Atrial Fibrillation (AF)OMRON-AFNCT07582523
Out-of-office Monitoring for Rhythms Of Normal Versus Atrial Fibrillation
A study testing Blood Pressure Monitor Without AFib Detection and Blood Pressure Monitor With AFib Detection in people with Atrial Fibrillation (AF) and Hypertension (HTN), run by University of California, San Francisco at 1 site in United States.
Trial summary
The goal of this clinical trial is to learn if screening for atrial fibrillation (AFib), a common irregular heart rhythm, through daily home blood pressure monitoring will decrease the time to atrial fibrillation diagnosis in older adults with hypertension. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Atrial Fibrillation (AF), Hypertension (HTN), High Blood Pressure
- What is being tested?
- Blood Pressure Monitor Without AFib Detection and Blood Pressure Monitor With AFib Detection
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,910 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2026to Apr 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hypertensive patients aged 60 years or older living in the United States who meet at least one of the following criteria:
- ≥70 years old
- BMI ≥30kg/m2
- CHA2DS2-VASc ≥3 (excluding Female sex)
Who cannot join
- Current or prior diagnosis of atrial fibrillation (AFib), atrial flutter, or atrial tachycardia
- Receiving anticoagulation therapy
- History of skin allergies to adhesive patches
- Open wound or skin inflammation, such as eczema, in the chest region.
- Inability to wear the patch ECG monitor or apply the monitor by herself/himself or with the help of a caregiver
- Individuals who are currently using home medical devices or wearable devices capable of detecting atrial fibrillation and are unwilling to refrain from using such AF detection device features during the randomized controlled trial (RCT) phase of the study
- People who have a mailing address in Alaska, Hawaii, or a U.S. territory
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
UCSF Medical Center at Parnassus
San Francisco, California, 94143
About this study
The goal of this clinical trial is to learn if screening for atrial fibrillation (AFib), a common irregular heart rhythm, through daily home blood pressure monitoring will decrease the time to atrial fibrillation diagnosis in older adults with hypertension. The main question it aims to answer is:
-- Does introducing screening for AFib using a blood pressure monitor with AFib detection technology decrease time to AFib diagnosis in patients with high blood pressure, compared to usual care using a conventional home blood pressure monitor with no AFib detection?
Read more
Participants will participate in two phases of the study: (1) clinical trial and (2) the registry.
During the 6-month clinical trial period, participants will be asked to:
- Take blood pressure measurements twice daily
- Answer short weekly mobile app-based surveys
- If assigned, complete continuous heart monitoring for 2 weeks and complete 1 blood test
During the 12-month registry period, participants will be asked to:
- Take blood pressure measurements twice daily
- Answer monthly mobile app-based surveys
Researchers will compare standard blood pressure measurements and AFib screening blood pressure measurements to see if there is a difference in the time to AFib diagnosis and other cardiovascular events.
Participants will participate in two phases of the study: (1) trial and (2) the registry.
During the 6-month trial period, participants will be asked to:
- Take daily blood pressure measurements
- Answer short weekly mobile app-based surveys
- If assigned, complete continuous heart monitoring for 2 weeks and complete 1 blood test
During the 12-month registry period, participants will be asked to:
- Take daily blood pressure measurements
- Answer monthly mobile app-based surveys
Read the detailed description
This prospective, randomized controlled trial and registry aims to compare the diagnosis rate of Atrial Fibrillation (AFib) in participants with high blood pressure (BP) using either (1) a BP monitor with AFib detection technology or (2) a conventional BP monitor without AFib detection technology. Eligible participants are those who are English speaking individuals with a mailing address in the contiguous U.S., over the age of 60 with high blood pressure and meet one or more of the following:
- 70 years old or older
- BMI of 30 kg/m2 or greater -- CHA2DS2-VASc greater than or equal to 3 (excluding Female sex)
For the first 6 months, participants will be randomly assigned to use one of two blood pressure monitors, one with AFib detection (intervention group) or one without (control group). Those randomly assigned to the AFib detection BP monitor will be asked to answer short weekly mobile app-based surveys and take daily blood pressure measurements using their assigned device (4 daily measurements, 2 in the morning and 2 at night). During the first 6 months only, if an intervention group participant is notified by their device that potential AFib has been detected, they will be asked to wear a continuous ECG recording device for 2 weeks and to complete a blood test measuring NT-proBNP levels. Those randomly assigned to the BP monitor without AFib detection will be asked to answer short weekly mobile app-based surveys and take daily blood pressure measurements using their assigned device (4 daily measurements, 2 in the morning and 2 at night). During the first 6 months only, control group participants in this group may be randomly assigned to wear a continuous ECG recording device for 2 weeks and to complete a blood test measuring NT-proBNP levels. An equal number from both groups will be selected.
