Atrial Fibrillation Rate Control Therapy Guided By Continuous Ambulatory Monitoring

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2006 by Beth Israel Deaconess Medical Center.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Cardionet
Information provided by:
Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier:
NCT00115843
First received: June 26, 2005
Last updated: September 6, 2006
Last verified: September 2006
  Purpose

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.


Condition Intervention
Atrial Fibrillation
Device: Mobile Cardiac Outpatient Telemetry

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Atrial Fibrillation Rate Control Therapy Guided By Continuous Ambulatory Monitoring

Resource links provided by NLM:


Further study details as provided by Beth Israel Deaconess Medical Center:

Primary Outcome Measures:
  • 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.

Secondary Outcome Measures:
  • Total health care costs associated with conventional and Cardionet based monitoring strategy.

Estimated Enrollment: 45
Study Start Date: April 2005
Estimated Study Completion Date: August 2006
Detailed Description:

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.

Treatment:

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.

Randomization:

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Atrial fibrillation with resting ventricular rate > 100 with rate control strategy indicated
  • Atrial fibrillation is likely to be recurrent or persistent in the clinical judgment of the physician
  • Patient able to be managed out of the hospital
  • Ability to sign informed consent
  • Ability to wear electrodes for the Cardionet device
  • Patient willing to have home patient educator install Cardionet monitor in their home

Exclusion Criteria:

  • Inability to follow up with prescribed schedule of monitoring
  • Concomitant use of antiarrhythmic drug
  • Indication for hospitalization
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00115843

Locations
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
Cardionet
Investigators
Principal Investigator: Peter Zimetbaum, MD Beth Israel Deaconess Medical Center
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00115843     History of Changes
Other Study ID Numbers: 2004-P-000346
Study First Received: June 26, 2005
Last Updated: September 6, 2006
Health Authority: United States: Institutional Review Board

Keywords provided by Beth Israel Deaconess Medical Center:
Atrial fibrillation
Arrhythmia
Tachycardia

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on August 25, 2014