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LUX-Dx TRENDS Evaluates Diagnostics Sensors in Heart Failure Patients Receiving Boston Scientific's Investigational ICM System.

NCT04790344

Active Not RecruitingNA

Sponsor: Boston Scientific Corporation

Conditions: Heart Failure

Interventions: Investigational LUX-Dx ICM Implant

Countries: United States

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

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

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.

Locations (57)

Birmingham, Alabama, United States
Mobile, Alabama, United States
Jonesboro, Arkansas, United States
Concord, California, United States
La Jolla, California, United States
Loma Linda, California, United States
Los Angeles, California, United States
Orange, California, United States
San Diego, California, United States
Ventura, California, United States
Gainesville, Florida, United States
Gainesville, Florida, United States
Jacksonville, Florida, United States
Lady Lake, Florida, United States
Naples, Florida, United States
Sarasota, Florida, United States
Augusta, Georgia, United States
Augusta, Georgia, United States
Gainesville, Georgia, United States
Gainesville, Georgia, United States
Boise, Idaho, United States
Chicago, Illinois, United States
Downers Grove, Illinois, United States
Indianapolis, Indiana, United States
Indianapolis, Indiana, United States
Kansas City, Kansas, United States
Lexington, Kentucky, United States
Maplewood, Minnesota, United States
Minneapolis, Minnesota, United States
Jackson, Mississippi, United States
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