Atrial Fibrillation Rate Control Therapy Guided By Continuous Ambulatory Monitoring
Recruitment status was Active, not recruiting
|First Received Date ICMJE||June 26, 2005|
|Last Updated Date||September 6, 2006|
|Start Date ICMJE||April 2005|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
||Time to adequate heart rate (HR) control, defined as resting heart rate ≤ 80 bpm and average heart rate over 24 hours < 100 and no recorded HR > 110% of maximum age-adjusted predicted HR.|
|Original Primary Outcome Measures ICMJE||Same as current|
|Change History||Complete list of historical versions of study NCT00115843 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE
||Total health care costs associated with conventional and Cardionet based monitoring strategy.|
|Original Secondary Outcome Measures ICMJE||Same as current|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Atrial Fibrillation Rate Control Therapy Guided By Continuous Ambulatory Monitoring|
|Official Title ICMJE||Atrial Fibrillation Rate Control Therapy Guided By Continuous Ambulatory Monitoring|
The purpose of this study is to demonstrate that the use of a continuous ambulatory monitoring device will reduce both the time to effective rate control and the health care expenditures associated with standard methods of rate control monitoring in patients presenting with atrial fibrillation with a rapid heart rate.
This is an open, randomized controlled trial to compare a standard rate-control strategy with one using the Cardionet device to guide therapy for the management of atrial fibrillation. Patients presenting to an outpatient clinic or to the Emergency Department with atrial fibrillation with a ventricular rate greater than 100 bpm at rest will be enrolled.
Patients will be prescribed either a beta blocker or a calcium channel blocker, or have their baseline dose increased if already taking one of these agents at the discretion of the treating physician. This is consistent with standard outpatient treatment guidelines for rate control in atrial fibrillation.
At the time of enrollment, patients will be randomized to a standard rate control protocol or a rate-control protocol guided by the Cardionet device.
Standard Care (Comparison Group):
Patients randomized to standard care will have a home patient educator install the Cardionet device within 24 hours after enrollment. The Cardionet device will be used to adjudicate the primary endpoint of adequate rate control in the standard care group. The patient’s treating physician will be blinded to the reports from the Cardionet device. These patients will have another office visit with the initial referring physician or a staff cardiologist within the first week after enrollment and weekly thereafter. At this time, adequacy of rate control will be assessed by a standard 12-lead electrocardiogram and patient history. Medication will be adjusted per protocol. The patient will be seen on a weekly basis until adequate rate control is thought to have been achieved.
Rate Control using Cardionet (Study Group):
Patients randomized to use of the Cardionet device will have a home patient educator install the device within 24 hours after enrollment. Electrocardiographic summaries will be reviewed by a research physician three times a week and treatment decisions will be made based on a summary of 24-hour rate control. The physician will contact the patient by telephone and make medication adjustments per protocol. Three-times-weekly transmissions and medication adjustments will continue until adequate rate control is achieved over a period of 24 hours.
|Study Type ICMJE||Interventional|
|Study Phase||Not Provided|
|Study Design ICMJE||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Condition ICMJE||Atrial Fibrillation|
|Intervention ICMJE||Device: Mobile Cardiac Outpatient Telemetry|
|Study Arm (s)||Not Provided|
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Active, not recruiting|
|Completion Date||August 2006|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Location Countries ICMJE||United States|
|NCT Number ICMJE||NCT00115843|
|Other Study ID Numbers ICMJE||2004-P-000346|
|Has Data Monitoring Committee||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||Beth Israel Deaconess Medical Center|
|Information Provided By||Beth Israel Deaconess Medical Center|
|Verification Date||September 2006|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP