PacemakerNCT00294034
VIBRANT Registry: Value of Information Based From Pacemaker Recordings and New Technologies
An observational study of Pacemaker and Bradycardia, run by Medtronic Cardiac Rhythm and Heart Failure at 27 sites in United States.
Trial summary
The purpose of this study is to collect data from pacemakers and determine how this information is used by physicians to care for their patients with pacemakers. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pacemaker, Bradycardia
- What is being tested?
- Pacemaker
- Type of treatment
- Medical device
- How many people
- 950 participants
- Where
- 27 sitesUnited States
- Study dates
- Oct 2002to May 2006
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Class I or Class II indication for dual chamber pacing
Who cannot join
- Has an ICD or is a known candidate for an ICD
Trial locations and contacts
27 sites in 1 country.
27 sites in 1 country
United States27 sites
Study site
Arlington, Texas
Study site
Austin, Texas
Study site
Barberton, Ohio
Study site
Bay Shore, New York
Study site
Beaumont, Texas
Study site
Bismarck, North Dakota
Study site
Chicago, Illinois
Study site
Cincinnati, Ohio
Study site
Columbia, South Carolina
Study site
Edgewood, Kentucky
Study site
Fort Lauderdale, Florida
Study site
Hot Springs, Arkansas
Study site
Hyannis, Massachusetts
Study site
Lansing, Michigan
Study site
Largo, Florida
Study site
Little Rock, Arkansas
Study site
Louisville, Kentucky
Study site
Marion, Ohio
Study site
Massillon, Ohio
Study site
McKinney, Texas
Study site
Middletown, Ohio
Study site
North Little Rock, Arkansas
Study site
Ormond Beach, Florida
Study site
Pittsburgh, Pennsylvania
Study site
St. Petersburg, Florida
Study site
Syracuse, New York
Study site
Waukesha, Wisconsin
About this study
The purpose of this study is to collect data from pacemakers and determine how this information is used by physicians to care for their patients with pacemakers.
Read the detailed description
The purpose of this registry is to gain a better understanding of how diagnostic capabilities in four Vitatron pacemakers (Selection AFm, Clarity, C-Series, and T-Series) are being utilized for the clinical management of a general pacing population. Pacemaker information and health status is collected from all patients enrolled.
- Conditions
- Pacemaker, Bradycardia
- Being tested
- Pacemaker
- Keywords
- Registry, Pacemaker, Diagnostics
- Medical subject headings
- Bradycardia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PacemakerDevice
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2006 (estimated)
- Study startOct 2002
- Study completionMay 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PacemakerStudies of the same condition, open and under way.
- More trials run by Medtronic Cardiac Rhythm and Heart FailureThe sponsor's other registered studies.
- 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
- Observational model
- Defined population
- Time perspective
- Prospective
- Enrolment
- 950 participants
Sponsor and investigators
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Medtronic, Medtronic BRC
- Investigators
- Norman Jaffe, MD, Principal investigator, Onondaga Hill Cardiovascular GroupLuis Caceres, MD, Principal investigator, Prairie Cardiovascular Consultants
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00294034
- Sponsor's protocol ID
- 197
- Status last verified
- Mar 2007
- First submitted
- 16 Feb 2006
- Last updated
- 27 Mar 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VIBRANT Registry: Value of Information Based From Pacemaker Recordings and New Technologies
- ClinicalTrials.gov ID
- NCT00294034
- Acronym / sponsor ID
- 197
- Conditions
- Pacemaker, Bradycardia
- Keywords
- Registry, Pacemaker, Diagnostics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 950 participants
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart FailureIndustry (pharma, biotech, devices)
- Collaborators
- Medtronic, Medtronic BRC
- Study start
- Oct 2002
- Study completion
- May 2006 (actual)
- First posted
- 20 Feb 2006 (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 purpose of this study is to collect data from pacemakers and determine how this information is used by physicians to care for their patients with pacemakers.
Detailed description
The purpose of this registry is to gain a better understanding of how diagnostic capabilities in four Vitatron pacemakers (Selection AFm, Clarity, C-Series, and T-Series) are being utilized for the clinical management of a general pacing population. Pacemaker information and health status is collected from all patients enrolled.
Study design
- Observational model
- Defined population
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Class I or Class II indication for dual chamber pacing
Key exclusion criteria (1 listed)
- Has an ICD or is a known candidate for an ICD
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pacemaker | Device | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2007.
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Heart Failure
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.
Norman Jaffe, MD principal investigator
Onondaga Hill Cardiovascular Group
Luis Caceres, MD principal investigator
Prairie Cardiovascular Consultants
27 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pacemaker and Bradycardia, run by Medtronic Cardiac Rhythm and Heart Failure at 27 sites in United States.
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 1 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: finished, as of the sponsor's last update on 27 Mar 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 sites in United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 27 Mar 2007.