Following the first 6 months, participants will enter a 12-month 'Registry' phase. Participants in the control arm will receive a BP cuff with AFib detection technology. All participants will be asked to take daily measurements (4 daily, 2 in the morning and 2 at night) using the BP monitor with AFib detection and answer monthly mobile-app surveys. These surveys will be used to assess cardiovascular related events and any AFib occurrence. Some participants may be contacted for additional information. About 1,910 participants will be enrolled in this study.
- Being tested
- Blood Pressure Monitor Without AFib Detection, Blood Pressure Monitor With AFib Detection
- Keywords
- Atrial Fibrillation, Hypertension, High Blood Pressure
- Medical subject headings
- Atrial Fibrillation, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood Pressure Monitor Without AFib DetectionDevice
Also called BP5255, OMRON Silver Upper Arm Blood Pressure Monitor
Participants with this intervention will be assigned to take twice-daily blood pressure measurements using the OMRON Silver Upper Arm Blood Pressure Monitor (BP5255) with no AFib detection features for the first 6 months of study participation. During the 12-month registry, all participants will be asked to use the 7 Series Upper Arm Blood Pressure Monitor (BP7360) for their twice-daily measurements.
Blood Pressure Monitor With AFib DetectionDevice
Also called BP7360, OMRON 7 Series Upper Arm Blood Pressure Monitor
Participants with this intervention will be assigned to take twice daily blood pressure measurements using the OMRON 7 Series Upper Arm Blood Pressure Monitor (BP7360) with AFib detection features for all 18 months of study participation.
| Study group | Role | What they receive |
|---|---|---|
| Standard Blood Pressure Monitoring (No AFib Detection) | Experimental | Participants in this arm will be assigned to take twice-daily blood pressure measurements using the OMRON Silver Upper Arm Blood Pressure Monitor (BP5255) with no AFib detection features for the first 6 months of study participation. During the 12-month registry, all participants will be asked to use the OMRON 7 Series Upper Arm Blood Pressure Monitor (BP7360) for their twice-daily measurements. Receives: Device: Blood Pressure Monitor Without AFib Detection |
| Intervention Blood Pressure Monitoring (AFib Detection) | Experimental | Participants in this arm will be assigned to take twice-daily blood pressure measurements using the OMRON 7 Series Upper Arm Blood Pressure Monitor (BP7360) with AFib detection features for all 18 months of study participation. Receives: Device: Blood Pressure Monitor With AFib Detection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to first AFib diagnosis within 6 months after randomization
The primary outcome will be time to AFib diagnosis, defined as the earliest AFib confirmed on a study continuously-recording ECG patch, or AFib clinically diagnosed during usual care (recorded by a treating clinician in the medical record, independent of study ECG patch confirmation).
Measured: Throughout and up to 6-months post randomization
Secondary outcomes (3)
Diagnostic Yield of a Continuous ECG Monitor
A secondary outcome will be the diagnostic yield of high NT-proBNP detected by a blood test completed during a participant's first 6 months of participation, either for the study or during usual clinical care.
Measured: Throughout and up to 6-months post randomization
Diagnostic Yield of High NT-proBNP Cases in Blood Tests
A secondary outcome will be the diagnostic yield of high NT-proBNP detected by a blood test completed during a participant's first 6 months of participation, either for the study or during usual clinical care.
