Monaldi Hospital Rhythm Registry
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age14+
SponsorUniversity of Campania Luigi Vanvitelli
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
No informed consent
Patient is participating in another clinical study that may have an impact on the study endpoint
No informed consent
Trial population
This study requires patients implanted with PM/ICD/ILR that meet all inclusion/exclusion criteria.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Device implantation
DeviceImplantation of single chamber, dual chambers or triple chambers PM/ICD
Treatment groups
5,000 Participants
are divided into 3 treatment groupsGroup A: Patients with PM1 intervention
Group B: Patients with ICD1 intervention
Group C: Patients with ILR1 intervention
Trial outcomes
Primary outcomes
1
CIEDs Infection
The number of patecipants with infections following implantation of cardiac implantable electronic devices
Time frame
through study completion, an average of 1 year2
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.
Time frame
through study completion, an average of 1 year3
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.
Time frame
through study completion, an average of 1 yearSponsors and contacts
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Source ClinicalTrials.gov