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OpenTrials
Completed

NCT Number: NCT03612635

Impact on Patient Outcome of Cardiac Implantable Electronic Device 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.

Completed

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Key information

Conditions

Cardiac Implantable Electronic Device Complications

Sex eligibility

All sexes

Study type

Observational

Primary location

"Card. G. Panico" Hospital, Tricase, Lecce, Italy

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Implantation of a cardiac implantable electronic device

Device

All patients enrolled in the registry underwent cardiac implantable electronic device implantation

Primary outcomes

  1. 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

  1. Occurrence of hospitalizations related to cardiac implantable electronic device complications

    Time frame: An average of 48 months

    Evaluation of hospitalizations related to cardiac implantable electronic device complications

Sponsors and collaborators

Lead sponsor

Azienda Ospedaliera Cardinale G. Panico

Other

Registry information

Official study title

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

Acronym: POINTED

Important dates

Study start
2010
Primary completion
2012
Study completion
2017
First posted
Aug 2, 2018
Registry last updated
Aug 2, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.