Electronic Device Implantation Through Remote Guidance

Heart Failure Clinical Trial

Official title:

Randomized Open-label Single-center Trial on Remote Assistance Implementing Certified Specialized Engineers During Interventional Cardiology Procedures

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06404021
• Other study ID #: #224
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 1, 2022
• Est. completion date: April 30, 2024

Study information

• Verified date: May 2024
• Source: University of Calabria
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. completion date: April 30, 2024
• Est. primary completion date: September 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Defibrillators
• Heart Failure
• Telemedicine

Intervention

Other:
• interventional cardiology procedures with proctoring system
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 laboratory
Biomedical engineers supervise the performance of interventional cardiology procedures in the electrophysiology laboratory.

Locations

Country	Name	City	State
Italy	"Magna Graecia" University of Catanzaro	Catanzaro

Sponsors (1)

Lead Sponsor	Collaborator
University of Calabria

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of interventional cardiology procedures with remote assistance implementing certified specialized engineers	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).	From enrollment to the end of treatment at 12 months
Primary	Stability of interventional cardiology procedures results	The safety of remote monitoring interventional procedures is determined by the stability of the electronic parameters at discharge and follow-ups. The stability of the end-of-procedure parameters (pacing thresholds) was achieved if there were no significant changes in their measurements during the follow-ups.	From enrollment to the end of treatment at 12 months
Primary	Radiation exposure	Investigators evaluate and compare both for standard approach and telemedicine driven procedures the exposure to X-rays by accessing the official report from the dedicated system that the dosimetry company provided to the lab of interventional cardiology. Entrance dose at patient plane is the cumulative dose of radiation exposure at the patient entrance reference point and it is expressed in milliGray. The amount of ionization is proportional both to the dose and to the area of radiation's beam. Therefore, also dose area production is obtained measuring the product of radiations dose and area with unit of microGray per square meter.	The time in minutes from the beginning up to the end of interventional cardiology procedures
Primary	Electrophysiology laboratory occupancy	Investigators determined the duration of interventional procedures in minutes and compared this result both for standard and telemedicine driven approach.	The time in minutes from the beginning up to the end of interventional cardiology procedures