LUX-Dx Insertable Cardiac Monitor Remote Programming and Performance Study
LUX-Dx PERFORM
1 other identifier
observational
727
1 country
24
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2021
Typical duration for all trials
24 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 27, 2021
CompletedFirst Posted
Study publicly available on registry
February 1, 2021
CompletedStudy Start
First participant enrolled
March 5, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 18, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
May 18, 2023
CompletedResults Posted
Study results publicly available
November 25, 2024
CompletedNovember 25, 2024
April 1, 2024
2.2 years
January 27, 2021
April 2, 2024
October 9, 2024
Conditions
Outcome Measures
Primary Outcomes (2)
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
Study Arms (1)
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".
Eligibility Criteria
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.
You may qualify if:
- 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.
- Patient can tolerate the adhesive used in the Holter monitoring for an extended period of time.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (24)
Heart Center Research, LLC
Huntsville, Alabama, 35801, United States
Northern Arizona Healthcare
Flagstaff, Arizona, 86001, United States
Arrythmia Research Group
Jonesboro, Arkansas, 72401, United States
Scripps Memorial Hospital
La Jolla, California, 92037, United States
Cardiology Associates Medical Group
Ventura, California, 93003, United States
Cardiac Arrhythmia Service
Boca Raton, Florida, 33432, United States
Tallahassee Memorial Hospital
Tallahassee, Florida, 32308, United States
St. Luke's Idaho Cardiology Associates
Boise, Idaho, 83712, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242, United States
University of Mississippi Medical Center
Jackson, Mississippi, 39216, United States
Kansas City Arrhythmia Research LLC
Kansas City, Missouri, 66211, United States
Cox Health
Springfield, Missouri, 65807, United States
Rutgers New Jersey Medical School
Newark, New Jersey, 07103, United States
Mount Sinai Morningside
New York, New York, 10025, United States
North Carolina Heart and Vascular Research
Raleigh, North Carolina, 27607, United States
Aultman Hospital
Canton, Ohio, 44710, United States
Bethesda North Hospital
Cincinnati, Ohio, 45242, United States
The Toledo Hospital
Toledo, Ohio, 43615, United States
Presbyterian University of Pennsylvania Medical Center
Philadelphia, Pennsylvania, 19104, United States
Monument Health Rapid City Hospital
Rapid City, South Dakota, 57701, United States
Erlanger Medical Center
Chattanooga, Tennessee, 37403, United States
Texas Cardiac Arrhythmia Research
Austin, Texas, 78705, United States
Sentara Norfolk General Hospital
Norfolk, Virginia, 23507, United States
PeaceHealth Southwest Medical
Vancouver, Washington, 98664, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Thomas Stoltz, Clinical Trial Manager
- Organization
- Boston Scientific
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Target Duration
- 1 Year
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 27, 2021
First Posted
February 1, 2021
Study Start
March 5, 2021
Primary Completion
May 18, 2023
Study Completion
May 18, 2023
Last Updated
November 25, 2024
Results First Posted
November 25, 2024
Record last verified: 2024-04
Data Sharing
- IPD Sharing
- Will not share