Atrial FibrillationRATENCT00837798
RATE Registry - Registry of Atrial Tachyarrhythmia/Atrial Fibrillation (AT/AF) Episodes in the Cardiac Rhythm Management (CRM) Device Population
An observational study of Atrial Fibrillation, run by Abbott Medical Devices at 1 site in United States.
Trial summary
The purpose of this registry is to produce a prospective, outcome-oriented registry to document the prevalence of AT/AF in the CRM population by using the Advanced AT/AF Diagnostics in select SJM devices. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- CRM Device
- Type of treatment
- Medical device
- How many people
- 5,379 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2006to Apr 2012
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with a CRM device
Who may be able to join
- Patient is implanted with a CRM device
- Patient has no documented history of AF (3 months prior to enrollment)
- Patient is >18 years of age
- Patient has life expectancy of >24 months
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Registry of AT/AF Episodes in the CRM Device Population: RATE Registry
The purpose of this registry is to produce a prospective, outcome-oriented registry to document the prevalence of AT/AF in the CRM population by using the Advanced AT/AF Diagnostics in select SJM devices.
- Conditions
- Atrial Fibrillation
- Being tested
- CRM Device
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CRM DeviceDevice
Pacemaker, ICD, or CRT device
| Study group | Role | What they receive |
|---|---|---|
| No history of AF | Patient should not have had a documented history of AF for a period of 3 months prior to enrollment. Receives: Device: CRM Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of atrial tachycardia and atrial fibrillation in a cardiac rhythm management population
Measured: 24 months
Secondary outcomes (3)
Development or exacerbation of HF
Measured: 2 years
Development of AF
Measured: 2 years
AT/AF burden
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2009 (estimated)
- Study startOct 2006
- Primary completionApr 2012
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Abbott Medical DevicesThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 5,379 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Albert Waldo, MD, Study chair, University Hospitals Cleveland Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00837798
- Sponsor's protocol ID
- 374
- Acronym
- RATE
- Status last verified
- Feb 2019
- First submitted
- 4 Feb 2009
- Last updated
- 4 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Orlov MV, Olshansky B, Benditt DG, Kotler G, McIntyre T, Fujian Qu, Turkel M, Gorev M, Poghosyan H, Waldo AL. Is competitive atrial pacing a possible trigger for atrial fibrillation? Observations from the RATE registry. Heart Rhythm. 2021 Jan;18(1):3-9. doi: 10.1016/j.hrthm.2020.07.028. Epub 2020 Jul 30.
PubMed 32738404Swiryn S, Orlov MV, Benditt DG, DiMarco JP, Lloyd-Jones DM, Karst E, Qu F, Slawsky MT, Turkel M, Waldo AL; RATE Registry Investigators. Clinical Implications of Brief Device-Detected Atrial Tachyarrhythmias in a Cardiac Rhythm Management Device Population: Results from the Registry of Atrial Tachycardia and Atrial Fibrillation Episodes. Circulation. 2016 Oct 18;134(16):1130-1140. doi: 10.1161/CIRCULATIONAHA.115.020252.
PubMed 27754946
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Registry of AT/AF Episodes in the CRM Device Population: RATE Registry
- ClinicalTrials.gov ID
- NCT00837798
- Acronym / sponsor ID
- RATE / 374
- Conditions
- Atrial Fibrillation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5,379 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- Oct 2006
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 5 Feb 2009 (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 registry is to produce a prospective, outcome-oriented registry to document the prevalence of AT/AF in the CRM population by using the Advanced AT/AF Diagnostics in select SJM devices.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| No history of AF | – | Device: CRM DevicePatient should not have had a documented history of AF for a period of 3 months prior to enrollment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with a CRM device
Key inclusion criteria (4 listed)
- Patient is implanted with a CRM device
- Patient has no documented history of AF (3 months prior to enrollment)
- Patient is >18 years of age
- Patient has life expectancy of >24 months
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| CRM DevicePacemaker, ICD, or CRT device | Device | No history of AF |
Primary outcome
Prevalence of atrial tachycardia and atrial fibrillation in a cardiac rhythm management population
Time frame: 24 months
3 secondary outcomes
Development or exacerbation of HF
Time frame: 2 years
Development of AF
Time frame: 2 years
AT/AF burden
Time frame: 2 years
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 4 Feb 2019.
- Derived from this study: PubMed 32738404Orlov MV, Olshansky B, Benditt DG, Kotler G, McIntyre T, Fujian Qu, Turkel M, Gorev M, Poghosyan H, Waldo AL. Is competitive atrial pacing a possible trigger for atrial fibrillation? Observations from the RATE registry. Heart Rhythm. 2021 Jan;18(1):3-9. doi: 10.1016/j.hrthm.2020.07.028. Epub 2020 Jul 30.
- Derived from this study: PubMed 27754946Swiryn S, Orlov MV, Benditt DG, DiMarco JP, Lloyd-Jones DM, Karst E, Qu F, Slawsky MT, Turkel M, Waldo AL; RATE Registry Investigators. Clinical Implications of Brief Device-Detected Atrial Tachyarrhythmias in a Cardiac Rhythm Management Device Population: Results from the Registry of Atrial Tachycardia and Atrial Fibrillation Episodes. Circulation. 2016 Oct 18;134(16):1130-1140. doi: 10.1161/CIRCULATIONAHA.115.020252.
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Atrial Fibrillation (AF)
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.
Albert Waldo, MD study chair
University Hospitals Cleveland Medical Center
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 Atrial Fibrillation, run by Abbott Medical Devices at 1 site 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 4 inclusion and 0 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 4 Feb 2019. 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 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.
What does the primary outcome measure?
Prevalence of atrial tachycardia and atrial fibrillation in a cardiac rhythm management population (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00837798, which also lists 2 linked publications.
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 4 Feb 2019.