Registry of patients with pacemakers and defibrillators
Registry of Patients Underwent Cardiac Implanted Electronic Device Implantation at Monaldi Hospital
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 |
|---|---|
| Enrollment | 5000 (estimated) |
| Ages | 14 Years and up |
| Sex | All |
| Sponsor | University of Campania Luigi Vanvitelli Academic / other |
| Locations | 1 site (Naples, Napoli) |
| Trial ID | NCT05072119 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: Other observational registries have shown success in documenting patient outcomes with similar cardiac devices, indicating that this approach is validated in the field.
Eligibility criteria
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 this trial is running
Naples, Napoli
- Vincenzo Russo — Naples, Napoli, Italy (Recruiting)
Study contacts
- Study coordinator: Vincenzo Russo, MD PhD
- Email: vincenzo.russo@unicampania.it
- Phone: +390817062355
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.