Clinical trial NCT01189630: Medtronic Observational Study in the "Real World" of Implantable Electronic Cardiac Devices
Official title: Medtronic Observational Study in the "Real World" of Implantable Electronic Cardiac Devices
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Heart Failure
Keywords: "Real World" Electronic Database with clinical information
related to Implantable Cardiac devices.
Lead sponsor: Medtronic Comercial Ltda.
Sponsor class: INDUSTRY
First posted: 2010-08-26
Enrollment: 3500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
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).

Brief 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.

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 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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Medtronic Comercial
state: SP
Study officials:
affiliation: Medtronic Comercial
name: Roberto Takeda, MD
role: STUDY_DIRECTOR
References: