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Multi-centre Observational Registry on Patients With Implantable Devices Remotely Monitored

NCT ID: NCT03061747

Last Updated: 2017-02-23

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

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-06-01

Study Completion Date

2017-04-30

Brief Summary

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Multicentric, observational, retrospective registry including patients underwent implantable device implantation (pacemaker or ICD) for any indication in the period from 2009 to 2016, followed by remote monitoring. The aims of the registry are to evaluate the occurrence of atrial arrhythmias, of hospitalizations, and the mortality during a long-term follow-up.

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Detailed Description

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Conditions

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Defibrillators, Implantable Heart Failure With Reduced Ejection Fraction Arrythmia Pacemaker

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Interventions

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Assesment of outcome of implantable device patients

Evaluation during follow-up of the occurrence of atrial arrhythmias, hospitalizations, and of death.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* ICD of pacemaker implantation fo any indication
* Followed by remote monitoring
* 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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Responsibility Role SPONSOR

Principal Investigators

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Pietro Palmisano, MD

Role: PRINCIPAL_INVESTIGATOR

Card. G. Panico Hospital - Tricase - Italy

Locations

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Policlinico S.Orsola-Malpighi

Bologna, Bologna, Italy

Site Status RECRUITING

AO Pugliese-Ciaccio

Catanzaro, Catanzaro, Italy

Site Status RECRUITING

Dell'Era Gabriele

Novara, Novara, Italy

Site Status RECRUITING

University Hospital "Umberto I - Lancisi - Salesi"

Ancona, , Italy

Site Status RECRUITING

Vito Fazzi Hospital

Lecce, , Italy

Site Status RECRUITING

Monaldi Hospital

Napoli, , Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Pietro Palmisano, MD

Role: CONTACT

[email protected]
+390833542430

Facility Contacts

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Matteo Ziacchi, MD

Role: primary

[email protected]
+393476785656

Vittorio Aspromonte, MD

Role: primary

[email protected]
+393472536524

Gabriele Dell'Era, MD

Role: primary

gdell'[email protected]

Federico Guerra, MD

Role: primary

[email protected]

Ennio C Pisanò, MD

Role: primary

[email protected]

Ernesto Ammendola, MD

Role: primary

[email protected]

Other Identifiers

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IMPLANTED

Identifier Type: -

Identifier Source: org_study_id

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