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Impact on Patient Outcome of Cardiac Implantable Electronic Device Complications

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03612635
Acronym
POINTED
Enrollment
2811
Registered
2018-08-02
Start date
2010-01-01
Completion date
2017-02-01
Last updated
2018-08-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Implantable Electronic Device Complications

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.

Interventions

DEVICEImplantation of a cardiac implantable electronic device

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

Sponsors

Azienda Ospedaliera Cardinale G. Panico
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
All-cause Death (dead/alive status assessment during follow-up)An average of 48 monthsEvaluation of all-cause mortality during follow-up

Secondary

MeasureTime frameDescription
Occurrence of hospitalizations related to cardiac implantable electronic device complicationsAn average of 48 monthsEvaluation of hospitalizations related to cardiac implantable electronic device complications

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 28, 2026