Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at Orange, California and other locations
Dates
study started
estimated completion

Description

Summary

The primary objective of this study is to collect sensor data from insertable cardiac monitor systems.

Official Title

LUX-Dx Heart Failure Sensors in an Insertable Cardiac Monitor System Clinical Study (LUX-Dx TRENDS)

Details

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.

Keywords

Heart Failure Investigational LUX-Dx ICM Implant

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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.

You CAN'T join if...

  • 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.

Locations

  • University of California - Irvine not yet accepting patients
    Orange California 92868 United States
  • University of Southern California Hospital not yet accepting patients
    Los Angeles California 90033 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Boston Scientific Corporation
ID
NCT04790344
Study Type
Interventional
Last Updated