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Home Monitoring for Atrial Fibrillation Using a Microlife Blood Pressure Monitor (TRIPPS)

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ClinicalTrials.gov Identifier: NCT00861354
Recruitment Status : Completed
First Posted : March 13, 2009
Last Update Posted : January 8, 2010
Sponsor:
Information provided by:
Microlife

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.

Condition or disease Intervention/treatment
Atrial Fibrillation Device: Microlife blood pressure monitor with AF detection (Microlife AFIB MLU3MQ1)

Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Home Monitoring for Atrial Fibrillation Using a Microlife Blood Pressure Monitor: Trial of Regular vs Irregualr Pulse for the Prevention of Stroke (TRIPPS 2.0)
Study Start Date : March 2009
Actual Primary Completion Date : September 2009
Actual Study Completion Date : September 2009

Resource links provided by the National Library of Medicine



Intervention Details:
  • Device: Microlife blood pressure monitor with AF detection (Microlife AFIB MLU3MQ1)
    Monitoring heart rhythm daily for 30 days using the blood pressure monitor and the ECG recorder.
    Other Name: Microlife AFIB MLU3MQ1


Primary Outcome Measures :
  1. Sensitivity and specificity of the blood pressure monitor used for detecting atrial fibrillation compared to the electrocardiogram. [ Time Frame: After final subject data is available. ]

Secondary Outcome Measures :
  1. Assess subjects understanding of the use of the device for atrial fibrillation. [ Time Frame: After final subject data is available. ]


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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients seen in a general medical practice.
Criteria

Inclusion Criteria: any of the following

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

Exclusion Criteria:

  • permanent pacemaker
  • impalantable defibrillator

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00861354


Locations
United States, New York
Joseph Wiesel, MD medical office
Flushing, New York, United States, 11355
Sponsors and Collaborators
Microlife
Investigators
Principal Investigator: Joseph Wiesel, MD

Responsible Party: Joseph Wiesel, MD, Microlife
ClinicalTrials.gov Identifier: NCT00861354     History of Changes
Other Study ID Numbers: tripps2
First Posted: March 13, 2009    Key Record Dates
Last Update Posted: January 8, 2010
Last Verified: January 2010

Keywords provided by Microlife:
atrial fibrillation
home blood pressure monitoring

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