LUX-Dx Insertable Cardiac Monitor Remote Programming and Performance Study

Last updated: October 9, 2024
Sponsor: Boston Scientific Corporation
Overall Status: Completed

Phase

N/A

Condition

Arrhythmia

Blood Clots

Chest Pain

Treatment

N/A

Clinical Study ID

NCT04732728
92557593
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study 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) 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patient is indicated to be implanted with the LUX-Dx ICM for one of the followingreasons (grouped in three "Reason for Monitoring" subgroups): 1) Cryptogenic stroke,
  1. 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 toinclude the use of a legally authorized representative (LAR) for documentation ofinformed 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 specificto 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

Exclusion Criteria:

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

  • Patient cannot tolerate a subcutaneous, chronically-inserted device due to medicalcondition.

  • Patient has a documented life expectancy of less than 12 months (per investigator'sdiscretion).

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

  • Patient is currently enrolled in another clinical study including observationalstudies/registries, unless prior written approval from BSC is obtained. Mandatorygovernmental 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 theextended Holter monitoring.

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

Study Design

Total Participants: 727
Study Start date:
March 05, 2021
Estimated Completion Date:
May 18, 2023

Connect with a study center

  • Heart Center Research, LLC

    Huntsville, Alabama 35801
    United States

    Site Not Available

  • Northern Arizona Healthcare

    Flagstaff, Arizona 86001
    United States

    Site Not Available

  • Arrythmia Research Group

    Jonesboro, Arkansas 72401
    United States

    Site Not Available

  • Scripps Memorial Hospital

    La Jolla, California 92037
    United States

    Site Not Available

  • Cardiology Associates Medical Group

    Ventura, California 93003
    United States

    Site Not Available

  • Cardiac Arrhythmia Service

    Boca Raton, Florida 33432
    United States

    Site Not Available

  • Tallahassee Memorial Hospital

    Tallahassee, Florida 32308
    United States

    Site Not Available

  • St. Luke's Idaho Cardiology Associates

    Boise, Idaho 83712
    United States

    Site Not Available

  • University of Iowa Hospitals and Clinics

    Iowa City, Iowa 52242
    United States

    Site Not Available

  • University of Mississippi Medical Center

    Jackson, Mississippi 39216
    United States

    Site Not Available

  • Kansas City Arrhythmia Research LLC

    Kansas City, Missouri 66211
    United States

    Site Not Available

  • Cox Health

    Springfield, Missouri 65807
    United States

    Site Not Available

  • Rutgers New Jersey Medical School

    Newark, New Jersey 07103
    United States

    Site Not Available

  • Mount Sinai Morningside

    New York, New York 10025
    United States

    Site Not Available

  • North Carolina Heart and Vascular Research

    Raleigh, North Carolina 27607
    United States

    Site Not Available

  • Aultman Hospital

    Canton, Ohio 44710
    United States

    Site Not Available

  • Bethesda North Hospital

    Cincinnati, Ohio 45242
    United States

    Site Not Available

  • The Toledo Hospital

    Toledo, Ohio 43615
    United States

    Site Not Available

  • Presbyterian University of Pennsylvania Medical Center

    Philadelphia, Pennsylvania 19104
    United States

    Site Not Available

  • Monument Health Rapid City Hospital

    Rapid City, South Dakota 57701
    United States

    Site Not Available

  • Erlanger Medical Center

    Chattanooga, Tennessee 37403
    United States

    Site Not Available

  • Texas Cardiac Arrhythmia Research

    Austin, Texas 78705
    United States

    Site Not Available

  • Sentara Norfolk General Hospital

    Norfolk, Virginia 23507
    United States

    Site Not Available

  • PeaceHealth Southwest Medical

    Vancouver, Washington 98664
    United States

    Site Not Available

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