PacemakerNCT05072119
Monaldi Hospital Rhythm Registry
An observational study of Pacemaker and ICD, run by University of Campania Luigi Vanvitelli at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- Pacemaker, ICD, Implanted Loop Recorder
- What is being tested?
- Device implantation
- Type of treatment
- Medical device
- How many people
- 5,000 participants
- Where
- 1 siteItaly
- Study dates
- 7 Jan 2015to Jan 2050
- How long will I take part?
- 20 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: This study requires patients implanted with PM/ICD/ILR that meet all inclusion/exclusion criteria.
Who may be able to join
- 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
Who cannot join
- No informed consent
- Patient is participating in another clinical study that may have an impact on the study endpoint
- No informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Vincenzo Russo
Naples, Napoli, 80136
Vincenzo Russo, MD PhD, v.p.russo@libero.it
About this study
Official title: Registry of Patients Underwent Cardiac Implanted Electronic Device Implantation at Monaldi Hospital
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.
- Conditions
- Pacemaker, ICD, Implanted Loop Recorder
- Being tested
- Device implantation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Device implantationDevice
Implantation of single chamber, dual chambers or triple chambers PM/ICD
| Study group | Role | What they receive |
|---|---|---|
| Patients with PM | All patients underwent PM implantation Receives: Device: Device implantation | |
| Patients with ICD | All patients undeerwent ICD implantation Receives: Device: Device implantation | |
| Patients with ILR | All patients underwent ILR implantation Receives: Device: Device implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
CIEDs Infection
The number of patecipants with infections following implantation of cardiac implantable electronic devices
Measured: through study completion, an average of 1 year
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.
Measured: through study completion, an average of 1 year
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.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2021
- Study start7 Jan 2015
- Primary completion7 Jan 2030 (estimated)
- Study completionJan 2050 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PacemakerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5,000 participants (estimated)
- Target duration
- 20 Years
Sponsor and investigators
- Lead sponsor
- University of Campania Luigi Vanvitelli
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vincenzo Russo, University of Campania Luigi Vanvitelli
- Investigators
- Vincenzo Russo, MD PhD, Study chair, University of Campania Luigi Vanvitelli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05072119
- Sponsor's protocol ID
- 22052021
- Status last verified
- Oct 2021
- First submitted
- 14 Sep 2021
- Last updated
- 15 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Registry of Patients Underwent Cardiac Implanted Electronic Device Implantation at Monaldi Hospital
- ClinicalTrials.gov ID
- NCT05072119
- Acronym / sponsor ID
- 22052021
- Conditions
- Pacemaker, ICD, Implanted Loop Recorder
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- University of Campania Luigi VanvitelliUniversity, hospital or other
- Study start
- 7 Jan 2015 (actual)
- Primary completion
- 7 Jan 2030 (estimated)
- Study completion
- Jan 2050 (estimated)
- First posted
- 8 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 20 Years
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patients with PM | – | Device: Device implantationAll patients underwent PM implantation |
| Patients with ICD | – | Device: Device implantationAll patients undeerwent ICD implantation |
| Patients with ILR | – | Device: Device implantationAll patients underwent ILR implantation |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- This study requires patients implanted with PM/ICD/ILR that meet all inclusion/exclusion criteria.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- No informed consent
- Patient is participating in another clinical study that may have an impact on the study endpoint
- No informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Device implantationImplantation of single chamber, dual chambers or triple chambers PM/ICD | Device | Patients with ICD, Patients with ILR, Patients with PM |
Primary outcome
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
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Vincenzo Russo, MD PhD study chair
University of Campania Luigi Vanvitelli
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pacemaker and ICD, run by University of Campania Luigi Vanvitelli at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Vincenzo Russo, MD PhD (+390817062355, vincenzo.russo@unicampania.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CIEDs Infection (time frame: through study completion, an average of 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2021; AzTrials last refreshed its copy on 29 Oct 2026.