Monaldi Hospital Rhythm Registry

NCT ID: NCT05072119

Last Updated: 2021-10-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

5000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-01-07

Study Completion Date

2050-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Pacemaker ICD Implanted Loop Recorder

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with PM

All patients underwent PM implantation

Device implantation

Intervention Type DEVICE

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

Patients with ICD

All patients undeerwent ICD implantation

Device implantation

Intervention Type DEVICE

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

Patients with ILR

All patients underwent ILR implantation

Device implantation

Intervention Type DEVICE

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

Interventions

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Device implantation

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

Intervention Type DEVICE

Eligibility Criteria

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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


* No informed consent
Minimum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Campania Luigi Vanvitelli

OTHER

Sponsor Role lead

Responsible Party

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Vincenzo Russo

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Vincenzo Russo, MD PhD

Role: STUDY_CHAIR

University of Campania Luigi Vanvitelli

Locations

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Vincenzo Russo

Naples, Napoli, Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Vincenzo Russo, MD PhD

Role: CONTACT

+390817062355

Facility Contacts

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Vincenzo Russo, MD PhD

Role: primary

Other Identifiers

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22052021

Identifier Type: -

Identifier Source: org_study_id