LUX-Dx TRENDS Evaluates Diagnostics Sensors in Heart Failure Patients Receiving Boston Scientific's Investigational ICM System.
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Heart Failure
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Masking Description: Physiologic Sensor data will be blinded to participants and care providers. LUX-Dx ICM commercial features will be Open Label.Primary Purpose: Diagnostic
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
The primary objective of this study is to collect sensor data that will be used to develop and test 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 c...
The primary objective of this study is to collect sensor data that will be used to develop and test 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.
Tracking Information
- NCT #
- NCT04790344
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Scott Solomon, MD Brigham and Women's Hospital Principal Investigator: Elaine Wan, MD Columbia University
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