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Medtronic Observational Study in the "Real World" of Implantable Electronic Cardiac Devices

NCT ID: NCT01189630

Last Updated: 2011-03-30

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

3500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-12-31

Study Completion Date

2015-12-31

Brief Summary

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The Observational Study in the "Real World" of Implantable Electronic Cardiac Devices will enable the construction of an electronic database with local access to clinical information, which will collect and disseminate epidemiologic data on demography, cardiovascular mortality and morbidity, and potential risk factors for a selected group of patients. These clinical variables will be analyzed against the data, as based in the programming of devices and the diagnostics. Approved descriptive statistics and analyses will be made available via Internet. The study will describe statistical indexes on sub-groups representing more than 10% of total of datasets.

The study will be open to include any patient that had a Medtronic electronic device implanted, pacemakers, ICD, ICD with CRP. The study will be also adapted for devices implanted in the present and for devices to be implanted in patients in the future.

Detailed Description

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This study is a Prospective, Multicenter Observational Post Market Release Study. It shall involve around 2,000 patients that are eligible for Implantable Cardiac Pacemakers (IPG) implantation, 500 patients eligible for Cardiac Resynchronization Pacemakers (CRT-P) implantation, 1,000 patients eligible for the implantation of Implantable Cardioverter Defibrillators with or without Cardiac Resynchronization Pacemakers (CDI, CRT-D), and around 20 centers in Brazil. Patients will be consecutively enrolled in centers among those selected for the implantation of a Medtronic device in accordance with indications approved.

Conditions

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Heart Failure

Keywords

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"Real World" Electronic Database with clinical information related to Implantable Cardiac devices.

Study Design

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Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Patients older than18 years of age
* Patient agrees to participate in the study and is able to sign the Data Release Form
* High probability of adherence to follow-up requirements

Exclusion Criteria

* Patients who want to be enrolled in another clinical study during at the same time that he/she is part of OBSERVE study.
Minimum Eligible Age

18 Years

Maximum Eligible Age

95 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medtronic Comercial Ltda.

INDUSTRY

Sponsor Role lead

Responsible Party

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Medtronic Comercial

Principal Investigators

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Roberto Takeda, MD

Role: STUDY_DIRECTOR

Medtronic Comercial

Locations

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Medtronic Comercial

São Paulo, São Paulo, Brazil

Site Status

Countries

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Brazil

Other Identifiers

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MDT-01-2010

Identifier Type: -

Identifier Source: org_study_id