Monaldi Hospital Rhythm Registry

Registry of Patients Underwent Cardiac Implanted Electronic Device Implantation at Monaldi Hospital

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05072119

Enrollment

5000

Registered

2021-10-08

Start date

2015-01-07

Completion date

2050-01-31

Last updated

2021-10-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ICD, Implanted Loop Recorder, Pacemaker

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.

Interventions

DEVICEDevice implantation

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

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

14 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

Italy

Contacts

Primary ContactVincenzo Russo, MD PhD

vincenzo.russo@unicampania.it+390817062355

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026