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Recruiting

NCT Number: NCT05072119

Monaldi Hospital Rhythm Registry

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.

Recruiting

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Key information

Conditions

Pacemaker ICD Implanted Loop Recorder

Age range

14 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Vincenzo Russo

Naples, Napoli, 80136, Italy

Location status: Recruiting

Location contact

Vincenzo Russo, MD PhD

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Device implantation

Device

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

Primary outcomes

  1. CIEDs Infection

    Time frame: 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

    Time frame: 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

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Vincenzo Russo, MD PhD

CONTACT

[email protected]

+390817062355

Sponsors and collaborators

Lead sponsor

University of Campania Luigi Vanvitelli

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2030
Study completion
2050
First posted
Oct 8, 2021
Registry last updated
Oct 15, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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