Monaldi Hospital Rhythm Registry

Pacemaker Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05072119
• Other study ID #: 22052021
• Status: Recruiting
• Start date: January 7, 2015
• Est. completion date: January 2050

Study information

• Verified date: October 2021
• Source: University of Campania "Luigi Vanvitelli"
• Contact: Vincenzo Russo, MD PhD
• Phone: +390817062355
• Email: vincenzo.russo[@]unicampania.it
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5000
• Est. completion date: January 2050
• Est. primary completion date: January 7, 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years and older

Eligibility

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

Related Conditions & MeSH terms

• ICD
• Pacemaker

Intervention

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

Locations

Country	Name	City	State
Italy	Vincenzo Russo	Naples	Napoli

Sponsors (1)

Lead Sponsor	Collaborator
University of Campania "Luigi Vanvitelli"

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CIEDs Infection	The number of patecipants with infections following implantation of cardiac implantable electronic devices	through study completion, an average of 1 year
Primary	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
Primary	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