NCT00861354

Brief Summary

This study assess the accuracy of a blood pressure monitor designed to detect atrial fibrillation. Subjects use the blood pressure monitor on a daily basis for 30 days and compare the readings to an ECG done at the same time.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2009

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

March 1, 2009

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

March 10, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 13, 2009

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
Last Updated

January 8, 2010

Status Verified

January 1, 2010

Enrollment Period

6 months

First QC Date

March 10, 2009

Last Update Submit

January 6, 2010

Conditions

Atrial Fibrillation

Keywords

atrial fibrillationhome blood pressure monitoring

Outcome Measures

Primary Outcomes (1)

  • Sensitivity and specificity of the blood pressure monitor used for detecting atrial fibrillation compared to the electrocardiogram.

    After final subject data is available.

Secondary Outcomes (1)

  • Assess subjects understanding of the use of the device for atrial fibrillation.

    After final subject data is available.

Interventions

Microlife blood pressure monitor with AF detection (Microlife AFIB MLU3MQ1)DEVICE

Monitoring heart rhythm daily for 30 days using the blood pressure monitor and the ECG recorder.

Also known as: Microlife AFIB MLU3MQ1

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients seen in a general medical practice.

You may qualify if:

  • age 65 or older
  • hypertension
  • diabetes mellitus
  • congestive heart failure
  • previous stroke

You may not qualify if:

  • permanent pacemaker
  • impalantable defibrillator

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Joseph Wiesel, MD medical office

Flushing, New York, 11355, United States

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Joseph Wiesel, MD

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 10, 2009

First Posted

March 13, 2009

Study Start

March 1, 2009

Primary Completion

September 1, 2009

Study Completion

September 1, 2009

Last Updated

January 8, 2010

Record last verified: 2010-01

Locations

US(1)