LUX-Dx Insertable Cardiac Monitor Remote Programming and Performance Study
The LUX-Dx PERFORM Study had two primary objects which were (1) to characterize, in a general patient population, the utilization of the remote programming feature of the Boston Scientific (BSC) Insertable Cardiac Monitor (ICM) device and (2) to collect data to characterize the performance of arrhythmia detection algorithms. Data was also collected to characterize the ICM system related safety events.
• Patient is indicated to be implanted with the LUX-Dx ICM for one of the following reasons (grouped in three Reason for Monitoring subgroups): 1) Cryptogenic stroke, 2) Syncope, 3) AF management, Post-AF ablation, or Suspected AF
• Patient is willing to enroll and be monitored in LATITUDE Clarity.
• Patient is willing and able to be followed remotely via the ICM patient mobile app.
• Patient is willing and capable of providing informed consent (which is not to include the use of a legally authorized representative (LAR) for documentation of informed consent) and agrees to participate in all protocol required activities.
• Patient is age 18 years or above, or of legal age to give informed consent specific to state and national law.
⁃ The following inclusion criterion is applicable for patients participating in the Holter study:
⁃ • Patient can tolerate the adhesive used in the Holter monitoring for an extended period of time.