Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| NOPRODAFL0002 | Other Identifier | Janssen Research & Development, LLC |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Apple Inc. | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
The primary objectives of this study are to identify and diagnose Atrial Fibrillation (AF), evaluate improvement in cardiovascular (CV) outcomes, improve direct oral anti-coagulant (DOAC) adherence and persistence, and better characterize participants and identify predictors of disease.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Non- Atrial Fibrillation (AF) Cohort | Participants without a history of AF will be randomly assigned into the study to either an Apple Watch/iPhone group or an iPhone group only. |
| |
| Atrial Fibrillation (AF) Cohort | Participants with a diagnosis of AF taking a direct oral anti-coagulant (DOAC) for at least 30 days will be randomly assigned to Apple Watch/iPhone group or iPhone group only. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Heart healthy Engagement Program with the Apple Watch Series 5 or later | Device | No drug will be given as part of this study. Participants without a diagnosis of AF will be enrolled and a heart healthy Engagement Program delivered via the Heartline app on the iPhone with the Apple Watch Series 5 or later. |
| Measure | Description | Time Frame |
|---|---|---|
| Time from Randomization to Clinical Diagnosis of Atrial Fibrillation (AF) | Time to a clinical diagnosis of AF obtained from healthcare claims database. | Up to 3 years |
| Percent Days Covered (PDC) by Direct Oral Anti-Coagulant (DOAC) Prescription Fills | Percent days of covered prescription DOAC use minus any evidence of no prescription use/refills over the time interval chosen. | Up to 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Composite of 6-component Events (Ischemic Stroke/TIA, MI, Non-CNS Embolism or Thrombosis, Hospitalization or ED Visit for HF, CV Hospitalization and ACM) | Time to composite of 6-component events (ischemic stroke/transient ischemic attack [TIA], myocardial infarction [MI], non-central nervous system [CNS] embolism or thrombosis, hospitalization or emergency department [ED] visit due to heart failure [HF], cardiovascular [CV] hospitalization, and all-cause mortality [ACM]), obtained from randomization in the healthcare claims database, will be reported. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
The study population includes an older age group in whom the risk of developing Atrial Fibrillation (AF) is increased and who may benefit from a broad, health-focused Engagement Program paired with the irregular rhythm notification (IRN) alert (photoplethysmogram [PPG] sensor based) and electrocardiogram (ECG) sensor of the Apple Watch Series 5 or later.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Janssen Scientific Affairs, LLC Clinical Trial | Janssen Scientific Affairs, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Evidation Health | San Mateo | California | 94401 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41875816 | Derived | Hills MT, Korjian S, Chi G, Natale A, Saxon L, Ferdinand KC, Kwaku KF, Brancato S, Hughes A, Baca-Motes K, Steinhubl SR, Wessler J, Goldberg N, Asthana A, Shute K, Applebaum J, Doran K, Nikolovski J, Kaul S, Wentworth D, Damaraju CV, Tavakoli C, Patel M, Curtis AB, Spertus JA, Gibson CM; Heartline Executive Committee and Steering Committee. Direct-to-Participant Enrollment in a Virtual Trial: Lessons Learned From the Heartline Study. JACC Adv. 2026 Apr;5(4):102662. doi: 10.1016/j.jacadv.2026.102662. Epub 2026 Mar 23. | |
| 40839901 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Anti-Coagulation Adherence Module with the Apple Watch Series 5 or later | Device | No drug will be given as part of this study. Participants with a diagnosis of AF (taking a DOAC for at least 30 days) will be enrolled and an Anti-Coagulation Adherence Module delivered via the Heartline app on the iPhone with an Apple Watch Series 5 or later. |
|
| Up to 3 years |
| Summary of Total Cost of Care Delivery, Total Health Resource Utilization (HRU), and Cost Effectiveness | Summary of total cost of care delivery, total HRU, and cost effectiveness will be reported. Total costs of care reported as number of HRU events times the unit cost for each event. HRU reported as counts of HRU events. Cost effectiveness to be assessed by including the cost to diagnosis, treatment and reported clinical outcome. | Up to 3 years |
| Time to Ischemic stroke/TIA | Ischemic stroke/TIA is defined as a hospitalization/diagnosis for Ischemic stroke/TIA. | Up to 3 years |
| Time to MI | MI is defined as a hospitalization/diagnosis for MI. | Up to 3 years |
| Time to non-CNS Embolism or Thrombosis | Non-CNS embolism or thrombosis is defined as hospitalization for non-CNS thromboembolic events. | Up to 3 years |
| Time to Hospitalization or ED for HF | Hospitalization or ED visit for HF is defined as an in-patient stay or an outpatient ED visit for HF. | Up to 3 years |
| Time to CV Hospitalization | Hospitalization for CV is defined as an in-patient stay for CV disease. | Up to 3 years |
| Time to all-Cause Mortality | All-cause mortality (ACM) is defined as deaths from all (reported) causes. | Up to 3 years |
| Time to Composite Bleeding Events Resulting in Hospitalization | Hospitalization for composite bleeding events (such as intracranial hemorrhage, gastrointestinal [GI], respiratory, intraocular) is defined as in-patient stay for bleeding events, as reported in the healthcare claims database. | Up to 3 years |
| Time to Hospitalization for Hemorrhagic Stroke | Hospitalization for hemorrhagic stroke is defined as an in-patient stay for a hemorrhagic stroke. | Up to 3 years |
| Derived |
| Nikolovski J, Navar AM, Steinhubl S, Baca-Motes K, Curtis AB, Peterson ED, Lakkireddy D, Tarino M, Juan S, Damaraju CRV, Wentworth D, Wildenhaus K, Patel M, Tavakoli C, Gibson CM, Spertus JA; Heartline Steering Committee. The Heartline Experience: Achieving Long-Term Participant Engagement in Digital Health Technology Trials. JACC Adv. 2025 Sep;4(9):102072. doi: 10.1016/j.jacadv.2025.102072. Epub 2025 Aug 20. |
| 39393635 | Derived | Grine M, Guerreiro C, Moscoso Costa F, Nobre Menezes M, Ladeiras-Lopes R, Ferreira D, Oliveira-Santos M. Digital health in cardiovascular medicine: An overview of key applications and clinical impact by the Portuguese Society of Cardiology Study Group on Digital Health. Rev Port Cardiol. 2025 Feb;44(2):107-119. doi: 10.1016/j.repc.2024.08.009. Epub 2024 Oct 10. English, Portuguese. |
| 36642226 | Derived | Gibson CM, Steinhubl S, Lakkireddy D, Turakhia MP, Passman R, Jones WS, Bunch TJ, Curtis AB, Peterson ED, Ruskin J, Saxon L, Tarino M, Tarakji KG, Marrouche N, Patel M, Harxhi A, Kaul S, Nikolovski J, Juan S, Wildenhaus K, Damaraju CV, Spertus JA; Heartline Steering Committee. Does early detection of atrial fibrillation reduce the risk of thromboembolic events? Rationale and design of the Heartline study. Am Heart J. 2023 May;259:30-41. doi: 10.1016/j.ahj.2023.01.004. Epub 2023 Jan 12. |
| 34029345 | Derived | Nikolovski J, Koldijk M, Weverling GJ, Spertus J, Turakhia M, Saxon L, Gibson M, Whang J, Sarich T, Zambon R, Ezeanochie N, Turgiss J, Jones R, Stoddard J, Burton P, Navar AM. Factors indicating intention to vaccinate with a COVID-19 vaccine among older U.S. adults. PLoS One. 2021 May 24;16(5):e0251963. doi: 10.1371/journal.pone.0251963. eCollection 2021. |
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided