Trial results for a study on electronic device implantation through remote guidance for Heart Failure patients were posted on ClinicalTrials.gov on 2025-07-20, indicating that remote support led to a mean fluoroscopy time of 6 minutes compared to 8 minutes for in-lab engineer support.
Background
Implantable cardioverter defibrillators (ICD) and cardiac resynchronization therapy defibrillators (CRT-D) are vital treatments for patients with heart failure, helping to manage life-threatening arrhythmias and improve cardiac function. However, the widespread availability and cost-effectiveness of these procedures can be constrained by the need for specialized field clinical specialist (FCS) bioengineers to be physically present in the electrophysiology laboratory. This can create geographical barriers to care and logistical challenges, particularly in underserved areas or during public health crises like pandemics. Exploring alternative methods, such as remotely supported implantations, is crucial for enhancing efficiency, reducing costs, and expanding access to these critical cardiac device procedures.
Trial design
This completed study, identified as Phase NA, enrolled 30 participants. The trial investigated the feasibility of remotely supported implantations of ICDs and CRT-Ds through an internet-based platform. The study included two phases: an initial phase of programming and phantom assessments in 20 cases, followed by 10 remote-guided CRT-D and ICD implantations in heart failure patients. These remote-guided procedures were compared against 20 procedures performed with an engineer present in the electrophysiology laboratory. The conditions under investigation included Telemedicine, Heart Failure, and Defibrillators.
Key results
The trial results highlighted several key measurements comparing remotely supported implantations to those with an in-lab engineer:
- Percentage of Participants With Interventional Procedures Successfully Completed: The number of participants for whom interventional procedures were successfully completed was 10 in the group with engineer in remote support and 20 in the group with engineer in the electrophysiology laboratory.
- Mean Pacing Threshold at 12-Month Follow-Up: The mean pacing threshold was 0.42 Volt (Standard Deviation 0.12) for the remote support group and 0.42 Volt (Standard Deviation 0.098) for the in-lab engineer group.
- Fluoroscopy Time (Minutes) During Cardiac Device Implantation With or Without Remote Assistance: The mean fluoroscopy time was 6 minutes (Standard Deviation 4) for the remote support group, compared to 8 minutes (Standard Deviation 8) for the in-lab engineer group.
- Electrophysiology Laboratory Occupancy: The mean electrophysiology laboratory occupancy was 84 minutes (Standard Deviation 6.5) for the remote support group, versus 103 minutes (Standard Deviation 28) for the in-lab engineer group.
What this means
The findings suggest that remote guidance for electronic device implantation in heart failure patients can achieve comparable clinical outcomes while improving procedural efficiency. The identical mean pacing thresholds at 12-month follow-up indicate that remote support does not compromise the functional success of the implanted devices. Furthermore, the reduction in mean fluoroscopy time by 2 minutes and a decrease in mean electrophysiology laboratory occupancy by 19 minutes with remote assistance points to significant operational efficiencies. These results imply that telemedicine-supported procedures could help overcome barriers related to specialist availability and potentially reduce healthcare costs, ultimately expanding access to essential cardiac device therapies for heart failure patients.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT06404021, titled "Electronic Device Implantation Through Remote Guidance", were posted on 2025-07-20 on clinicaltrials.gov.