Heart FailureOBSERVENCT01189630
Medtronic Observational Study in the "Real World" of Implantable Electronic Cardiac Devices
An observational study of Heart Failure, run by Medtronic Comercial Ltda. at 1 site in Brazil.
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… Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Heart Failure
- How many people
- 3,500 participants
- Where
- 1 siteBrazil
- Study dates
- Dec 2010to Dec 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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).
Who may be able to join
- 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
Who cannot join
- Patients who want to be enrolled in another clinical study during at the same time that he/she is part of OBSERVE study.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Heart Failure
- Keywords
- "Real World" Electronic Database with clinical information, related to Implantable Cardiac devices.
- Medical subject headings
- Heart Failure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2010 (estimated)
- Study startDec 2010
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 3,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medtronic Comercial Ltda.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Roberto Takeda, MD, Study director, Medtronic Comercial
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01189630
- Sponsor's protocol ID
- MDT-01-2010
- Acronym
- OBSERVE
- Status last verified
- Mar 2011
- First submitted
- 25 Aug 2010
- Last updated
- 30 Mar 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medtronic Observational Study in the "Real World" of Implantable Electronic Cardiac Devices
- ClinicalTrials.gov ID
- NCT01189630
- Acronym / sponsor ID
- OBSERVE / MDT-01-2010
- Conditions
- Heart Failure
- Keywords
- "Real World" Electronic Database with clinical information, related to Implantable Cardiac devices.
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 3,500 participants (estimated)
- Lead sponsor
- Medtronic Comercial Ltda.Industry (pharma, biotech, devices)
- Study start
- Dec 2010
- Study completion
- Dec 2015 (estimated)
- First posted
- 26 Aug 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Patients who want to be enrolled in another clinical study during at the same time that he/she is part of OBSERVE study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roberto Takeda, MD study director
Medtronic Comercial
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure, run by Medtronic Comercial Ltda. at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Mar 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2011; AzTrials last refreshed its copy on 7 Nov 2026.