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
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: 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
Cardiovascular Diseases
Heart Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on October 21, 2014