LUX-Dx Insertable Cardiac Monitor Remote Programming and Performance Study
LUX-Dx Insertable Cardiac Monitor Remote Programming and Performance Study
The LUX-Dx PERFORM Study will characterize, in a general patient population, the utilization
 of the remote programming feature of the Boston Scientific (BSC) Insertable Cardiac Monitor
 (ICM) device. The study will also collect data to characterize the performance of arrhythmia
 detection algorithms. Finally, data collected will be used to analyze and characterize the
 ICM system-related safety events.
Inclusion Criteria:

 -  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.

 Exclusion Criteria:

 -  Patient is indicated for implantation of, or is currently implanted with an active
 implantable cardiac device (e.g., LVAD, ICD, CRT D, PPM*).

 -  Patient cannot tolerate a subcutaneous, chronically-inserted device due to medical
 condition.

 -  Patient has a documented life expectancy of less than 12 months (per investigator's
 discretion).

 -  Patient is known to be pregnant at the time of study enrollment (method of assessment
 upon investigator's discretion).

 -  Patient is currently enrolled in another clinical study including observational
 studies/registries, unless prior written approval from BSC is obtained. Mandatory
 governmental registries are accepted for co-enrollment without approval by BSC.

 The following exclusion criteria are applicable for patients participating in the Holter
 study:

 -  Patient has known allergies to the adhesive materials or hydrogel used in the extended
 Holter monitoring.

 -  Patient has broken, damaged, or irritated skin over the chest area where the extended
 Holter monitor will be attached.