Status:
COMPLETED
LUX-Dx Insertable Cardiac Monitor Remote Programming and Performance Study
Lead Sponsor:
Boston Scientific Corporation
Conditions:
Atrial Fibrillation
Syncope
Eligibility:
All Genders
18+ years
Brief Summary
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) Inser...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 5 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 18 2023
Estimated Enrollment :
727 Patients enrolled
Trial Details
Trial ID
NCT04732728
Start Date
March 5 2021
End Date
May 18 2023
Last Update
November 25 2024
Active Locations (24)
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1
Heart Center Research, LLC
Huntsville, Alabama, United States, 35801
2
Northern Arizona Healthcare
Flagstaff, Arizona, United States, 86001
3
Arrythmia Research Group
Jonesboro, Arkansas, United States, 72401
4
Scripps Memorial Hospital
La Jolla, California, United States, 92037