Monaldi Hospital Rhythm Registry

NCT05072119 · tracked via the Priya Life Science Italy tracker

Sponsor

University of Campania Luigi Vanvitelli

Phase

Observational

Started

2015-01-07

Last updated

2021-10-15

Condition(s) studied

PacemakerICDImplanted Loop Recorder

Investigational drug(s) / intervention(s)

Device implantation

Device implantation: Implantation of single chamber, dual chambers or triple chambers PM/ICD

Study 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.

Eligibility

Sex

ALL

Min age

14 Years

Max age

—

Healthy volunteers

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

Primary outcome measure(s)

CIEDs Infection — through study completion, an average of 1 year
The number of patecipants with infections following implantation of cardiac implantable electronic devices
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.
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.

Trial sites (1)

Facility	City	Region	Status
Vincenzo Russo	Naples	Napoli	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05072119 on ClinicalTrials.gov ↗ ← All trials in Italy