Impact on Patient Outcome of Cardiac Implantable Electronic Device Complications

Cardiac Implantable Electronic Device Complications Clinical Trial

— POINTED  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03612635
• Other study ID #: POINTED
• Status: Completed
• Start date: January 1, 2010
• Est. completion date: February 1, 2017

Study information

• Verified date: July 2018
• Source: Azienda Ospedaliera Cardinale G. Panico
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2811
• Est. completion date: February 1, 2017
• Est. primary completion date: December 31, 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Cardiac Implantable Electronic Device Complications

Intervention

Device:
• Implantation of a cardiac implantable electronic device
All patients enrolled in the registry underwent cardiac implantable electronic device implantation

Locations

Country	Name	City	State
Italy	Federico Guerra	Ancona
Italy	Policlinico S.Orsola-Malpighi	Bologna
Italy	Mattia Laffi	Genova
Italy	Monaldi Hospital	Napoli
Italy	AOU "Maggiore della Carità"	Novara
Italy	"Card. G. Panico" Hospital	Tricase	Lecce

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Ospedaliera Cardinale G. Panico

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All-cause Death (dead/alive status assessment during follow-up)	Evaluation of all-cause mortality during follow-up	An average of 48 months
Secondary	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