Measured: Throughout and up to 6-months post randomization
Time to First Occurrence of a 6-component Composite Event
Throughout the course of the 18-months of participation, participants will answer mobile-app based surveys regarding occurrence of cardiovascular health events including (1) ischemic stroke/TIA, (2) myocardial infarction [MI], (3) noncentral nervous system [CNS] embolism or thrombosis, (4) hospitalization or emergency department visit for HF, (5) cardiovascular hospitalization or (6) all-cause mortality. A secondary outcome will be a comparison of the time to the first occurrence of these cardiovascular health-related events between individuals who detected AFib by a continuous ECG monitor or by Pressure Pulse Wave (PPW) blood pressure monitor (with AFib detection) and those who did not.
Measured: Throughout 18-month study enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2026
- Study start1 Apr 2026
- Primary completionApr 2029 (estimated)
- Study completionApr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Atrial Fibrillation (AF)Studies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,910 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- Omron Healthcare Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- Gregory M Marcus, MD, MAS, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07582523
- Sponsor's protocol ID
- 25-45123
- Acronym
- OMRON-AF
- Status last verified
- May 2026
- First submitted
- 4 May 2026
- Last updated
- 13 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
UK National Screening Committee. https://view-health-screening-recommendations.service.gov.uk/atrial-fibrillation/. (2019).
Becher N, Metzner A, Toennis T, Kirchhof P, Schnabel RB. Atrial fibrillation burden: a new outcome predictor and therapeutic target. Eur Heart J. 2024 Aug 16;45(31):2824-2838. doi: 10.1093/eurheartj/ehae373.
PubMed 38953776Daniel E. Singer et al., J Am Coll Cardiol EP., 2025, 11(1), 110-119
US Preventive Services Task Force, JAMA, 2022, 327(4), 360-367.
Kemp Gudmundsdottir K, Svennberg E, Friberg L, Hygrell T, Frykman V, Al-Khalili F, Hijazi Z, Rosenqvist M, Engdahl J. Randomized Invitation to Systematic NT-proBNP and ECG Screening in 75-Year-Olds to Detect Atrial Fibrillation: STROKESTOP II. Circulation. 2024 Dec 3;150(23):1837-1846. doi: 10.1161/CIRCULATIONAHA.124.071176. Epub 2024 Sep 1.
PubMed 39217615Svendsen JH, Diederichsen SZ, Hojberg S, Krieger DW, Graff C, Kronborg C, Olesen MS, Nielsen JB, Holst AG, Brandes A, Haugan KJ, Kober L. Implantable loop recorder detection of atrial fibrillation to prevent stroke (The LOOP Study): a randomised controlled trial. Lancet. 2021 Oct 23;398(10310):1507-1516. doi: 10.1016/S0140-6736(21)01698-6. Epub 2021 Aug 29.
PubMed 34469766Lopes RD, Atlas SJ, Go AS, Lubitz SA, McManus DD, Dolor RJ, Chatterjee R, Rothberg MB, Rushlow DR, Crosson LA, Aronson RS, Patlakh M, Gallup D, Mills DJ, O'Brien EC, Singer DE. Effect of Screening for Undiagnosed Atrial Fibrillation on Stroke Prevention. J Am Coll Cardiol. 2024 Nov 19;84(21):2073-2084. doi: 10.1016/j.jacc.2024.08.019. Epub 2024 Sep 1.
PubMed 39230544Steinhubl SR, Waalen J, Edwards AM, Ariniello LM, Mehta RR, Ebner GS, Carter C, Baca-Motes K, Felicione E, Sarich T, Topol EJ. Effect of a Home-Based Wearable Continuous ECG Monitoring Patch on Detection of Undiagnosed Atrial Fibrillation: The mSToPS Randomized Clinical Trial. JAMA. 2018 Jul 10;320(2):146-155. doi: 10.1001/jama.2018.8102.
PubMed 29998336Gladstone DJ, Wachter R, Schmalstieg-Bahr K, Quinn FR, Hummers E, Ivers N, Marsden T, Thornton A, Djuric A, Suerbaum J, von Grunhagen D, McIntyre WF, Benz AP, Wong JA, Merali F, Henein S, Nichol C, Connolly SJ, Healey JS; SCREEN-AF Investigators and Coordinators. Screening for Atrial Fibrillation in the Older Population: A Randomized Clinical Trial. JAMA Cardiol. 2021 May 1;6(5):558-567. doi: 10.1001/jamacardio.2021.0038.
