Atrial FibrillationTRIPPSNCT00861354
Home Monitoring for Atrial Fibrillation Using a Microlife Blood Pressure Monitor
An observational study of Atrial Fibrillation, run by Microlife at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Microlife blood pressure monitor with AF detection (Microlife AFIB MLU3MQ1)
- Type of treatment
- Medical device
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2009to Sep 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients seen in a general medical practice.
Who may be able to join
- age 65 or older
- hypertension
- diabetes mellitus
- congestive heart failure
- previous stroke
Who cannot join
- permanent pacemaker
- impalantable defibrillator
Trial locations and contacts
1 site in 1 country.
United States1 site
Joseph Wiesel, MD medical office
Flushing, New York, 11355
About this study
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)
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.
- Conditions
- Atrial Fibrillation
- Being tested
- Microlife blood pressure monitor with AF detection (Microlife AFIB MLU3MQ1)
- Keywords
- atrial fibrillation, home blood pressure monitoring
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Microlife blood pressure monitor with AF detection (Microlife AFIB MLU3MQ1)Device
Also called Microlife AFIB MLU3MQ1
Monitoring heart rhythm daily for 30 days using the blood pressure monitor and the ECG recorder.
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and specificity of the blood pressure monitor used for detecting atrial fibrillation compared to the electrocardiogram.
Measured: After final subject data is available.
Secondary outcomes (1)
Assess subjects understanding of the use of the device for atrial fibrillation.
Measured: After final subject data is available.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2009 (estimated)
- Study startMar 2009
- Primary completionSep 2009
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Microlife
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Joseph Wiesel, MD, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00861354
- Sponsor's protocol ID
- tripps2
- Acronym
- TRIPPS
- Status last verified
- Jan 2010
- First submitted
- 10 Mar 2009
- Last updated
- 8 Jan 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT00861354
- Acronym / sponsor ID
- TRIPPS / tripps2
- Conditions
- Atrial Fibrillation
- Keywords
- atrial fibrillation, home blood pressure monitoring
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- MicrolifeIndustry (pharma, biotech, devices)
- Study start
- Mar 2009
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 13 Mar 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients seen in a general medical practice.
Key inclusion criteria (5 listed)
- age 65 or older
- hypertension
- diabetes mellitus
- congestive heart failure
- previous stroke
Key exclusion criteria (2 listed)
- permanent pacemaker
- impalantable defibrillator
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Microlife blood pressure monitor with AF detection (Microlife AFIB MLU3MQ1)Also: Microlife AFIB MLU3MQ1Monitoring heart rhythm daily for 30 days using the blood pressure monitor and the ECG recorder. | Device | – |
Primary outcome
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.
1 secondary outcome
Assess subjects understanding of the use of the device for atrial fibrillation.
Time frame: After final subject data is available.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2010.
Related trials for Atrial Fibrillation
Active, not recruiting
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
Concomitant Procedures, Atrial Fibrillation
Active, not recruiting
CONVERGE Post-Approval Study (PAS)
Chronic Atrial Fibrillation
Recruiting
Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
Ischemic Stroke, Atrial Fibrillation
RecruitingPhase 2
Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
Atrial Fibrillation (AF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joseph Wiesel, MD principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation, run by Microlife at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jan 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2010.