LUX-Dx TRENDS Evaluates Diagnostics Sensors in Heart Failure Patients Receiving Boston Scientific… (NCT04790344) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
LUX-Dx TRENDS Evaluates Diagnostics Sensors in Heart Failure Patients Receiving Boston Scientific's Investigational ICM System.
United States525 participantsStarted 2021-03-20
Plain-language summary
The primary objective of this study is to collect sensor data from insertable cardiac monitor systems.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 …
What they're measuring
1
Heart Failure Event Related Data will be assessed in all subjects through collection of reportable events and subsequent adjudication by the CEC.
Timeframe: Through study completion of approximately 4.5 year