Impact on Patient Outcome of Cardiac Implantable Electronic Device Complications

NCT ID: NCT03612635

Last Updated: 2018-08-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

2811 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-01-01

Study Completion Date

2017-02-01

Brief Summary

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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

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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.

Conditions

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Cardiac Implantable Electronic Device Complications

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Implantation of a cardiac implantable electronic device

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

Intervention Type DEVICE

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Azienda Ospedaliera Cardinale G. Panico

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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"Card. G. Panico" Hospital

Tricase, Lecce, Italy

Site Status

Federico Guerra

Ancona, , Italy

Site Status

Policlinico S.Orsola-Malpighi

Bologna, , Italy

Site Status

Mattia Laffi

Genova, , Italy

Site Status

Monaldi Hospital

Napoli, , Italy

Site Status

AOU "Maggiore della Carità"

Novara, , Italy

Site Status

Countries

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Italy

References

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Palmisano P, Sergi C, Panico V, Chiarillo MV, Chiuri MD, Martella ML, Stefanelli G, Martella D, Mauro R, Ponzetta MA, Parlavecchio A, Accogli M, Coluccia G. Impact on nurse workload and patient satisfaction of atrioventricular junction ablation performed simultaneously with conduction system pacing using a superior approach from the pocket compared with the conventional femoral approach. Eur J Cardiovasc Nurs. 2024 Oct 21;23(7):746-755. doi: 10.1093/eurjcn/zvae043.

Reference Type DERIVED
PMID: 38552177 (View on PubMed)

Other Identifiers

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POINTED

Identifier Type: -

Identifier Source: org_study_id

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