Trial DesignCryptogenic Stroke and underlying Atrial Fibrillation (CRYSTAL AF): Design and rationale
Section snippets
Background
Atrial fibrillation (AF) (permanent, persistent, and paroxysmal) is a potent risk factor for first and recurrent ischemic stroke. It is associated with a 5-fold increased risk for stroke and embolism and is responsible for at least one sixth of all ischemic strokes.1, 2 However, this may be an underestimate, as AF may be asymptomatic and paroxysmal and remain undetected with the short-term monitoring that most patients receive after an ischemic stroke.
In approximately 25% to 30% of cases of
Study design
The CRYSTAL AF trial (www.clinicaltrials.gov registration: NCT00924638) is a prospective, multicenter, randomized, unblinded study comparing the incidence of AF detection using REVEAL XT to routine monitoring in patients with cryptogenic stroke or TIA. The primary end point is time to AF detection in the 6 months after randomization. All end points will be adjudicated by an adjudication committee, blinded to the treatment arm, where possible. Approximately 50 centers in Europe, Canada, and the
Discussion
The CRYSTAL AF trial is a phase IV evaluation of the Reveal XT implantable cardiac monitor for the detection of AF in patients with a recent cryptogenic stroke.
The Reveal XT is currently the only implantable leadless device that has the ability to detect AF with a validated algorithm.15 A previous study has outlined the performance of the device under real-life conditions.14 Other implantable cardiac monitors might also have the capability of detecting AF; however, the safety and accuracy of
Disclosures
Authors Brachmann, Diener, Morillo, Sanna, Bernstein, Di Lazzaro, and Passman have all received grant support from the study sponsor of CRYSTAL AF, Medtronic, Inc (Minneapolis, MN). Dr Bernstein has served as a promotional speaker for Medtronic; Northwestern University receives payment for Dr Bernstein's work on the steering committee of CRYSTAL AF. Mr Beckers is an employee of Medtronic Bakken Research Center, the Netherlands. The authors are solely responsible for the design and conduct of
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Ambulatory activity in stroke survivors associated with functional outcome and quality of life: An observational cohort study
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2020, JACC: Clinical ElectrophysiologyNoninvasive detection of atrial fibrillation in cryptogenic stroke: Contribution of a new e-cardiology device
2018, HeartRhythm Case ReportsTime is brain: Balancing risk in the treatment of presumed cardioembolic stroke
2017, Journal of the Neurological SciencesLong-term detection of atrial fibrillation with insertable cardiac monitors in a real-world cryptogenic stroke population
2017, International Journal of CardiologyCitation Excerpt :The CRYSTAL-AF study was a moderately sized trial which randomized patients with a recent cryptogenic stroke to standard of care monitoring or intensive monitoring with an ICM [12]. While the trial clearly demonstrated the superiority of monitoring with an ICM compared to standard of care monitoring [13], the study reflected the specific conditions and inclusion/exclusion criteria set forth by the trial design [12]. We previously reported the short-term (6-month) incidence of AF in a large, real-world cohort of patients with an ICM placed for AF detection following cryptogenic stroke [14].
Left Atrial Dysfunction in the Pathogenesis of Cryptogenic Stroke: Novel Insights from Speckle-Tracking Echocardiography
2017, Journal of the American Society of Echocardiography
For a complete list of Steering Committee members see the online Appendix.
RCT# NCT00924638.