Status:
ACTIVE_NOT_RECRUITING
LUX-Dx TRENDS Evaluates Diagnostics Sensors in Heart Failure Patients Receiving Boston Scientific's Investigational ICM System.
Lead Sponsor:
Boston Scientific Corporation
Conditions:
Heart Failure
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The primary objective of this study is to collect sensor data from insertable cardiac monitor systems.
Detailed 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 ca...
Eligibility Criteria
Inclusion
- Key
- 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
- 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.
Key Trial Info
Start Date :
March 20 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2026
Estimated Enrollment :
525 Patients enrolled
Trial Details
Trial ID
NCT04790344
Start Date
March 20 2021
End Date
June 1 2026
Last Update
December 4 2025
Active Locations (56)
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1
Grandview Medical Center - Affinity Hospital, LLC
Birmingham, Alabama, United States, 35243
2
Mobile Infirmary
Mobile, Alabama, United States, 36608
3
Arrhythmia Research Group
Jonesboro, Arkansas, United States, 72401
4
John Muir Medical Center
Concord, California, United States, 94520