Monaldi Hospital Rhythm Registry

NCT05072119 | Recruiting

• 1 other identifier: 22052021
• Study Type: observational
• Target: 5,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Pacemaker; ICD; Implanted Loop Recorder

Outcome Measures

Primary Outcomes (3)

• CIEDs Infection

  The number of patecipants with infections following implantation of cardiac implantable electronic devices

  through study completion, an average of 1 year

• Appropriate ICD Therapies Antitachycardia pacing therapy or shock delivered by ICD for device detected ventricular arrhythmia

  The number of partecipants with a least one episode of antitachycardia pacing therapy or shock delivered by ICD for device detected ventricular arrhythmias.

  through study completion, an average of 1 year

• Inappropriate ICD Therapies

  The number of partecipants with at least one episode of antitachycardia pacing therapy or shock delivered by ICD for device detected sopraventricular arrhythmias.

  through study completion, an average of 1 year

Study Arms (3)

Patients with PM

All patients underwent PM implantation

Device: Device implantation

Patients with ICD

All patients undeerwent ICD implantation

Device: Device implantation

Patients with ILR

All patients underwent ILR implantation

Device: Device implantation

Interventions

Device implantation DEVICE

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

Patients with ICD; Patients with ILR; Patients with PM

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This study requires patients implanted with PM/ICD/ILR that meet all inclusion/exclusion criteria.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Campania Luigi Vanvitelli: lead

Study Sites (1)

Vincenzo Russo

Naples, Napoli, 80136, Italy

RECRUITING

Study Officials

• Vincenzo Russo, MD PhD

  University of Campania Luigi Vanvitelli

  STUDY CHAIR

Central Study Contacts

Vincenzo Russo, MD PhD

CONTACT

+390817062355; vincenzo.russo@unicampania.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 20 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 14, 2021
• First Posted: October 8, 2021
• Study Start: January 7, 2015
• Primary Completion (Estimated): January 7, 2030
• Study Completion (Estimated): January 1, 2050
• Last Updated: October 15, 2021

Record last verified: 2021-10

Locations

IT (1)