PubMed 33625468Halcox JPJ, Wareham K, Cardew A, Gilmore M, Barry JP, Phillips C, Gravenor MB. Assessment of Remote Heart Rhythm Sampling Using the AliveCor Heart Monitor to Screen for Atrial Fibrillation: The REHEARSE-AF Study. Circulation. 2017 Nov 7;136(19):1784-1794. doi: 10.1161/CIRCULATIONAHA.117.030583. Epub 2017 Aug 28.
PubMed 28851729Lubitz SA, Faranesh AZ, Atlas SJ, McManus DD, Singer DE, Pagoto S, Pantelopoulos A, Foulkes AS. Rationale and design of a large population study to validate software for the assessment of atrial fibrillation from data acquired by a consumer tracker or smartwatch: The Fitbit heart study. Am Heart J. 2021 Aug;238:16-26. doi: 10.1016/j.ahj.2021.04.003. Epub 2021 Apr 15.
PubMed 33865810Perez MV, Mahaffey KW, Hedlin H, Rumsfeld JS, Garcia A, Ferris T, Balasubramanian V, Russo AM, Rajmane A, Cheung L, Hung G, Lee J, Kowey P, Talati N, Nag D, Gummidipundi SE, Beatty A, Hills MT, Desai S, Granger CB, Desai M, Turakhia MP; Apple Heart Study Investigators. Large-Scale Assessment of a Smartwatch to Identify Atrial Fibrillation. N Engl J Med. 2019 Nov 14;381(20):1909-1917. doi: 10.1056/NEJMoa1901183.
PubMed 31722151Karakasis P, Pamporis K, Siontis KC, Theofilis P, Samaras A, Patoulias D, Stachteas P, Karagiannidis E, Stavropoulos G, Tzikas A, Kassimis G, Giannakoulas G, Karamitsos T, Katritsis DG, Fragakis N. Major clinical outcomes in symptomatic vs. asymptomatic atrial fibrillation: a meta-analysis. Eur Heart J. 2025 Apr 1;46(13):1189-1202. doi: 10.1093/eurheartj/ehae694.
PubMed 39428997Joglar JA, Chung MK, Armbruster AL, Benjamin EJ, Chyou JY, Cronin EM, Deswal A, Eckhardt LL, Goldberger ZD, Gopinathannair R, Gorenek B, Hess PL, Hlatky M, Hogan G, Ibeh C, Indik JH, Kido K, Kusumoto F, Link MS, Linta KT, Marcus GM, McCarthy PM, Patel N, Patton KK, Perez MV, Piccini JP, Russo AM, Sanders P, Streur MM, Thomas KL, Times S, Tisdale JE, Valente AM, Van Wagoner DR; Peer Review Committee Members. 2023 ACC/AHA/ACCP/HRS Guideline for the Diagnosis and Management of Atrial Fibrillation: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. Circulation. 2024 Jan 2;149(1):e1-e156. doi: 10.1161/CIR.0000000000001193. Epub 2023 Nov 30.
PubMed 38033089Noubiap JJ, Tang JJ, Teraoka JT, Dewland TA, Marcus GM. Minimum National Prevalence of Diagnosed Atrial Fibrillation Inferred From California Acute Care Facilities. J Am Coll Cardiol. 2024 Oct 15;84(16):1501-1508. doi: 10.1016/j.jacc.2024.07.014. Epub 2024 Sep 11.
PubMed 39269390
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Out-of-office Monitoring for Rhythms Of Normal Versus Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT07582523
- Acronym / sponsor ID
- OMRON-AF / 25-45123
- Keywords
- Atrial Fibrillation, Hypertension, High Blood Pressure
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 1,910 participants (estimated)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- Omron Healthcare Co., Ltd.
- Study start
- 1 Apr 2026 (actual)
- Primary completion
- Apr 2029 (estimated)
- Study completion
- Apr 2029 (estimated)
- First posted
- 13 May 2026 (actual)
- 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.
