LUX-Dx Insertable Cardiac Monitor Remote Programming and Performance Study

Completed

Conditions studied: Atrial Fibrillation, Syncope, Cryptogenic Stroke

In brief

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.

Key facts

Study ID

NCT04732728

Run by

Boston Scientific Corporation

People needed

727

Starts

2021-03-05

Expected to finish

2023-05-18

Last updated by the study team

2024-11-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Heart Center Research, LLC — Huntsville, Alabama, United States
• Northern Arizona Healthcare — Flagstaff, Arizona, United States
• Arrythmia Research Group — Jonesboro, Arkansas, United States
• Scripps Memorial Hospital — La Jolla, California, United States
• Cardiology Associates Medical Group — Ventura, California, United States
• Cardiac Arrhythmia Service — Boca Raton, Florida, United States
• Tallahassee Memorial Hospital — Tallahassee, Florida, United States
• St. Luke's Idaho Cardiology Associates — Boise, Idaho, United States
• University of Iowa Hospitals and Clinics — Iowa City, Iowa, United States
• University of Mississippi Medical Center — Jackson, Mississippi, United States
• Kansas City Arrhythmia Research LLC — Kansas City, Missouri, United States
• Cox Health — Springfield, Missouri, United States
• Rutgers New Jersey Medical School — Newark, New Jersey, United States
• Mount Sinai Morningside — New York, New York, United States
• North Carolina Heart and Vascular Research — Raleigh, North Carolina, United States
• Aultman Hospital — Canton, Ohio, United States
• Bethesda North Hospital — Cincinnati, Ohio, United States
• The Toledo Hospital — Toledo, Ohio, United States
• Presbyterian University of Pennsylvania Medical Center — Philadelphia, Pennsylvania, United States
• Monument Health Rapid City Hospital — Rapid City, South Dakota, United States
• Erlanger Medical Center — Chattanooga, Tennessee, United States
• Texas Cardiac Arrhythmia Research — Austin, Texas, United States
• Sentara Norfolk General Hospital — Norfolk, Virginia, United States
• PeaceHealth Southwest Medical — Vancouver, Washington, United States

Full record on ClinicalTrials.gov

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