Atrial FibrillationLUX-Dx PERFORMNCT04732728
LUX-Dx Insertable Cardiac Monitor Remote Programming and Performance Study
An observational study of Atrial Fibrillation and Syncope, run by Boston Scientific Corporation at 24 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Atrial Fibrillation, Syncope, Cryptogenic Stroke
- How many people
- 727 participants
- Where
- 24 sitesUnited States
- Study dates
- 5 Mar 2021to 18 May 2023
- How long will I take part?
- 1 Year
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
24 sites in 1 country.
24 sites in 1 country
United States24 sites
Texas Cardiac Arrhythmia Research
Austin, Texas, 78705
Cardiac Arrhythmia Service
Boca Raton, Florida, 33432
St. Luke's Idaho Cardiology Associates
Boise, Idaho, 83712
Aultman Hospital
Canton, Ohio, 44710
Erlanger Medical Center
Chattanooga, Tennessee, 37403
Bethesda North Hospital
Cincinnati, Ohio, 45242
Northern Arizona Healthcare
Flagstaff, Arizona, 86001
Heart Center Research, LLC
Huntsville, Alabama, 35801
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242
University of Mississippi Medical Center
Jackson, Mississippi, 39216
Arrythmia Research Group
Jonesboro, Arkansas, 72401
Kansas City Arrhythmia Research LLC
Kansas City, Missouri, 66211
Scripps Memorial Hospital
La Jolla, California, 92037
Mount Sinai Morningside
New York, New York, 10025
Rutgers New Jersey Medical School
Newark, New Jersey, 07103
Sentara Norfolk General Hospital
Norfolk, Virginia, 23507
Presbyterian University of Pennsylvania Medical Center
Philadelphia, Pennsylvania, 19104
North Carolina Heart and Vascular Research
Raleigh, North Carolina, 27607
Monument Health Rapid City Hospital
Rapid City, South Dakota, 57701
Cox Health
Springfield, Missouri, 65807
Tallahassee Memorial Hospital
Tallahassee, Florida, 32308
The Toledo Hospital
Toledo, Ohio, 43615
PeaceHealth Southwest Medical
Vancouver, Washington, 98664
Cardiology Associates Medical Group
Ventura, California, 93003
About this study
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
- Medical subject headings
- Atrial Fibrillation, Syncope, Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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". |
What is being measured
The primary outcome is the main question the study is designed to answer.
ICM System-related Complication-free Rate at 30 Days Post-implant
Measured: 30 days
ICM System-related Complication-free Rate at 12 Months Post-implant
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2021
- Study start5 Mar 2021
- Primary completion18 May 2023
- Study completion18 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Boston Scientific CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 727 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04732728
- Sponsor's protocol ID
- 92557593
- Acronym
- LUX-Dx PERFORM
- Status last verified
- Apr 2024
- First submitted
- 27 Jan 2021
- Last updated
- 25 Nov 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Richards M, Garner JB, Rogers JD, Mahajan D, Ravikumar V, Herrmann KL, Schwartz T, Okeson B, Kupfer ME, Stolen CM, Bavikati VV, Dukes JW, Manyam H, Pokorney SD; LUX-Dx PERFORM Investigators. Safety, performance, and remote programming utilization of an insertable cardiac monitor: The LUX-Dx PERFORM study. Heart Rhythm O2. 2026 Feb 2;7(4):695-705. doi: 10.1016/j.hroo.2026.01.026. eCollection 2026 Apr.
PubMed 42038683