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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2011 by Medtronic Comercial Ltda..
Recruitment status was:  Enrolling by invitation
Sponsor:
ClinicalTrials.gov Identifier:
NCT01189630
First Posted: August 26, 2010
Last Update Posted: March 30, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Medtronic Comercial Ltda.
  Purpose

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.


Condition
Heart Failure

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Medtronic Observational Study in the "Real World" of Implantable Electronic Cardiac Devices

Further study details as provided by Medtronic Comercial Ltda.:

Estimated Enrollment: 3500
Study Start Date: December 2010
Estimated Study Completion Date: December 2015
Detailed Description:
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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 95 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients eligible to participate in this study are among those having an approved indication for the implantation of Implantable Cardiac Pacemakers (IPG), Cardiac Resynchronization Pacemakers (CRT-P), Implantable Cardioverter Defibrillator (ICD) with or without Cardiac Resynchronization Pacemakers (CRT-D).
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01189630


Locations
Brazil
Medtronic Comercial
São Paulo, SP, Brazil, 04534000
Sponsors and Collaborators
Medtronic Comercial Ltda.
Investigators
Study Director: Roberto Takeda, MD Medtronic Comercial
  More Information

Responsible Party: Roberto Takeda, Medtronic Comercial
ClinicalTrials.gov Identifier: NCT01189630     History of Changes
Other Study ID Numbers: MDT-01-2010
First Submitted: August 25, 2010
First Posted: August 26, 2010
Last Update Posted: March 30, 2011
Last Verified: March 2011

Keywords provided by Medtronic Comercial Ltda.:
"Real World" Electronic Database with clinical information
related to Implantable Cardiac devices.

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases