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

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.

Study Overview

• Status: Unknown
• Conditions: Heart Failure

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.

• Study Type: Observational
• Enrollment (Anticipated): 3500

Contacts and Locations

Study Locations

• Brazil
  • SP
    • São Paulo, SP, Brazil, 04534000
      • Medtronic Comercial

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 95 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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).

Description

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.

Study Plan

How is the study designed?

Collaborators and Investigators

• Sponsor: Medtronic Comercial Ltda.
• Investigators: Study Director: Roberto Takeda, MD, Medtronic Comercial

Study record dates

Study Major Dates

• Study Start: December 1, 2010
• Study Completion (Anticipated): December 1, 2015

Study Registration Dates

• First Submitted: August 25, 2010
• First Submitted That Met QC Criteria: August 25, 2010
• First Posted (Estimate): August 26, 2010

Study Record Updates

• Last Update Posted (Estimate): March 30, 2011
• Last Update Submitted That Met QC Criteria: March 29, 2011
• Last Verified: March 1, 2011

More Information

Terms related to this study

• Keywords: "Real World" Electronic Database with clinical information; related to Implantable Cardiac devices.
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: MDT-01-2010