Registry of Patients Underwent Cardiac Implanted Electronic Device Implantation at Monaldi Hospital
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Pacemaker
- Sponsor
- University of Campania "Luigi Vanvitelli"
- Enrollment
- 5000
- Locations
- 1
- Primary Endpoint
- CIEDs Infection
- Status
- Recruiting
- Last Updated
- 4 years ago
Overview
Brief 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.
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.
Investigators
Vincenzo Russo
Principal Investigator
University of Campania "Luigi Vanvitelli"
Eligibility 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
Outcomes
Primary Outcomes
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
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.
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.