OBSERVational Registry on Long-term Outcome of ICD Patients

NCT ID: NCT02735811

Last Updated: 2016-04-13

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

UNKNOWN

Total Enrollment

1300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-03-31

Study Completion Date

2016-05-31

Brief Summary

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Multicentric, observational, retrospective registry including patients underwent ICD implantation for any indication. The primary aim of the registry is to evaluate the long-term outcome of patients receiving an ICD.

Detailed Description

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Multicentric, observational, retrospective registry including patients underwent ICD implantation for any indication in the period from 2010 to 2012. The aims of the registry are to evaluate the occurrence of complications related to ICD implantation (including ICD shocks and electrical storm), and the mortality during a long-term follow-up.

Conditions

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Cardiomyopathies

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Interventions

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Assesment of long-term outcome of ICD patients

Evaluation during follow-up of the occurrence of complications related to ICD implantation and of death

Intervention Type DEVICE

Other Intervention Names

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Implantable Cardioverter Defibrillator

Eligibility Criteria

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Inclusion Criteria

* ICD implantation fo any indication;
* age \>18 years

Exclusion Criteria

* life expectancy of less than one year
Minimum Eligible Age

18 Years

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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Pietro Palmisano

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Pietro Palmisano, MD

Role: PRINCIPAL_INVESTIGATOR

Cardiology Unit - "Card. G. Panico" Hospital - Tricase

Locations

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University Hospital "Umberto I - Lancisi - Salesi"

Ancona, Ancona, Italy

Site Status RECRUITING

Policlinico S.Orsola-Malpighi

Bologna, Bologna, Italy

Site Status RECRUITING

AO Pugliese-Ciaccio

Catanzaro, Catanzaro, Italy

Site Status RECRUITING

"Card. G. Panico" Hospital

Tricase, Lecce, Italy

Site Status RECRUITING

Ospedale Maggiore della Carità

Novara, Novara, Italy

Site Status RECRUITING

Ospedale San Filippo Neri

Roma, Roma, Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Pietro Palmisano, MD

Role: CONTACT

+390833542430

Facility Contacts

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Federico Guerra, MD

Role: primary

Matteo Ziacchi, MD

Role: primary

+393476785656

Vittorio Aspromonte, MD

Role: primary

+393472536524

Pietro Palmisano, MD

Role: primary

Gabriele Dell'Era, MD

Role: primary

Stefano Aquilani, MD

Role: primary

+393479657114

References

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Guerra F, Palmisano P, Dell'Era G, Ziacchi M, Ammendola E, Bonelli P, Patani F, Cupido C, Devecchi C, Accogli M, Occhetta E, Santangelo L, Biffi M, Boriani G, Capucci A; Italian Association of Arrhythmology and Cardiac Pacing (AIAC). Implantable cardioverter-defibrillator programming and electrical storm: Results of the OBSERVational registry On long-term outcome of ICD patients (OBSERVO-ICD). Heart Rhythm. 2016 Oct;13(10):1987-92. doi: 10.1016/j.hrthm.2016.06.007. Epub 2016 Jun 9.

Reference Type DERIVED
PMID: 27291511 (View on PubMed)

Other Identifiers

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OBSERVO

Identifier Type: -

Identifier Source: org_study_id

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