Atrial FibrillationRecurrent AFNCT02898545
Recurrent Atrial Fibrillation
A study testing SEEQ monitor in people with Atrial Fibrillation, run by University of Cincinnati at 1 site in United States.
Trial summary
This study will evaluate the recurrence rates of atrial fibrillation that develops in the hospital following non cardiac procedures or surgeries or acute medical illnesses. 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?
- SEEQ monitor
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2016to 20 Jul 2017
- Phase
- Interventional
- 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
Who may be able to join
- Development of atrial fibrillation or flutter during a hospital stay following a non-cardiac procedure or acute medical illness
- CHADS2VASc score of 2 or more
Who cannot join
- Prior history of atrial fibrillation of flutter
- Requiring ventilator support or in shock
- Acute decompensated heart failure or EF =/< 40%
- Greater than mild valvular heart disease
- Other structural heart disease such as more than mild LVH, constrictive or restrictive cardiomyopathy
- Hyperthyroidism uncontrolled at the time of diagnosis if known
Show all 9Show fewer
- Pulmonary embolism that requires thrombolysis or resulted in shock
- Use of antiarrhythmic drugs (class I or III) at the time of discharge
- Cardiothoracic surgery in the last 6 months
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Cincinnati Medical Center
Cincinnati, Ohio, 45219
About this study
This study will evaluate the recurrence rates of atrial fibrillation that develops in the hospital following non cardiac procedures or surgeries or acute medical illnesses.
Read the detailed description
Eligible individuals with no previous history of atrial fibrillation or flutter who develop a limited episode of atrial fibrillation during a hospital stay for an acute medical illness or non-cardiothoracic surgery or procedure. Patients will be monitored for a period of 1 month using Medtronic SEEQ monitors for recurrence. Subjects will self assign to wear the SEEQ monitor or standard of care. Individuals with implanted cardiac devices capable of detecting atrial fibrillation will also be included.
- Conditions
- Atrial Fibrillation
- Being tested
- SEEQ monitor
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SEEQ monitorDevice
An external cardiac rhythm monitor
| Study group | Role | What they receive |
|---|---|---|
| SEEQ monitor | Other | Subjects will be monitored via use of the SEEQ monitor Receives: Device: SEEQ monitor |
| Standard of care | No intervention | Subjects will not wear the SEEQ monitor or may have a pre-existing implanted device capable of detecting atrial fibrillation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence of atrial fibrillation
The rate of recurrence of atrial fibrillation will be compared to the recurrence noted in the standard of care arm.
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2016 (estimated)
- Study startSep 2016
- Primary completion20 Jul 2017
- Study completion20 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by University of CincinnatiThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Cincinnati
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mehran Attari, University of Cincinnati
- Investigators
- Mehran Attari, MD, Principal investigator, University of Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02898545
- Sponsor's protocol ID
- 2015-2478
- Acronym
- Recurrent AF
- Status last verified
- Jul 2017
- First submitted
- 8 Sep 2016
- Last updated
- 1 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Recurrent Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT02898545
- Acronym / sponsor ID
- Recurrent AF / 2015-2478
- Conditions
- Atrial Fibrillation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- University of CincinnatiUniversity, hospital or other
- Study start
- Sep 2016
- Primary completion
- 20 Jul 2017 (actual)
- Study completion
- 20 Jul 2017 (actual)
- First posted
- 13 Sep 2016 (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.
This study will evaluate the recurrence rates of atrial fibrillation that develops in the hospital following non cardiac procedures or surgeries or acute medical illnesses.
Detailed description
Eligible individuals with no previous history of atrial fibrillation or flutter who develop a limited episode of atrial fibrillation during a hospital stay for an acute medical illness or non-cardiothoracic surgery or procedure. Patients will be monitored for a period of 1 month using Medtronic SEEQ monitors for recurrence. Subjects will self assign to wear the SEEQ monitor or standard of care. Individuals with implanted cardiac devices capable of detecting atrial fibrillation will also be included.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SEEQ monitor | Other | Device: SEEQ monitorSubjects will be monitored via use of the SEEQ monitor |
| Standard of care | No intervention | –Subjects will not wear the SEEQ monitor or may have a pre-existing implanted device capable of detecting atrial fibrillation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Development of atrial fibrillation or flutter during a hospital stay following a non-cardiac procedure or acute medical illness
- CHADS2VASc score of 2 or more
Key exclusion criteria (9 listed)
- Prior history of atrial fibrillation of flutter
- Requiring ventilator support or in shock
- Acute decompensated heart failure or EF =/< 40%
- Greater than mild valvular heart disease
- Other structural heart disease such as more than mild LVH, constrictive or restrictive cardiomyopathy
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 |
|---|---|---|
| SEEQ monitorAn external cardiac rhythm monitor | Device | SEEQ monitor |
Primary outcome
Recurrence of atrial fibrillation
Time frame: 28 days
The rate of recurrence of atrial fibrillation will be compared to the recurrence noted in the standard of care arm.
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 1 Aug 2017.
- Individual participant dataSharing planned: Undecided
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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.
Mehran Attari, MD principal investigator
University of Cincinnati
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SEEQ monitor in people with Atrial Fibrillation, run by University of Cincinnati 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 2 inclusion and 9 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 1 Aug 2017. 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?
Recurrence of atrial fibrillation (time frame: 28 days). It is what the study was designed to measure, not a finding.
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 1 Aug 2017.