NCT03612635
Completed
Not Applicable
Impact on Patient Outcome and Healthcare Utilization of Cardiac ImplaNTable Electronic Devices Complications
Azienda Ospedaliera Cardinale G. Panico6 sites in 1 country2,811 target enrollmentJanuary 1, 2010
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Cardiac Implantable Electronic Device Complications
- Sponsor
- Azienda Ospedaliera Cardinale G. Panico
- Enrollment
- 2811
- Locations
- 6
- Primary Endpoint
- All-cause Death (dead/alive status assessment during follow-up)
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
The purpose of this registry is to evaluate the impact on patient outcome and on healthcare utilization of cardiac implantation electronic device complications during a long-term follow-up.
Detailed Description
Multicentric, observational, prospective registry enrolling consecutive patients underwent pacemaker or defibrillator implantation, aimed to evaluate the impact of cardiac implantable device complications requiring surgical revision on healthcare utilization (number and length of hospitalizations), and on patient outcome (all-cause mortality and cardiac mortality), during a long-term follow-up.
Investigators
Eligibility Criteria
Inclusion Criteria
- •patients underwent cardiac implantable electronic device implantation according to current guidelines during the enrollment period.
Exclusion Criteria
- •patients already carriers of a cardiac implantable electronic device underwent replacement or upgrading of device.
Outcomes
Primary Outcomes
All-cause Death (dead/alive status assessment during follow-up)
Time Frame: An average of 48 months
Evaluation of all-cause mortality during follow-up
Secondary Outcomes
- Occurrence of hospitalizations related to cardiac implantable electronic device complications(An average of 48 months)
Study Sites (6)
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