Rationale and design of a prospective study of the clinical significance of atrial arrhythmias detected by implanted device diagnostics: The TRENDS study

• Published in: Journal of interventional cardiac electrophysiology Vol. 15; no. 1; pp. 9 - 14
• Main Authors: Glotzer, Taya V., Daoud, Emile G., Wyse, D. George, Singer, Daniel E., Holbrook, Reece, Pruett, Khadeeja, Smith, Kenneth, Hilker, Christopher E.
• Format: Journal Article
• Language: English
• Published: Netherlands Springer Nature B.V 01.01.2006
• Subjects: Anti-Arrhythmia Agents - therapeutic use; Anticoagulants; Arrhythmia; Atrial Fibrillation - complications; Atrial Fibrillation - epidemiology; Atrial Fibrillation - physiopathology; Atrial Fibrillation - therapy; Atrial Flutter - complications; Atrial Flutter - epidemiology; Atrial Flutter - physiopathology; Atrial Flutter - therapy; Cardiac arrhythmia; Cardiac Pacing, Artificial; Clinical significance; Complications; Data collection; Defibrillators, Implantable; Embolism; Fibrillation; Flutter; Follow-Up Studies; Health risks; Heart Rate; Humans; Intracranial Embolism - epidemiology; Intracranial Embolism - etiology; Ischemia; Ischemic Attack, Transient - epidemiology; Ischemic Attack, Transient - etiology; Pacemaker, Artificial; Predictive Value of Tests; Product Surveillance, Postmarketing; Prospective Studies; Quality of Life; Research Design; Risk analysis; Risk Factors; Stroke; Stroke - epidemiology; Stroke - etiology; Tachycardia; Tachycardia, Ectopic Atrial - complications; Tachycardia, Ectopic Atrial - epidemiology; Tachycardia, Ectopic Atrial - physiopathology; Tachycardia, Ectopic Atrial - therapy; Thromboembolism; Transient ischemic attack; Treatment Outcome; Trends; United States - epidemiology; United States
• ISSN: 1383-875X; 1572-8595
• DOI: 10.1007/s10840-006-7622-y

Sustained atrial fibrillation (AF) is a common risk factor for stroke. While intermittent AF also appears to pose a substantial stroke risk, the quantitative relationship between the percentage of time spent in AF and stroke risk is poorly specified and "intermittent" AF is not the same as paroxysmal AF. Improved assessment of the impact of AF burden on stroke risk will allow more targeted and safer use of antithrombotic therapy. The primary objective of this study is to determine if AT/AF (all device detected atrial tachyarrhythmias, including atrial flutter, atrial fibrillation, and atrial tachycardia) burden over a 30 day period is an independent predictor of the occurrence of ischemic stroke, transient ischemic attack (TIA) and/or systemic embolism in subjects not receiving anticoagulation therapy. TRENDS is a prospective, post-market, non-randomized, multicenter study designed to enroll 3100 subjects who have an independent Class I/II indication for cardiac rhythm device implantation and who have demographic features suggestive of an increased risk for thromboembolic complications related to AT/AF. All implanted devices will have the ability to collect long-term AT/AF burden trending data and will be equivalently programmed to ensure consistent data collection. All subjects will be followed with device interrogations every 3 months and clinic visits every 6 months for 1 year. Subjects with a documented history of AT/AF prior to enrollment and those who develop AT/AF during the 12-month follow-up will be followed until the last subject enrolled in the study has completed their 24-month follow-up. The results of the TRENDS study should help clarify the implications of data retrieved from an implantable device with regard to the risk for thromboembolic complications from atrial arrhythmias, even in the absence of symptoms.