Electronic Device Implantation Through Remote Guidance

NCT ID: NCT06404021

Last Updated: 2025-07-20

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-01

Study Completion Date

2024-10-30

Brief Summary

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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.

Detailed Description

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Conditions

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Telemedicine Heart Failure Defibrillators

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Interventional cardiology procedures with engineer in remote support

Group Type EXPERIMENTAL

interventional cardiology procedures with proctoring system

Intervention Type OTHER

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

Group Type ACTIVE_COMPARATOR

interventional cardiology procedures with engineer in the electrophysiology laboratory

Intervention Type OTHER

Biomedical engineers supervise the performance of interventional cardiology procedures in the electrophysiology laboratory.

Interventions

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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

Intervention Type OTHER

interventional cardiology procedures with engineer in the electrophysiology laboratory

Biomedical engineers supervise the performance of interventional cardiology procedures in the electrophysiology laboratory.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Calabria

OTHER

Sponsor Role lead

Responsible Party

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Antonio Curcio

MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Antonio Curcio

Role: PRINCIPAL_INVESTIGATOR

University of Calabria

Locations

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"Magna Graecia" University of Catanzaro

Catanzaro, , Italy

Site Status

Countries

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Italy

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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#224

Identifier Type: -

Identifier Source: org_study_id

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