NCT00115843

Brief Summary

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Apr 2005

Shorter than P25 for not_applicable atrial-fibrillation

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2005

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 26, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 27, 2005

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2006

Completed
Last Updated

April 5, 2017

Status Verified

April 1, 2017

Enrollment Period

1.4 years

First QC Date

June 26, 2005

Last Update Submit

April 4, 2017

Conditions

Atrial Fibrillation

Keywords

Atrial fibrillationArrhythmiaTachycardia

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Total health care costs associated with conventional and Cardionet based monitoring strategy.

Interventions

Mobile Cardiac Outpatient TelemetryDEVICE

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Inability to follow up with prescribed schedule of monitoring
  • Concomitant use of antiarrhythmic drug
  • Indication for hospitalization

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Atrial FibrillationArrhythmias, CardiacTachycardia

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsCardiac Conduction System Disease

Study Officials

  • Peter Zimetbaum, MD

    Beth Israel Deaconess Medical Center

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Richard A. and Susan F. Smith Professor of Medicine in the Field of Cardiovascular Medicine

Study Record Dates

First Submitted

June 26, 2005

First Posted

June 27, 2005

Study Start

April 1, 2005

Primary Completion

September 1, 2006

Study Completion

September 1, 2006

Last Updated

April 5, 2017

Record last verified: 2017-04

Locations

US(1)