Monaldi Hospital Rhythm Registry

Recruiting

• Conditions: Pacemaker; ICD; Implanted Loop Recorder
• Interventions: Device: Device implantation

• Registration Number: NCT05072119
• Lead Sponsor: University of Campania "Luigi Vanvitelli"

Brief Summary

The study is a prospective registry. Consecutive patients with indications of implant / replacement or upgrade of pacemaker (PM), implantable cardioverter defibrillator (ICD), Implanted loop recorder (ILR) will be enrolled.

The primary objective of the study is to describe the clinical events during a long-term follow-up of non-selected population of patients implanted with an PM, ICD or ILR.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-01-07
• Study First Submitted: 2021-09-14
• Study First Submitted QC: 2021-09-27
• Status Verified: 2021-10
• Study First Posted: 2021-10-08
• Last Update Submitted: 2021-10-08
• Last Update Posted: 2021-10-15
• Primary Completion: 2030-01-07
• Study Completion: 2050-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 5000

Inclusion Criteria

• All consecutive patients underwent PM/ICD/ILR implantation
• Patient is willing and able to sign an authorization to use and disclose health information or an Informed Consent
• Patient must be able to attend all required follow-up visits at the study center for at least 12 months

Exclusion Criteria

• No informed consent
• Patient is participating in another clinical study that may have an impact on the study endpoint

Exclusion Criteria:

• No informed consent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with PM	Device implantation	All patients underwent PM implantation
Patients with ILR	Device implantation	All patients underwent ILR implantation
Patients with ICD	Device implantation	All patients undeerwent ICD implantation

Primary Outcome Measures

Name	Time	Method
CIEDs Infection	through study completion, an average of 1 year	The number of patecipants with infections following implantation of cardiac implantable electronic devices
Inappropriate ICD Therapies	through study completion, an average of 1 year	The number of partecipants with at least one episode of antitachycardia pacing therapy or shock delivered by ICD for device detected sopraventricular arrhythmias.
Appropriate ICD Therapies Antitachycardia pacing therapy or shock delivered by ICD for device detected ventricular arrhythmia	through study completion, an average of 1 year	The number of partecipants with a least one episode of antitachycardia pacing therapy or shock delivered by ICD for device detected ventricular arrhythmias.

Trial Locations

Locations (1)

Vincenzo Russo; 🇮🇹 Naples, Napoli, Italy