LUX-Dx Insertable Cardiac Monitor Remote Programming and Performance Study

NCT ID: NCT04732728

Last Updated: 2024-11-25

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 727 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-03-05
• Study Completion Date: 2023-05-18

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.

Conditions

Atrial Fibrillation; Syncope; Cryptogenic Stroke

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

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".

No interventions assigned to this group

Eligibility Criteria

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.

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Boston Scientific Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Heart Center Research, LLC

Huntsville, Alabama, United States

Northern Arizona Healthcare

Flagstaff, Arizona, United States

Arrythmia Research Group

Jonesboro, Arkansas, United States

Scripps Memorial Hospital

La Jolla, California, United States

Cardiology Associates Medical Group

Ventura, California, United States

Cardiac Arrhythmia Service

Boca Raton, Florida, 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

Kansas City Arrhythmia Research LLC

Kansas City, Missouri, United States

Cox Health

Springfield, Missouri, United States

Rutgers New Jersey Medical School

Newark, New Jersey, United States

Mount Sinai Morningside

New York, New York, United States

North Carolina Heart and Vascular Research

Raleigh, North Carolina, United States

Aultman Hospital

Canton, Ohio, United States

Bethesda North Hospital

Cincinnati, Ohio, United States

The Toledo Hospital

Toledo, Ohio, United States

Presbyterian University of Pennsylvania Medical Center

Philadelphia, Pennsylvania, United States

Monument Health Rapid City Hospital

Rapid City, South Dakota, United States

Erlanger Medical Center

Chattanooga, Tennessee, United States

Texas Cardiac Arrhythmia Research

Austin, Texas, United States

Sentara Norfolk General Hospital

Norfolk, Virginia, United States

PeaceHealth Southwest Medical

Vancouver, Washington, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

92557593

Identifier Type: -

Identifier Source: org_study_id