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

This study has been completed.
Sponsor:
Information provided by:
Microlife
ClinicalTrials.gov Identifier:
NCT00861354
First received: March 10, 2009
Last updated: January 6, 2010
Last verified: January 2010
  Purpose

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 Intervention
Atrial Fibrillation
Device: Microlife blood pressure monitor with AF detection (Microlife AFIB MLU3MQ1)

Study Type: Observational
Study Design: 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)

Resource links provided by NLM:


Further study details as provided by Microlife:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Assess subjects understanding of the use of the device for atrial fibrillation. [ Time Frame: After final subject data is available. ] [ Designated as safety issue: No ]

Estimated Enrollment: 150
Study Start Date: March 2009
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
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
  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Joseph Wiesel, MD, Microlife
ClinicalTrials.gov Identifier: NCT00861354     History of Changes
Other Study ID Numbers: tripps2
Study First Received: March 10, 2009
Last Updated: January 6, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Microlife:
atrial fibrillation
home blood pressure monitoring

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

ClinicalTrials.gov processed this record on April 16, 2014