Clinical trial NCT04732728: LUX-Dx Insertable Cardiac Monitor Remote Programming and Performance Study
Official title: LUX-Dx Insertable Cardiac Monitor Remote Programming and Performance Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Syncope
Cryptogenic Stroke
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2021-02-01
Enrollment: 727
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
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.

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.


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.

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.

Primary outcomes:
measure: ICM System-related Complication-free Rate at 30 Days Post-implant
timeFrame: 30 days
measure: ICM System-related Complication-free Rate at 12 Months Post-implant
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: Heart Center Research, LLC
state: Alabama
city: Flagstaff
country: United States
facility: Northern Arizona Healthcare
state: Arizona
city: Jonesboro
country: United States
facility: Arrythmia Research Group
state: Arkansas
city: La Jolla
country: United States
facility: Scripps Memorial Hospital
state: California
city: Ventura
country: United States
facility: Cardiology Associates Medical Group
state: California
city: Boca Raton
country: United States
facility: Cardiac Arrhythmia Service
state: Florida
city: Tallahassee
country: United States
facility: Tallahassee Memorial Hospital
state: Florida
city: Boise
country: United States
facility: St. Luke's Idaho Cardiology Associates
state: Idaho
city: Iowa City
country: United States
facility: University of Iowa Hospitals and Clinics
state: Iowa
city: Jackson
country: United States
facility: University of Mississippi Medical Center
state: Mississippi
city: Kansas City
country: United States
facility: Kansas City Arrhythmia Research LLC
state: Missouri
city: Springfield
country: United States
facility: Cox Health
state: Missouri
city: Newark
country: United States
facility: Rutgers New Jersey Medical School
state: New Jersey
city: New York
country: United States
facility: Mount Sinai Morningside
state: New York
city: Raleigh
country: United States
facility: North Carolina Heart and Vascular Research
state: North Carolina
city: Canton
country: United States
facility: Aultman Hospital
state: Ohio
city: Cincinnati
country: United States
facility: Bethesda North Hospital
state: Ohio
city: Toledo
country: United States
facility: The Toledo Hospital
state: Ohio
city: Philadelphia
country: United States
facility: Presbyterian University of Pennsylvania Medical Center
state: Pennsylvania
city: Rapid City
country: United States
facility: Monument Health Rapid City Hospital
state: South Dakota
city: Chattanooga
country: United States
facility: Erlanger Medical Center
state: Tennessee
city: Austin
country: United States
facility: Texas Cardiac Arrhythmia Research
state: Texas
city: Norfolk
country: United States
facility: Sentara Norfolk General Hospital
state: Virginia
city: Vancouver
country: United States
facility: PeaceHealth Southwest Medical
state: Washington
Study officials:
References: