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

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.
 
ClinicalTrials.gov Identifier: NCT01189630
Recruitment Status : Unknown
Verified March 2011 by Medtronic Comercial Ltda..
Recruitment status was:  Enrolling by invitation
First Posted : August 26, 2010
Last Update Posted : March 30, 2011
Sponsor:
Information provided by:
Medtronic Comercial Ltda.

Tracking Information
First Submitted Date August 25, 2010
First Posted Date August 26, 2010
Last Update Posted Date March 30, 2011
Study Start Date December 2010
Primary Completion Date Not Provided
Current Primary Outcome Measures Not Provided
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
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.
Study Type Observational
Study Design Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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).
Condition Heart Failure
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: August¬†25,¬†2010)
3500
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2015
Primary Completion Date Not Provided
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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 95 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Brazil
Removed Location Countries  
 
Administrative Information
NCT Number NCT01189630
Other Study ID Numbers MDT-01-2010
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Roberto Takeda, Medtronic Comercial
Study Sponsor Medtronic Comercial Ltda.
Collaborators Not Provided
Investigators
Study Director: Roberto Takeda, MD Medtronic Comercial
PRS Account Medtronic Comercial Ltda.
Verification Date March 2011