The goal of this clinical trial is to learn if screening for atrial fibrillation (AFib), a common irregular heart rhythm, through daily home blood pressure monitoring will decrease the time to atrial fibrillation diagnosis in older adults with hypertension. The main question it aims to answer is:
-- Does introducing screening for AFib using a blood pressure monitor with AFib detection technology decrease time to AFib diagnosis in patients with high blood pressure, compared to usual care using a conventional home blood pressure monitor with no AFib detection?
Participants will participate in two phases of the study: (1) clinical trial and (2) the registry.
During the 6-month clinical trial period, participants will be asked to:
- Take blood pressure measurements twice daily
- Answer short weekly mobile app-based surveys
- If assigned, complete continuous heart monitoring for 2 weeks and complete 1 blood test
During the 12-month registry period, participants will be asked to:
- Take blood pressure measurements twice daily
- Answer monthly mobile app-based surveys
Researchers will compare standard blood pressure measurements and AFib screening blood pressure measurements to see if there is a difference in the time to AFib diagnosis and other cardiovascular events.
Participants will participate in two phases of the study: (1) trial and (2) the registry.
During the 6-month trial period, participants will be asked to:
- Take daily blood pressure measurements
- Answer short weekly mobile app-based surveys
- If assigned, complete continuous heart monitoring for 2 weeks and complete 1 blood test
During the 12-month registry period, participants will be asked to:
- Take daily blood pressure measurements
- Answer monthly mobile app-based surveys
Detailed description
This prospective, randomized controlled trial and registry aims to compare the diagnosis rate of Atrial Fibrillation (AFib) in participants with high blood pressure (BP) using either (1) a BP monitor with AFib detection technology or (2) a conventional BP monitor without AFib detection technology. Eligible participants are those who are English speaking individuals with a mailing address in the contiguous U.S., over the age of 60 with high blood pressure and meet one or more of the following:
- 70 years old or older
- BMI of 30 kg/m2 or greater -- CHA2DS2-VASc greater than or equal to 3 (excluding Female sex)
For the first 6 months, participants will be randomly assigned to use one of two blood pressure monitors, one with AFib detection (intervention group) or one without (control group). Those randomly assigned to the AFib detection BP monitor will be asked to answer short weekly mobile app-based surveys and take daily blood pressure measurements using their assigned device (4 daily measurements, 2 in the morning and 2 at night). During the first 6 months only, if an intervention group participant is notified by their device that potential AFib has been detected, they will be asked to wear a continuous ECG recording device for 2 weeks and to complete a blood test measuring NT-proBNP levels. Those randomly assigned to the BP monitor without AFib detection will be asked to answer short weekly mobile app-based surveys and take daily blood pressure measurements using their assigned device (4 daily measurements, 2 in the morning and 2 at night). During the first 6 months only, control group participants in this group may be randomly assigned to wear a continuous ECG recording device for 2 weeks and to complete a blood test measuring NT-proBNP levels. An equal number from both groups will be selected.
Following the first 6 months, participants will enter a 12-month 'Registry' phase. Participants in the control arm will receive a BP cuff with AFib detection technology. All participants will be asked to take daily measurements (4 daily, 2 in the morning and 2 at night) using the BP monitor with AFib detection and answer monthly mobile-app surveys. These surveys will be used to assess cardiovascular related events and any AFib occurrence. Some participants may be contacted for additional information. About 1,910 participants will be enrolled in this study.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Blood Pressure Monitoring (No AFib Detection) | Experimental | Device: Blood Pressure Monitor Without AFib DetectionParticipants in this arm will be assigned to take twice-daily blood pressure measurements using the OMRON Silver Upper Arm Blood Pressure Monitor (BP5255) with no AFib detection features for the first 6 months of study participation. During the 12-month registry, all participants will be asked to use the OMRON 7 Series Upper Arm Blood Pressure Monitor (BP7360) for their twice-daily measurements. |
| Intervention Blood Pressure Monitoring (AFib Detection) | Experimental | Device: Blood Pressure Monitor With AFib DetectionParticipants in this arm will be assigned to take twice-daily blood pressure measurements using the OMRON 7 Series Upper Arm Blood Pressure Monitor (BP7360) with AFib detection features for all 18 months of study participation. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Hypertensive patients aged 60 years or older living in the United States who meet at least one of the following criteria:
- ≥70 years old
- BMI ≥30kg/m2
- CHA2DS2-VASc ≥3 (excluding Female sex)
Key exclusion criteria (7 listed)
- Current or prior diagnosis of atrial fibrillation (AFib), atrial flutter, or atrial tachycardia
- Receiving anticoagulation therapy
- History of skin allergies to adhesive patches
- Open wound or skin inflammation, such as eczema, in the chest region.
