Electronic Device Implantation Through Remote Guidance

Not Applicable

Completed

Conditions: Defibrillators
Telemedicine
Heart Failure

Registration Number: NCT06404021

Lead Sponsor: University of Calabria

Brief 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 30

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: FACTORIAL

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Interventional Procedures Successfully Completed	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	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	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	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.