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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Interventional cardiology procedures with engineer in remote support | Experimental |
| |
| Interventional cardiology procedures with engineer in the electrophysiology laboratory | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| interventional cardiology procedures with proctoring system | Other | Interventional procedures are performed by utilizing a monitoring platform that provides real-time support without engineer in the electrophysiology laboratory |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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. | 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. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Antonio Curcio | University of Calabria | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| "Magna Graecia" University of Catanzaro | Catanzaro | 88100 | Italy |
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| ID | Title | Description |
|---|---|---|
| FG000 | Interventional Cardiology Procedures With Engineer in Remote Support | 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 |
| FG001 | Interventional Cardiology Procedures With 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
both genders and in range 18 ÷ 85 years of age
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| ID | Title | Description |
|---|---|---|
| BG000 | Interventional Cardiology Procedures With Engineer in Remote Support | 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 |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | Posted | Count of Participants | Participants | From enrollment to the end of treatment at 12 months |
|
From device implantation through 12 months post-procedure, assessed at baseline, 6 months, and 12 months
All patients could be at risk of adverse events. All participants were monitored for serious adverse events throughout the study period.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Interventional Cardiology Procedures With Engineer in Remote Support | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Antonio Curcio | University of Calabria | +390984681889 | antonio.curcio.cardio@unical.it |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 17, 2021 | May 28, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 17, 2021 | May 28, 2025 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D004738 | Engineering |
| ID | Term |
|---|---|
| D013676 | Technology, Industry, and Agriculture |
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| interventional cardiology procedures with engineer in the electrophysiology laboratory | Other | Biomedical engineers supervise the performance of interventional cardiology procedures in the electrophysiology laboratory. |
|
| The time in minutes during procedure |
| Interventional Cardiology Procedures With 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
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 |
| OG001 | Interventional Cardiology Procedures With 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. |
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | Volt | 12-month follow-up visit |
|
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | minutes | During the interventional procedure up to 2 hours |
|
|
|
| Primary | Electrophysiology Laboratory Occupancy | Investigators determined the duration of interventional procedures in minutes and compared this result both for standard and telemedicine driven approach. | Posted | Mean | Standard Deviation | minutes | The time in minutes during procedure |
|
|
|
| 0 |
| 10 |
| 0 |
| 10 |
| 0 |
| 10 |
| EG001 | Interventional Cardiology Procedures With 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. | 0 | 20 | 0 | 20 | 0 | 20 |
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