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

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.

Study Overview

• Status: Completed
• Conditions: Atrial Fibrillation; Syncope; Cryptogenic Stroke

• Study Type: Observational
• Enrollment (Actual): 727

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Huntsville, Alabama, United States, 35801
      • Heart Center Research, LLC
  • Arizona
    • Flagstaff, Arizona, United States, 86001
      • Northern Arizona Healthcare
  • Arkansas
    • Jonesboro, Arkansas, United States, 72401
      • Arrythmia Research Group
  • California
    • La Jolla, California, United States, 92037
      • Scripps Memorial Hospital
    • Ventura, California, United States, 93003
      • Cardiology Associates Medical Group
  • Florida
    • Boca Raton, Florida, United States, 33432
      • Cardiac Arrhythmia Service
    • Tallahassee, Florida, United States, 32308
      • Tallahassee Memorial Hospital
  • Idaho
    • Boise, Idaho, United States, 83712
      • St. Luke's Idaho Cardiology Associates
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • University of Iowa Hospitals and Clinics
  • Mississippi
    • Jackson, Mississippi, United States, 39216
      • University of Mississippi Medical Center
  • Missouri
    • Kansas City, Missouri, United States, 66211
      • Kansas City Arrhythmia Research LLC
    • Springfield, Missouri, United States, 65807
      • Cox Health
  • New Jersey
    • Newark, New Jersey, United States, 07103
      • Rutgers New Jersey Medical School
  • New York
    • New York, New York, United States, 10025
      • Mount Sinai Morningside
  • North Carolina
    • Raleigh, North Carolina, United States, 27607
      • North Carolina Heart and Vascular Research
  • Ohio
    • Canton, Ohio, United States, 44710
      • Aultman Hospital
    • Cincinnati, Ohio, United States, 45242
      • Bethesda North Hospital
    • Toledo, Ohio, United States, 43615
      • The Toledo Hospital
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Presbyterian University of Pennsylvania Medical Center
  • South Dakota
    • Rapid City, South Dakota, United States, 57701
      • Monument Health Rapid City Hospital
  • Tennessee
    • Chattanooga, Tennessee, United States, 37403
      • Erlanger Medical Center
  • Texas
    • Austin, Texas, United States, 78705
      • Texas Cardiac Arrhythmia Research
  • Virginia
    • Norfolk, Virginia, United States, 23507
      • Sentara Norfolk General Hospital
  • Washington
    • Vancouver, Washington, United States, 98664
      • PeaceHealth Southwest Medical

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Patients that have a known heart condition and are at risk of developing an abnormal heart rhythm, or have symptoms that may suggest a cardiac arrhythmia such as dizziness, palpitations, syncope, chest pain, and/or shortness of breath.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

LUX-Dx PERFORM Study Enrollment; The first 227 subjects enrolled in the study belong to the "Safety Cohort". The number of subjects is required to fulfill the sample size requirement of the primary safety endpoint. The "Safety Cohort" subjects are not required to participate in the Holter study. Once the "Safety Cohort" enrollment is completed, all subsequent subjects are required to participate in the Holter study. All subjects who participate in the Holter study belong to the "Holter Cohort".

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
ICM System-related Complication-free Rate at 30 Days Post-implant	30 days
ICM System-related Complication-free Rate at 12 Months Post-implant	12 months

Collaborators and Investigators

• Sponsor: Boston Scientific Corporation

Study record dates

Study Major Dates

• Study Start (Actual): March 5, 2021
• Primary Completion (Actual): May 18, 2023
• Study Completion (Actual): May 18, 2023

Study Registration Dates

• First Submitted: January 27, 2021
• First Submitted That Met QC Criteria: January 27, 2021
• First Posted (Actual): February 1, 2021

Study Record Updates

• Last Update Posted (Estimated): November 25, 2024
• Last Update Submitted That Met QC Criteria: October 9, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Arrhythmias, Cardiac; Neurobehavioral Manifestations; Stroke; Consciousness Disorders; Unconsciousness; Ischemic Stroke; Atrial Fibrillation; Syncope
• Other Study ID Numbers: 92557593

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No