Impact on Patient Outcome of Cardiac Implantable Electronic Device Complications (POINTED)

Impact on Patient Outcome and Healthcare Utilization of Cardiac ImplaNTable Electronic Devices Complications

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.

Study Overview

• Status: Completed
• Conditions: Cardiac Implantable Electronic Device Complications
• Intervention / Treatment: Device: Implantation of a cardiac implantable electronic device

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 Type: Observational
• Enrollment (Actual): 2811

Contacts and Locations

Study Locations

• Italy
  • Ancona, Italy
    • Federico Guerra
  • Bologna, Italy, 40138
    • Policlinico S.Orsola-Malpighi
  • Genova, Italy
    • Mattia Laffi
  • Napoli, Italy
    • Monaldi Hospital
  • Novara, Italy, 28100
    • AOU "Maggiore della Carità"
  • Lecce
    • Tricase, Lecce, Italy, 73039
      • "Card. G. Panico" Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with indication to receive a cardiac implantable electronic device (pacemaker or defibrillator).

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All-cause Death (dead/alive status assessment during follow-up)	Evaluation of all-cause mortality during follow-up	An average of 48 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Occurrence of hospitalizations related to cardiac implantable electronic device complications	Evaluation of hospitalizations related to cardiac implantable electronic device complications	An average of 48 months

Collaborators and Investigators

• Sponsor: Azienda Ospedaliera Cardinale G. Panico

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2010
• Primary Completion (Actual): December 31, 2012
• Study Completion (Actual): February 1, 2017

Study Registration Dates

• First Submitted: July 19, 2018
• First Submitted That Met QC Criteria: July 27, 2018
• First Posted (Actual): August 2, 2018

Study Record Updates

• Last Update Posted (Actual): August 2, 2018
• Last Update Submitted That Met QC Criteria: July 27, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: POINTED

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No