Clinical trial NCT04790344: LUX-Dx TRENDS Evaluates Diagnostics Sensors in Heart Failure Patients Receiving Boston Scientific's Investigational ICM System.
Official title: LUX-Dx Heart Failure Sensors in an Insertable Cardiac Monitor System Clinical Study (LUX-Dx TRENDS)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Heart Failure
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2021-03-10
Enrollment: 525
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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 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.

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.

Primary outcomes:
measure: 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
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Grandview Medical Center - Affinity Hospital, LLC
state: Alabama
city: Mobile
country: United States
facility: Mobile Infirmary
state: Alabama
city: Jonesboro
country: United States
facility: Arrhythmia Research Group
state: Arkansas
city: Concord
country: United States
facility: John Muir Medical Center
state: California
city: La Jolla
country: United States
facility: Scripps Memorial Hospital
state: California
city: Loma Linda
country: United States
facility: VA Loma Linda
state: California
city: Los Angeles
country: United States
facility: Kaiser Permanenty Los Angeles Medical Center
state: California
city: Orange
country: United States
facility: University of California - Irvine
state: California
city: San Diego
country: United States
facility: San Diego Cardiac Center
state: California
city: Ventura
country: United States
facility: Cardiology Associates Medical Group
state: California
city: Gainesville
country: United States
facility: The Cardiac and Vascular Institute
state: Florida
city: Gainesville
country: United States
facility: North Florida South Georgia VA
state: Florida
city: Jacksonville
country: United States
facility: St. John's Center for Clinical Research (First Coast Heart and Vascular Center, PLLC)
state: Florida
city: Lady Lake
country: United States
facility: Village Heart and Vein Center
state: Florida
city: Naples
country: United States
facility: Naples Heart and Rhythm
state: Florida
city: Sarasota
country: United States
facility: Sarasota Memorial Hospital
state: Florida
city: Augusta
country: United States
facility: Piedmont Augusta Hospital
state: Georgia
city: Augusta
country: United States
facility: Augusta University
state: Georgia
city: Gainesville
country: United States
facility: Northside Hospital
state: Georgia
city: Gainesville
country: United States
facility: Northeast Georgia Heart Center, Inc.
state: Georgia
city: Boise
country: United States
facility: St. Luke's Idaho Cardiology Associates
state: Idaho
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Downers Grove
country: United States
facility: Advocate Good Samaritan Hospital
state: Illinois
city: Indianapolis
country: United States
facility: Franciscan Physician Network-Indiana Heart Physicians
state: Indiana
city: Indianapolis
country: United States
facility: Community Heart and Vascular Hospital
state: Indiana
city: Kansas City
country: United States
facility: University of Kansas Hospital
state: Kansas
city: Lexington
country: United States
facility: Baptist Health Lexington
state: Kentucky
city: Maplewood
country: United States
facility: M Health Fairview St. John's Hospital
state: Minnesota
city: Minneapolis
country: United States
facility: Minneapolis VA
state: Minnesota
city: Jackson
country: United States
facility: University of Mississippi Medical Center
state: Mississippi
city: Tupelo
country: United States
facility: Cardiology Associates Research, LLC/North Mississippi Medical Center
state: Mississippi
city: Kansas City
country: United States
facility: Saint Luke's Hospital of Kansas City
state: Missouri
city: Saint Louis
country: United States
facility: Saint Louis University Hospital
state: Missouri
city: Sewell
country: United States
facility: Cardiovascular Associates of the Delaware Valley
state: New Jersey
city: Albany
country: United States
facility: Capital Cardiology Associates, PC
state: New York
city: Brooklyn
country: United States
facility: New York Methodist Hospital
state: New York
city: New York
country: United States
facility: Columbia University Medical Center/NYPH
state: New York
city: New York
country: United States
facility: The New York Hospital Medical Center of Queens
state: New York
city: Charlotte
country: United States
facility: Sanger Heart and Vascular Institute
state: North Carolina
city: Greensboro
country: United States
facility: Medication Management
state: North Carolina
city: Raleigh
country: United States
facility: WakeMed
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest University School of Medicine
state: North Carolina
city: Springfield
country: United States
facility: Sacred Heart Medical Center at Riverbend
state: Oregon
city: Allentown
country: United States
facility: Lehigh Valley Hospital
state: Pennsylvania
city: Hershey
country: United States
facility: Penn State Health Milton S. Hershey Medical Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: Thomas Jefferson University Hospital
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center Presbyterian Hospital
state: Pennsylvania
city: York
country: United States
facility: Wellspan York Hospital
state: Pennsylvania
city: Charleston
country: United States
facility: Ralph H. Johnson Department of Veterans Affairs Medical Center
state: South Carolina
city: Nashville
country: United States
facility: St. Thomas Research Institute
state: Tennessee
city: Powell
country: United States
facility: Cardiovascular Research of Knoxville
state: Tennessee
city: Galveston
country: United States
facility: University of Texas Medical Branch
state: Texas
city: Pasadena
country: United States
facility: Orion Medical
state: Texas
city: Seattle
country: United States
facility: VA Puget Sound Healthcare System
state: Washington
city: Vancouver
country: United States
facility: PeaceHealth Southwest
state: Washington
city: Huntington
country: United States
facility: Marshall Cardiology
state: West Virginia
Study officials:
affiliation: Brigham and Women's Hospital
name: Scott Solomon, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Columbia University
name: Elaine Wan, MD
role: PRINCIPAL_INVESTIGATOR
References: