Impact on Patient Outcome of Cardiac Implantable Electronic Device Complications

Completed

• Conditions: Cardiac Implantable Electronic Device Complications

• Registration Number: NCT03612635
• Lead Sponsor: Azienda Ospedaliera Cardinale G. Panico

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.

Study Timeline

• Study Start: 2010-01-01
• Primary Completion: 2012-12-31
• Study Completion: 2017-02-01
• Status Verified: 2018-07
• Study First Submitted: 2018-07-19
• Study First Submitted QC: 2018-07-27
• Last Update Submitted: 2018-07-27
• Study First Posted: 2018-08-02
• Last Update Posted: 2018-08-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2811

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
All-cause Death (dead/alive status assessment during follow-up)	An average of 48 months	Evaluation of all-cause mortality during follow-up

Secondary Outcome Measures

Name	Time	Method
Occurrence of hospitalizations related to cardiac implantable electronic device complications	An average of 48 months	Evaluation of hospitalizations related to cardiac implantable electronic device complications

Trial Locations

Locations (6)

Mattia Laffi; 🇮🇹 Genova, Italy

Monaldi Hospital; 🇮🇹 Napoli, Italy

"Card. G. Panico" Hospital; 🇮🇹 Tricase, Lecce, Italy

Federico Guerra; 🇮🇹 Ancona, Italy

Policlinico S.Orsola-Malpighi; 🇮🇹 Bologna, Italy

AOU "Maggiore della Carità"; 🇮🇹 Novara, Italy