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LUX-Dx PERFORM: LUX-Dx Insertable Cardiac Monitor Remote Programming and Performance Study

Sponsor
Boston Scientific Corporation (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT04732728
Collaborator
(none)
727
Enrollment
24
Locations
25.9
Anticipated Duration (Months)
30.3
Patients Per Site
1.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational [Patient Registry]
    Actual Enrollment :
    727 participants
    Observational Model:
    Other
    Time Perspective:
    Prospective
    Official Title:
    LUX-Dx Insertable Cardiac Monitor Remote Programming and Performance Study
    Actual Study Start Date :
    Mar 5, 2021
    Anticipated Primary Completion Date :
    May 1, 2023
    Anticipated Study Completion Date :
    May 1, 2023

    Arms and Interventions

    Arm Intervention/Treatment
    Safety Cohort

    No intervention will be administered to subjects that comprise the safety cohort.
    Holter Cohort

    No intervention will be administered to subjects that comprise the safety cohort.

    Outcome Measures

    Primary Outcome Measures

    1. Characterize the utilization of the LUX-Dx remote programming feature [12 months]

    2. Characterize the performance of the LUX-Dx arrhythmia detection algorithms [12 months]

    3. ICM System-related Complication-free Rate at 30 days post-implant [30 days]

    4. ICM System-related Complication-free Rate at 12 months post-implant [12 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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,
    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 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    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
    5 Cardiology Associates Medical Group Ventura California United States 93003
    6 Cardiac Arrhythmia Service Boca Raton Florida United States 33432
    7 Tallahassee Memorial Hospital Tallahassee Florida United States 32308
    8 St. Luke's Idaho Cardiology Associates Boise Idaho United States 83712
    9 University of Iowa Hospitals and Clinics Iowa City Iowa United States 52242
    10 University of Mississippi Medical Center Jackson Mississippi United States 39216
    11 Kansas City Arrhythmia Research LLC Kansas City Missouri United States 66211
    12 Cox Health Springfield Missouri United States 65807
    13 Rutgers New Jersey Medical School Newark New Jersey United States 07103
    14 Mount Sinai Morningside New York New York United States 10025
    15 North Carolina Heart and Vascular Research Raleigh North Carolina United States 27607
    16 Aultman Hospital Canton Ohio United States 44710
    17 Bethesda North Hospital Cincinnati Ohio United States 45242
    18 The Toledo Hospital Toledo Ohio United States 43615
    19 Presbyterian University of Pennsylvania Medical Center Philadelphia Pennsylvania United States 19104
    20 Monument Health Rapid City Hospital Rapid City South Dakota United States 57701
    21 Erlanger Medical Center Chattanooga Tennessee United States 37403
    22 Texas Cardiac Arrhythmia Research Austin Texas United States 78705
    23 Sentara Norfolk General Hospital Norfolk Virginia United States 23507
    24 PeaceHealth Southwest Medical Vancouver Washington United States 98664

    Sponsors and Collaborators

    • Boston Scientific Corporation

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Boston Scientific Corporation
    ClinicalTrials.gov Identifier:
    NCT04732728
    Other Study ID Numbers:
    • 92557593
    First Posted:
    Feb 1, 2021
    Last Update Posted:
    Aug 8, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Syncope
    Ischemic Stroke
    Atrial Fibrillation

    Study Results

    No Results Posted as of Aug 8, 2022