Registry of patients with pacemakers and defibrillators
Official title: Registry of Patients Underwent Cardiac Implanted Electronic Device Implantation at Monaldi Hospital
Run by University of Campania Luigi Vanvitelli · NCT05072119 · Data updated 2026-11-12
This study is creating a registry to track the experiences and health outcomes of patients getting pacemakers or defibrillators to see how they do over time.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 14 Years and up |
| Sex | All |
| Enrollment | 5000 (estimated) |
| Sponsor | University of Campania Luigi Vanvitelli Academic / other |
| Locations | 1 site (Naples, Napoli) |
| Status | Recruiting |
| Started | January 7, 2015 |
| Main results expected | January 7, 2030 |
| Study ends | January 2050 |
| Registry record updated | October 15, 2021 |
| Trial ID | NCT05072119 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are patients who are scheduled for the implantation of a pacemaker, ICD, or ILR and are willing to participate in follow-up visits.
✕Probably not a fit
Patients who are unable to provide informed consent or are participating in other clinical studies that may affect the study outcomes may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to create a prospective registry of patients who are undergoing the implantation, replacement, or upgrade of pacemakers, implantable cardioverter defibrillators, or implanted loop recorders. It will enroll consecutive patients and follow them over the long term to document clinical events in a non-selected population. The study will focus on gathering data to better understand the outcomes and experiences of these patients post-implantation.
Why it matters
Potential benefit: If successful, this registry could provide valuable insights into the long-term outcomes of patients with cardiac devices, potentially improving patient care and management.
How similar studies have gone: Other observational registries have shown success in documenting patient outcomes with similar cardiac devices, indicating that this approach is validated in the field.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
Vincenzo Russo
Naples, Napoli, Italy Recruiting
Study contacts
- Study coordinator: Vincenzo Russo, MD PhD
- Email: vincenzo.russo@unicampania.it
- Phone: +390817062355
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Lead-related tricuspid valve leakage after first-time pacemaker or ICD implantation
This project will see if a new transvenous pacemaker or ICD lead causes new or worse tricuspid valve regurgitation in people getting their first device.
-
3D Echocardiography to See How CIEDs May Worsen Tricuspid Regurgitation
This study tests whether different CIEDs (leadless pacemakers, LBBaP, and conventional pacemakers) differ in causing worsening tricuspid regurgitation, using 3D heart imaging.
-
Higher pacemaker rate for people with cardiac amyloidosis
This study will see if temporarily increasing the pacemaker rate improves heart-failure symptoms and exercise tolerance in adults with cardiac amyloidosis who already have pacemakers.
-
Left bundle branch pacing plus ICD for people with hypertrophic cardiomyopathy after myectomy
This study will test whether adding left bundle branch pacing to a dual‑chamber ICD helps people with hypertrophic cardiomyopathy who develop left bundle branch block after myectomy to slow heart failure progression and prevent life‑threatening arrhythmias.
-
Leadless pacemaker outcomes and follow-up at University Hospital St. Pölten
This registry will collect and analyze outcomes and complications in adults who receive leadless pacemakers at University Hospital St. Pölten to see how the devices perform over time.
-
Left bundle branch area pacing versus conventional right‑ventricular pacing after TAVI for atrioventricular block
This will test whether left bundle branch area pacing works better than standard right‑ventricular pacing for people who need a pacemaker after TAVI.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.