- Inability to wear the patch ECG monitor or apply the monitor by herself/himself or with the help of a caregiver
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 |
|---|---|---|
| Blood Pressure Monitor Without AFib DetectionAlso: BP5255, OMRON Silver Upper Arm Blood Pressure MonitorParticipants with this intervention will be assigned to take twice-daily blood pressure measurements using the OMRON Silver Upper Arm Blood Pressure Monitor (BP5255) with no AFib detection features for the first 6 months of study participation. During the 12-month registry, all participants will be asked to use the 7 Series Upper Arm Blood Pressure Monitor (BP7360) for their twice-daily measurements. | Device | Standard Blood Pressure Monitoring (No AFib Detection) |
| Blood Pressure Monitor With AFib DetectionAlso: BP7360, OMRON 7 Series Upper Arm Blood Pressure MonitorParticipants with this intervention will be assigned to take twice daily blood pressure measurements using the OMRON 7 Series Upper Arm Blood Pressure Monitor (BP7360) with AFib detection features for all 18 months of study participation. | Device | Intervention Blood Pressure Monitoring (AFib Detection) |
Primary outcome
Time to first AFib diagnosis within 6 months after randomization
Time frame: Throughout and up to 6-months post randomization
The primary outcome will be time to AFib diagnosis, defined as the earliest AFib confirmed on a study continuously-recording ECG patch, or AFib clinically diagnosed during usual care (recorded by a treating clinician in the medical record, independent of study ECG patch confirmation).
3 secondary outcomes
Diagnostic Yield of a Continuous ECG Monitor
Time frame: Throughout and up to 6-months post randomization
Diagnostic Yield of High NT-proBNP Cases in Blood Tests
Time frame: Throughout and up to 6-months post randomization
Time to First Occurrence of a 6-component Composite Event
Time frame: Throughout 18-month study enrollment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2026.
- BackgroundUK National Screening Committee. https://view-health-screening-recommendations.service.gov.uk/atrial-fibrillation/. (2019).
- Background: PubMed 38953776Becher N, Metzner A, Toennis T, Kirchhof P, Schnabel RB. Atrial fibrillation burden: a new outcome predictor and therapeutic target. Eur Heart J. 2024 Aug 16;45(31):2824-2838. doi: 10.1093/eurheartj/ehae373.
- BackgroundDaniel E. Singer et al., J Am Coll Cardiol EP., 2025, 11(1), 110-119
- BackgroundUS Preventive Services Task Force, JAMA, 2022, 327(4), 360-367.
- Background: PubMed 39217615Kemp Gudmundsdottir K, Svennberg E, Friberg L, Hygrell T, Frykman V, Al-Khalili F, Hijazi Z, Rosenqvist M, Engdahl J. Randomized Invitation to Systematic NT-proBNP and ECG Screening in 75-Year-Olds to Detect Atrial Fibrillation: STROKESTOP II. Circulation. 2024 Dec 3;150(23):1837-1846. doi: 10.1161/CIRCULATIONAHA.124.071176. Epub 2024 Sep 1.
- Background: PubMed 34469766Svendsen JH, Diederichsen SZ, Hojberg S, Krieger DW, Graff C, Kronborg C, Olesen MS, Nielsen JB, Holst AG, Brandes A, Haugan KJ, Kober L. Implantable loop recorder detection of atrial fibrillation to prevent stroke (The LOOP Study): a randomised controlled trial. Lancet. 2021 Oct 23;398(10310):1507-1516. doi: 10.1016/S0140-6736(21)01698-6. Epub 2021 Aug 29.
