Monaldi Hospital Rhythm Registry

University of Campania "Luigi Vanvitelli"

Status: Enrolling

Conditions: Pacemaker; ICD; Implanted Loop Recorder

Treatments: Device: Device implantation

Study type: Observational

Funder types: Other

Identifiers

NCT05072119

22052021

Details and patient eligibility

About

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.

Enrollment: 5,000 estimated patients

Sex: All

Ages: 14+ years old

Volunteers: No 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

Trial design

5,000 participants in 3 patient groups

Patients with PM

Description:

All patients underwent PM implantation

Treatment:

Device: Device implantation

Patients with ICD

Description:

All patients undeerwent ICD implantation

Treatment:

Device: Device implantation

Patients with ILR

Description:

All patients underwent ILR implantation

Treatment:

Device: Device implantation