021). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.