Monaldi Hospital Rhythm Registry

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

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.

Study Overview

• Status: Recruiting
• Conditions: Pacemaker; ICD; Implanted Loop Recorder
• Intervention / Treatment: Device: Device implantation

• Study Type: Observational
• Enrollment (Anticipated): 5000

Contacts and Locations

• Study Contact: Name: Vincenzo Russo, MD PhD; Phone Number: +390817062355; Email: vincenzo.russo@unicampania.it

Study Locations

• Italy
  • Napoli
    • Naples, Napoli, Italy, 80136
      • Recruiting
      • Vincenzo Russo
      • Contact: Vincenzo Russo, MD PhD; Email: v.p.russo@libero.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients with PM; All patients underwent PM implantation	Device: Device implantation; Implantation of single chamber, dual chambers or triple chambers PM/ICD
Patients with ICD; All patients undeerwent ICD implantation	Device: Device implantation; Implantation of single chamber, dual chambers or triple chambers PM/ICD
Patients with ILR; All patients underwent ILR implantation	Device: Device implantation; Implantation of single chamber, dual chambers or triple chambers PM/ICD

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Campania "Luigi Vanvitelli"
• Investigators: Study Chair: Vincenzo Russo, MD PhD, University of Campania "Luigi Vanvitelli"

Study record dates

Study Major Dates

• Study Start (Actual): January 7, 2015
• Primary Completion (Anticipated): January 7, 2030
• Study Completion (Anticipated): January 1, 2050

Study Registration Dates

• First Submitted: September 14, 2021
• First Submitted That Met QC Criteria: September 27, 2021
• First Posted (Actual): October 8, 2021

Study Record Updates

• Last Update Posted (Actual): October 15, 2021
• Last Update Submitted That Met QC Criteria: October 8, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: 22052021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No