Phase
Condition
Arrhythmia
Blood Clots
Chest Pain
Treatment
N/AClinical Study ID
Ages > 18 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Patient is indicated to be implanted with the LUX-Dx ICM for one of the followingreasons (grouped in three "Reason for Monitoring" subgroups): 1) Cryptogenic stroke,
- 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 toinclude the use of a legally authorized representative (LAR) for documentation ofinformed 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 specificto 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
Exclusion Criteria:
Patient is indicated for implantation of, or is currently implanted with an activeimplantable cardiac device (e.g., LVAD, ICD, CRT D, PPM*).
Patient cannot tolerate a subcutaneous, chronically-inserted device due to medicalcondition.
Patient has a documented life expectancy of less than 12 months (per investigator'sdiscretion).
Patient is known to be pregnant at the time of study enrollment (method ofassessment upon investigator's discretion).
Patient is currently enrolled in another clinical study including observationalstudies/registries, unless prior written approval from BSC is obtained. Mandatorygovernmental 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 theextended Holter monitoring.
Patient has broken, damaged, or irritated skin over the chest area where theextended Holter monitor will be attached.
Study Design
Connect with a study center
Heart Center Research, LLC
Huntsville, Alabama 35801
United StatesSite Not Available
Northern Arizona Healthcare
Flagstaff, Arizona 86001
United StatesSite Not Available
Arrythmia Research Group
Jonesboro, Arkansas 72401
United StatesSite Not Available
Scripps Memorial Hospital
La Jolla, California 92037
United StatesSite Not Available
Cardiology Associates Medical Group
Ventura, California 93003
United StatesSite Not Available
Cardiac Arrhythmia Service
Boca Raton, Florida 33432
United StatesSite Not Available
Tallahassee Memorial Hospital
Tallahassee, Florida 32308
United StatesSite Not Available
St. Luke's Idaho Cardiology Associates
Boise, Idaho 83712
United StatesSite Not Available
University of Iowa Hospitals and Clinics
Iowa City, Iowa 52242
United StatesSite Not Available
University of Mississippi Medical Center
Jackson, Mississippi 39216
United StatesSite Not Available
Kansas City Arrhythmia Research LLC
Kansas City, Missouri 66211
United StatesSite Not Available
Cox Health
Springfield, Missouri 65807
United StatesSite Not Available
Rutgers New Jersey Medical School
Newark, New Jersey 07103
United StatesSite Not Available
Mount Sinai Morningside
New York, New York 10025
United StatesSite Not Available
North Carolina Heart and Vascular Research
Raleigh, North Carolina 27607
United StatesSite Not Available
Aultman Hospital
Canton, Ohio 44710
United StatesSite Not Available
Bethesda North Hospital
Cincinnati, Ohio 45242
United StatesSite Not Available
The Toledo Hospital
Toledo, Ohio 43615
United StatesSite Not Available
Presbyterian University of Pennsylvania Medical Center
Philadelphia, Pennsylvania 19104
United StatesSite Not Available
Monument Health Rapid City Hospital
Rapid City, South Dakota 57701
United StatesSite Not Available
Erlanger Medical Center
Chattanooga, Tennessee 37403
United StatesSite Not Available
Texas Cardiac Arrhythmia Research
Austin, Texas 78705
United StatesSite Not Available
Sentara Norfolk General Hospital
Norfolk, Virginia 23507
United StatesSite Not Available
PeaceHealth Southwest Medical
Vancouver, Washington 98664
United StatesSite Not Available

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