Actively Recruiting

Age: 14Years +
All Genders
ID05072119

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

Led by University of Campania Luigi Vanvitelli · Updated on 2021-10-15

5000

Participants Needed

1

Research Sites

1042 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are conducting a prospective registry study to observe patients who receive implantations or replacements of cardiac devices such as pacemakers (PM), implantable cardioverter defibrillators (ICD), and implanted loop recorders (ILR). The study aims to describe clinical events over a long-term follow-up in an unselected population of patients with these devices. This registry is sponsored by the University of Campania Luigi Vanvitelli and tracks real-world outcomes related to these cardiac devices. Participants in the study have undergone implantation of either a single chamber, dual chamber, or triple chamber pacemaker or ICD, or an implanted loop recorder. The study groups include patients with PMs, ICDs, or ILRs. The registry collects data without altering patient care and monitors device-related events and therapies over time. During the study, patients will attend follow-up visits for at least 12 months at the study center. Researchers will monitor for infections related to cardiac implanted electronic devices, appropriate ICD therapies such as antitachycardia pacing or shocks, and inappropriate ICD therapies. This monitoring helps understand the safety and clinical outcomes associated with these devices over about one year on average, with ongoing data collection extending to a long-term follow-up period.

CONDITIONS

Brief Title

Monaldi Hospital Rhythm Registry

Who Can Participate

Age: 14Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • All consecutive patients who have undergone PM, ICD, or ILR implantation
  • Patients willing and able to sign an authorization to use and disclose health information or an Informed Consent
  • Patients able to attend all required follow-up visits at the study center for at least 12 months
Not Eligible

You will not qualify if you...

  • No informed consent
  • Participation in another clinical study that may impact the study endpoint

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Implementation

Duration - Day of implantation

Participants undergo implantation of a cardiac device such as a pacemaker, implantable cardioverter defibrillator, or implantable loop recorder.

1 visit (in-person)

Long-term Monitoring

Duration - Approximately 1 year

Participants are monitored for device-related infections and appropriate or inappropriate device therapies for approximately 1 year following implantation.

Regular follow-up visits during the year

Trial Site Locations

Total: 1 location

1

Vincenzo Russo

Naples, Napoli, Italy, 80136

Actively Recruiting

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Research Team

V

Vincenzo Russo, MD PhD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

3

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