LUX-Dx Insertable Cardiac Monitor Remote Programming and Performance Study

Atrial Fibrillation Clinical Trial

— LUX-Dx PERFORM  

Official title:

LUX-Dx Insertable Cardiac Monitor Remote Programming and Performance Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04732728
• Other study ID #: 92557593
• Status: Completed
• Start date: March 5, 2021
• Est. completion date: May 18, 2023

Study information

• Verified date: August 2023
• Source: Boston Scientific Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 727
• Est. completion date: May 18, 2023
• Est. primary completion date: May 18, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Atrial Fibrillation
• Cryptogenic Stroke
• Ischemic Stroke
• Syncope

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Boston Scientific Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Characterize the utilization of the LUX-Dx remote programming feature		12 months
Primary	Characterize the performance of the LUX-Dx arrhythmia detection algorithms		12 months
Primary	ICM System-related Complication-free Rate at 30 days post-implant		30 days
Primary	ICM System-related Complication-free Rate at 12 months post-implant		12 months