LUX-Dx Insertable Cardiac Monitor Remote Programming and Performance Study

Completed

Conditions: Atrial Fibrillation
Cryptogenic Stroke
Syncope

Registration Number: NCT04732728

Lead Sponsor: Boston Scientific Corporation

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) 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 727

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 & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
ICM System-related Complication-free Rate at 12 Months Post-implant	12 months
ICM System-related Complication-free Rate at 30 Days Post-implant	30 days

Secondary Outcome Measures

Name	Time	Method

Trial Locations

Locations (24): Cardiac Arrhythmia Service
🇺🇸
Boca Raton, Florida, United States
North Carolina Heart and Vascular Research
🇺🇸
Raleigh, North Carolina, United States
Presbyterian University of Pennsylvania Medical Center
🇺🇸
Philadelphia, Pennsylvania, United States
Bethesda North Hospital
🇺🇸
Cincinnati, Ohio, United States
Heart Center Research, LLC
🇺🇸
Huntsville, Alabama, United States
Scripps Memorial Hospital
🇺🇸
La Jolla, California, United States
Arrythmia Research Group
🇺🇸
Jonesboro, Arkansas, United States
Cardiology Associates Medical Group
🇺🇸
Ventura, California, United States
Northern Arizona Healthcare
🇺🇸
Flagstaff, Arizona, 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
The Toledo Hospital
🇺🇸
Toledo, Ohio, United States
Rutgers New Jersey Medical School
🇺🇸
Newark, New Jersey, United States
Cox Health
🇺🇸
Springfield, Missouri, United States
Mount Sinai Morningside
🇺🇸
New York, New York, United States
Aultman Hospital
🇺🇸
Canton, Ohio, United States
Monument Health Rapid City Hospital
🇺🇸
Rapid City, South Dakota, United States
Erlanger Medical Center
🇺🇸
Chattanooga, Tennessee, United States
Sentara Norfolk General Hospital
🇺🇸
Norfolk, Virginia, United States
PeaceHealth Southwest Medical
🇺🇸
Vancouver, Washington, United States
Kansas City Arrhythmia Research LLC
🇺🇸
Kansas City, Missouri, United States
Texas Cardiac Arrhythmia Research
🇺🇸
Austin, Texas, United States