Heart Failure Clinical Trial
LUX-Dx TRENDS Evaluates Diagnostics Sensors in Heart Failure Patients Receiving Boston Scientific’s Investigational ICM System.
Summary
The primary objective of this study is to collect sensor data from insertable cardiac monitor systems.
Full Description
The primary objective of this study is to collect physiological measurement data and heart failure (HF) event data that will be used to design and develop new diagnostic features for the insertable cardiac monitor (ICM) systems. This study will not have pre-defined statistical endpoints. To support the primary objective, diagnostic sensor data will be compared to reference clinical testing data and heart failure decompensation events.
Eligibility Criteria
Key Inclusion Criteria:
Patient is currently in NYHA Class II or III.
For patients with LVEF >40% measured on most recent available echocardiography within the previous 12 months:
ONE (1) of the following echocardiography findings: LA width (diameter) >3.8 cm, LA length >5.0 cm, LA area >20 cm2, LA volume >55 ml, LA volume index >29 ml/m2, LVH defined by septal thickness or posterior wall thickness of >1.1 cm AND
ONE (1) of the following: Elevated BNP/NT-proBNP as defined by: BNP >100 pg/ml or NT-proBNP >300 pg/ml within the previous 90 days for patients not in atrial fibrillation or BNP >300 pg/ml or NT-proBNP >900 pg/ml for patients in atrial fibrillation at the time of screening for eligibility OR Documented heart failure hospitalization or unscheduled heart failure IV therapy in the previous 12 months
For patients with LVEF <40% (for MI patients, measured no less than 30 days post-MI) on most recent available echocardiography within the previous 12 months:
ONE (1) of the following: Elevated BNP/NT-proBNP as defined by BNP >150 pg/ml or NT-proBNP >600 pg/ml within the previous 90 days for patients not in atrial fibrillation or BNP >450 pg/ml or NT-proBNP >1800 pg/ml for patients in atrial fibrillation at the time of screening for eligibility OR Documented heart failure hospitalization or unscheduled heart failure IV therapy in the previous 12 months
Patient is willing to be monitored in LATITUDE Clarity and use the ICM patient mobile app.
Patient is of legal age to give informed consent and is willing to participate in the trial.
Key Exclusion Criteria:
Patient is currently implanted with any other active electronic medical device.
Patient has undergone a heart transplant.
Patient is currently enrolled in another investigational study (excluding registries) without prior written approval from Boston Scientific.
Patient is known to be pregnant at the time of enrollment or plans to become pregnant during study participation.
Patient is diagnosed with amyloidosis or hypertrophic cardiomyopathy.
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There are 73 Locations for this study
Birmingham Alabama, 35243, United States More Info
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Birmingham Alabama, 35294, United States
Mesa Arizona, 85208, United States More Info
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Los Angeles California, 90027, United States More Info
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Orange California, 92868, United States More Info
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Ventura California, 55109, United States More Info
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Fort Lauderdale Florida, 33308, United States
Gainesville Florida, 32605, United States More Info
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Gainesville Florida, 32608, United States More Info
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Jacksonville Florida, 32209, United States More Info
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Jacksonville Florida, 32216, United States More Info
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Orlando Florida, 32806, United States More Info
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Port Charlotte Florida, 33952, United States
Sarasota Florida, 34239, United States More Info
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Gainesville Georgia, 30501, United States More Info
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Boise Idaho, 83712, United States More Info
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Downers Grove Illinois, 60515, United States More Info
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Indianapolis Indiana, 46237, United States More Info
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Indianapolis Indiana, 46250, United States More Info
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Iowa City Iowa, 52242, United States More Info
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Kansas City Kansas, 66160, United States More Info
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Louisville Kentucky, 40207, United States More Info
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Boston Massachusetts, 02115, United States More Info
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Maplewood Minnesota, 55109, United States More Info
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Jackson Mississippi, 39219, United States More Info
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Tupelo Mississippi, 38801, United States More Info
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Kansas City Missouri, 64111, United States More Info
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Saint Louis Missouri, 63110, United States More Info
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Lebanon New Hampshire, 03766, United States More Info
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Newark New Jersey, 07103, United States More Info
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Sewell New Jersey, 08080, United States More Info
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Albany New York, 12211, United States More Info
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New York New York, 10032, United States More Info
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New York New York, 11355, United States More Info
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Charlotte North Carolina, 28204, United States More Info
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Greensboro North Carolina, 27408, United States More Info
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Greenville North Carolina, 27834, United States More Info
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Winston-Salem North Carolina, 27157, United States More Info
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Springfield Oregon, 97477, United States More Info
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Hershey Pennsylvania, 17033, United States More Info
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Philadelphia Pennsylvania, 19107, United States More Info
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Pittsburgh Pennsylvania, 15213, United States More Info
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Charleston South Carolina, 29401, United States More Info
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Chattanooga Tennessee, 37403, United States
Nashville Tennessee, 37205, United States More Info
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Nashville Tennessee, 37232, United States More Info
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Powell Tennessee, 37849, United States More Info
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Galveston Texas, 77555, United States More Info
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Seattle Washington, 98101, United States More Info
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Seattle Washington, 98108, United States More Info
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Spokane Washington, 99204, United States More Info
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