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

Heart Failure Clinical Trial

— OBSERVE  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT01189630
• Other study ID #: MDT-01-2010
• Status: Enrolling by invitation
• Phase: N/A
• First received: August 25, 2010
• Last updated: March 29, 2011
• Start date: December 2010
• Est. completion date: December 2015

Study information

• Verified date: March 2011
• Source: Medtronic Comercial Ltda.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Health Surveillance Agency
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 3500
• Est. completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 95 Years

Eligibility

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 Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Heart Failure

Locations

Country	Name	City	State
Brazil	Medtronic Comercial	São Paulo	SP

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Comercial Ltda.

Country where clinical trial is conducted

Brazil,