Does early detection of atrial fibrillation reduce the risk of thromboembolic events? Rationale and design of the Heartline study.

BACKGROUND

The impact of using direct-to-consumer wearable devices as a means to timely detect atrial fibrillation (AF) and to improve clinical outcomes is unknown.

METHODS

Heartline is a pragmatic, randomized, and decentralized application-based trial of US participants aged ≥65 years. Two randomized cohorts include adults with possession of an iPhone and without a history of AF and those with a diagnosis of AF taking a direct oral anticoagulant (DOAC) for ≥30 days. Participants within each cohort are randomized (3:1) to either a core digital engagement program (CDEP) via iPhone application (Heartline application) and an Apple Watch (Apple Watch Group) or CDEP alone (iPhone-only Group). The Apple Watch Group has the watch irregular rhythm notification (IRN) feature enabled and access to the ECG application on the Apple Watch. If an IRN notification is issued for suspected AF then the study application instructs participants in the Apple Watch Group to seek medical care. All participants were "watch-naïve" at time of enrollment and have an option to either buy or loan an Apple Watch as part of this study. The primary end point is time from randomization to clinical diagnosis of AF, with confirmation by health care claims. Key secondary endpoint are claims-based incidence of a 6-component composite cardiovascular/systemic embolism/mortality event, DOAC medication use and adherence, costs/health resource utilization, and frequency of hospitalizations for bleeding. All study assessments, including patient-reported outcomes, are conducted through the study application. The target study enrollment is approximately 28,000 participants in total; at time of manuscript submission, a total of 26,485 participants have been enrolled into the study.

CONCLUSION

The Heartline Study will assess if an Apple Watch with the IRN and ECG application, along with application-facilitated digital health engagement modules, improves time to AF diagnosis and cardiovascular outcomes in a real-world environment.

TRIAL REGISTRATION

ClinicalTrials.gov Identifier: NCT04276441.

Informations de copyright

Copyright © 2023 The Authors. Published by Elsevier Inc. All rights reserved.

Déclaration de conflit d'intérêts

Conflict of Interest CMG: Research grant support from Johnson & Johnson and Apple. SS: Research grant from Janssen Pharmaceuticals; Employment with PhysIQ, Inc. DL: Research grant from AtriCure and Biosense Webster. Speakers engagement and advisory boards with Medtronic, Abbott, Boston Scientific, Biosense Webster. MPT: Related to the submitted work: Consulting fees from Johnson & Johnson. Outside of the submitted work: consulting fees from Medtronic Inc, Abbott, Pfizer, Sanofi, InCarda, 100Plus, AliveCor, Acutus, Sanofi, Bristol Myers Squibb, Medtronic; grants from Bristol Myers Squibb, American Heart Association, Sanofi, Apple, Bayer, Gilead, US Food and Drug Administration, employment from iRhythm Technologies. RP: Advisory boards for Johnson & Johnson, Abbott, Medtronic; research support Abbott and American Heart Association. WSJ: Research grants from Bayer, Boehringer Ingelheim, Janssen, Merck, Novartis, National Institute on Aging, Patient-Centered Outcomes Research Institute. TJB: Research grant support from Boehringer Ingelheim, Altathera, Boston Scientific. ABC: Advisory board for Janssen Pharmaceuticals, Medtronic Inc., Abbott, Sanofi Aventis, Milestone Pharmaceuticals, Eagle Pharmaceuticals; honoraria for speaking from Medtronic Inc., Abbott, Sanofi Aventis, Milestone Pharmaceuticals. EP: Research support from Janssen, Bristol-Myers Squibb, Amgen, Esperion; Advisory boards for Novartis, Novo Nordisk, Cerner. JR: Advisory boards for Acesion Pharma and InCarda; consultant for Advanced Medical Education, Element Science, GV, Inc.; steering committee for Janssen; stock options for AblaCor, Element Science, InfoBionic, LuxCath, NewPace, Celero Systems. LS: consultant for Abbott and executive committee member for Johnson & Johnson Heartline trial. MT: Employee of Tiltas Solutions; no other competing interests to disclose. KGT: Full-time employee of Medtronic. NM: Consultant for AtriCure Biosense Webster, Sanofi, Pfizer; honoraria for speaking: Biotronik, Bristol Myers Squibb, Sanofi; research grants from Biosense Webster, St. Jude Medical, Johnson & Johnson, Medtronic, Boston Scientific. MP: Employee of and may hold stock in Apple. AH, SK, JN, SJ, KW, and CVD: employees of Janssen and may hold stock in Johnson & Johnson. JAS: Principal investigator of grants from NIH, Abbott Vascular, and the American College of Cardiology Foundation; consultant to Janssen, Novartis, Amgen, Bristol Myers Squibb, AstraZeneca, Bayer, Terumo, Merck; Scientific Advisory Board of UnitedHealthcare and Board of Directors for Blue Cross and Blue Shield of Kansas City; Copyright owner of the KCCQ, SAQ, and PAQ.