Atrial FibrillationNCT00863382
Comparison of External Event Recorders for Atrial Fibrillation Monitoring
A study testing Standard Event Monitor and Sleuth Monitor in people with Atrial Fibrillation, run by Dhanunjaya Lakkireddy, MD, FACC at 1 site in United States.
Trial summary
Ablation of atrial fibrillation is a well established treatment method to restore normal sinus rhythm and eliminate the need for continued antiarrhythmic therapy and anticoagulation. 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?
- Standard Event Monitor and Sleuth Monitor
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2009to Jan 2012
- 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
- All subjects who undergo radiofrequency ablation of paroxysmal AF.
Who cannot join
- Subjects with known allergy to sticky patches of event monitor
- Subjects with skin infection or other problems on the chest that interferes with monitor implantation
- Subjects who are scheduled for radiation therapy
- Subjects who are scheduled for therapeutic ultrasound (like lithotripsy)
- Subjects who are scheduled for MRI
- Subjects who are scheduled for a procedure that uses diathermy.
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- Subjects, in the opinion of the investigator, are not suitable candidates for the study
- Subjects that do not have analog telephone line at home.
- Existing Cardiac Rhythm Management Device (e.g., pacemaker or ICD)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kansas Medical Center
Kansas City, Kansas, 66160
About this study
Official title: Comparison of External Event Recorders With Implantable Monitor for Post Atrial Fibrillation Monitoring: Assessment of Cost and Efficacy
Ablation of atrial fibrillation is a well established treatment method to restore normal sinus rhythm and eliminate the need for continued antiarrhythmic therapy and anticoagulation. Absence of symptomatic and asymptomatic atrial fibrillation should be considered necessary for discontinuation of anticoagulation therapy. Presently, recurrence of atrial fibrillation is usually determined with the use of a non looping event monitor which is typically used by the subject at the time of symptomatic arrhythmia. This method does not detect asymptomatic atrial fibrillation. Random asymptomatic recording can be added, but the chance for detecting recurrence of arrhythmia is not great. Too frequently, the success rates of AF ablation procedures are inflated by insufficient follow up and patient's limited compliance in reporting and recording episodes of recurrent arrhythmias. Often times, it is very inconvenient for patients to wear external event recorders. Allergies to the sticky pads that are needed for most of the external monitoring devices continues to be a problem. Implantable loop recorders have the advantage of detecting symptomatic and asymptomatic atrial fibrillation continuously. They also offer the convenience of monitoring for up to 18 to 24 months without significant patient discomfort. However, implantation and explantation of these devices involves a limited surgical procedure as well as considerable experience. In this study we attempt to assess the differences in these two types of monitoring systems in assessing the long term efficacy of AF ablation.
- Conditions
- Atrial Fibrillation
- Being tested
- Standard Event Monitor, Sleuth Monitor
- Keywords
- atrial fibrillation
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Event MonitorDevice
Standard Event Monitor
Sleuth MonitorDevice
Implantable Sleuth Recorder
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Standard Event Monitor Receives: Device: Standard Event Monitor |
| 2 | Active comparator | Sleuth recorder Receives: Device: Sleuth Monitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
recurrence of atrial fibrillation
Measured: 6 months, 1 year, 2 years
Secondary outcomes (4)
cost-effectiveness ratio (ICER) between the two technologies and the 95% confidence interval for the ICER
Measured: 6 months, 1 year, 2 years
percentage of patients whose Coumadin is stopped prematurely due to inappropriate assumption of rhythm control
Measured: 6 months, 1 year, 2 years
percentage of patients who develop symptoms of stroke or transient ischemic attacks during follow up
Measured: 6 months, 1 year, 2 years
cost differences in follow up care between the two groups
Measured: 6 months, 1 year, 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2009 (estimated)
- Study startJan 2009
- Primary completionJan 2011 (estimated)
- Study completionJan 2012 (estimated)
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.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dhanunjaya Lakkireddy, MD, FACC
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dhanunjaya Lakkireddy, MD, FACC, University of Kansas Medical Center
- Investigators
- Dhanunjuya Lakkireddy, MD, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00863382
- Sponsor's protocol ID
- 11566
- Status last verified
- May 2012
- First submitted
- 16 Mar 2009
- Last updated
- 7 May 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of External Event Recorders With Implantable Monitor for Post Atrial Fibrillation Monitoring: Assessment of Cost and Efficacy
- ClinicalTrials.gov ID
- NCT00863382
- Acronym / sponsor ID
- 11566
- Conditions
- Atrial Fibrillation
- Keywords
- atrial fibrillation
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Dhanunjaya Lakkireddy, MD, FACCUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Jan 2011 (estimated)
- Study completion
- Jan 2012 (estimated)
- First posted
- 18 Mar 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.
Ablation of atrial fibrillation is a well established treatment method to restore normal sinus rhythm and eliminate the need for continued antiarrhythmic therapy and anticoagulation. Absence of symptomatic and asymptomatic atrial fibrillation should be considered necessary for discontinuation of anticoagulation therapy. Presently, recurrence of atrial fibrillation is usually determined with the use of a non looping event monitor which is typically used by the subject at the time of symptomatic arrhythmia. This method does not detect asymptomatic atrial fibrillation. Random asymptomatic recording can be added, but the chance for detecting recurrence of arrhythmia is not great. Too frequently, the success rates of AF ablation procedures are inflated by insufficient follow up and patient's limited compliance in reporting and recording episodes of recurrent arrhythmias. Often times, it is very inconvenient for patients to wear external event recorders. Allergies to the sticky pads that are needed for most of the external monitoring devices continues to be a problem. Implantable loop recorders have the advantage of detecting symptomatic and asymptomatic atrial fibrillation continuously. They also offer the convenience of monitoring for up to 18 to 24 months without significant patient discomfort. However, implantation and explantation of these devices involves a limited surgical procedure as well as considerable experience. In this study we attempt to assess the differences in these two types of monitoring systems in assessing the long term efficacy of AF ablation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Device: Standard Event MonitorStandard Event Monitor |
| 2 | Active comparator | Device: Sleuth MonitorSleuth recorder |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All subjects who undergo radiofrequency ablation of paroxysmal AF.
Key exclusion criteria (9 listed)
- Subjects with known allergy to sticky patches of event monitor
- Subjects with skin infection or other problems on the chest that interferes with monitor implantation
- Subjects who are scheduled for radiation therapy
- Subjects who are scheduled for therapeutic ultrasound (like lithotripsy)
- Subjects who are scheduled for MRI
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 |
|---|---|---|
| Standard Event MonitorStandard Event Monitor | Device | 1 |
| Sleuth MonitorImplantable Sleuth Recorder | Device | 2 |
Primary outcome
recurrence of atrial fibrillation
Time frame: 6 months, 1 year, 2 years
4 secondary outcomes
cost-effectiveness ratio (ICER) between the two technologies and the 95% confidence interval for the ICER
Time frame: 6 months, 1 year, 2 years
percentage of patients whose Coumadin is stopped prematurely due to inappropriate assumption of rhythm control
Time frame: 6 months, 1 year, 2 years
percentage of patients who develop symptoms of stroke or transient ischemic attacks during follow up
Time frame: 6 months, 1 year, 2 years
cost differences in follow up care between the two groups
Time frame: 6 months, 1 year, 2 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2012.
Related trials for Atrial Fibrillation
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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.
Dhanunjuya Lakkireddy, MD principal investigator
University of Kansas Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard Event Monitor and Sleuth Monitor in people with Atrial Fibrillation, run by Dhanunjaya Lakkireddy, MD, FACC 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 1 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: withdrawn, as of the sponsor's last update on 7 May 2012. 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 was withdrawn before enrolling participants, so there are no results.
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: 6 months, 1 year, 2 years). 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 7 May 2012.