Monaldi Hospital Rhythm Registry

• Sponsor: University of Campania "Luigi Vanvitelli" (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05072119
• Collaborator: (none)
• Enrollment: 5,000
• Location: 1
• Anticipated Duration (Months): 419.8
• Patients Per Site Per Month: 11.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pacemaker; ICD; Implanted Loop Recorder	Device: Device implantation

Study Design

• Study Type: Observational [Patient Registry]
• Anticipated Enrollment: 5000 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Registry of Patients Underwent Cardiac Implanted Electronic Device Implantation at Monaldi Hospital
• Actual Study Start Date: Jan 7, 2015
• Anticipated Primary Completion Date: Jan 7, 2030
• Anticipated Study Completion Date: Jan 1, 2050

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. CIEDs Infection [through study completion, an average of 1 year]

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

2. 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.

3. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 14 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Vincenzo Russo	Naples	Napoli	Italy	80136

Sponsors and Collaborators

• University of Campania "Luigi Vanvitelli"

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Vincenzo Russo, Principal Investigator, University of Campania "Luigi Vanvitelli"
• ClinicalTrials.gov Identifier: NCT05072119
• Other Study ID Numbers: 22052021
• First Posted: Oct 8, 2021
• Last Update Posted: Oct 15, 2021
• Last Verified: Oct 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Oct 15, 2021