- Background: PubMed 39230544Lopes RD, Atlas SJ, Go AS, Lubitz SA, McManus DD, Dolor RJ, Chatterjee R, Rothberg MB, Rushlow DR, Crosson LA, Aronson RS, Patlakh M, Gallup D, Mills DJ, O'Brien EC, Singer DE. Effect of Screening for Undiagnosed Atrial Fibrillation on Stroke Prevention. J Am Coll Cardiol. 2024 Nov 19;84(21):2073-2084. doi: 10.1016/j.jacc.2024.08.019. Epub 2024 Sep 1.
- Background: PubMed 29998336Steinhubl SR, Waalen J, Edwards AM, Ariniello LM, Mehta RR, Ebner GS, Carter C, Baca-Motes K, Felicione E, Sarich T, Topol EJ. Effect of a Home-Based Wearable Continuous ECG Monitoring Patch on Detection of Undiagnosed Atrial Fibrillation: The mSToPS Randomized Clinical Trial. JAMA. 2018 Jul 10;320(2):146-155. doi: 10.1001/jama.2018.8102.
- Background: PubMed 33625468Gladstone DJ, Wachter R, Schmalstieg-Bahr K, Quinn FR, Hummers E, Ivers N, Marsden T, Thornton A, Djuric A, Suerbaum J, von Grunhagen D, McIntyre WF, Benz AP, Wong JA, Merali F, Henein S, Nichol C, Connolly SJ, Healey JS; SCREEN-AF Investigators and Coordinators. Screening for Atrial Fibrillation in the Older Population: A Randomized Clinical Trial. JAMA Cardiol. 2021 May 1;6(5):558-567. doi: 10.1001/jamacardio.2021.0038.
- Background: PubMed 28851729Halcox JPJ, Wareham K, Cardew A, Gilmore M, Barry JP, Phillips C, Gravenor MB. Assessment of Remote Heart Rhythm Sampling Using the AliveCor Heart Monitor to Screen for Atrial Fibrillation: The REHEARSE-AF Study. Circulation. 2017 Nov 7;136(19):1784-1794. doi: 10.1161/CIRCULATIONAHA.117.030583. Epub 2017 Aug 28.
- Background: PubMed 33865810Lubitz SA, Faranesh AZ, Atlas SJ, McManus DD, Singer DE, Pagoto S, Pantelopoulos A, Foulkes AS. Rationale and design of a large population study to validate software for the assessment of atrial fibrillation from data acquired by a consumer tracker or smartwatch: The Fitbit heart study. Am Heart J. 2021 Aug;238:16-26. doi: 10.1016/j.ahj.2021.04.003. Epub 2021 Apr 15.
- Background: PubMed 31722151Perez MV, Mahaffey KW, Hedlin H, Rumsfeld JS, Garcia A, Ferris T, Balasubramanian V, Russo AM, Rajmane A, Cheung L, Hung G, Lee J, Kowey P, Talati N, Nag D, Gummidipundi SE, Beatty A, Hills MT, Desai S, Granger CB, Desai M, Turakhia MP; Apple Heart Study Investigators. Large-Scale Assessment of a Smartwatch to Identify Atrial Fibrillation. N Engl J Med. 2019 Nov 14;381(20):1909-1917. doi: 10.1056/NEJMoa1901183.
- Individual participant dataSharing planned: No
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Active, not recruiting
CONVERGE Post-Approval Study (PAS)
Chronic Atrial Fibrillation
RecruitingPhase 2
Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
Atrial Fibrillation (AF)
RecruitingPhase 3
Stroke and Systemic Embolism Prevention in Adult Participants With Atrial Fibrillation
Atrial Fibrillation (AF)
Not yet recruitingObservational study
Hummingbird ICE Study
ATRIAL APPENDAGE CLOSURE for ATRIAL FIBRILLATION, 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.
Gregory M Marcus, MD, MAS principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood Pressure Monitor Without AFib Detection and Blood Pressure Monitor With AFib Detection in people with Atrial Fibrillation (AF) and Hypertension (HTN), run by University of California, San Francisco 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 4 inclusion and 7 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: enrolling by invitation, as of the sponsor's last update on 13 May 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Time to first AFib diagnosis within 6 months after randomization (time frame: Throughout and up to 6-months post randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07582523, which also lists 15 linked publications.
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 13 May 2026.