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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
Medtronic Comercial Ltda.
ClinicalTrials.gov Identifier:
NCT01189630
First received: August 25, 2010
Last updated: March 29, 2011
Last verified: March 2011
  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

Resource links provided by NLM:


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

Ages Eligible for Study:   18 Years to 95 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Roberto Takeda, Medtronic Comercial
ClinicalTrials.gov Identifier: NCT01189630     History of Changes
Other Study ID Numbers: MDT-01-2010
Study First Received: August 25, 2010
Last Updated: March 29, 2011
Health Authority: Brazil: National Health Surveillance Agency

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

ClinicalTrials.gov processed this record on April 17, 2014