LUX-Dx TRENDS Evaluates Diagnostics Sensors in Heart Failure Patients Receiving Boston Scientific's Investigational ICM System.
- Conditions
- Heart Failure
- Interventions
- Device: Investigational LUX-Dx ICM Implant
- Registration Number
- NCT04790344
- Lead Sponsor
- Boston Scientific Corporation
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 525
-
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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Treatment Arm Investigational LUX-Dx ICM Implant All study subjects belong to Treatment Arm, which is receiving investigational LUX-Dx ICM device.
- Primary Outcome Measures
Name Time Method Heart Failure Event Related Data will be assessed in all subjects through collection of reportable events and subsequent adjudication by the CEC. Through study completion of approximately 4.5 year Heart Failure (HF) event is defined as:
* HF Hospitalization: subject is admitted with a calendar date change with signs/symptoms of congestive heart failure (CHF) and receives unscheduled augmented HF therapy with oral or intravenous medications, ultrafiltration therapy or other parenteral therapy.
* HF Outpatient Visit: subject has signs/symptoms of CHF, and receives unscheduled intravenous decongestive therapy in a setting that does not involve a hospitalization with a calendar date change (e.g.: ER visit, HF clinic, primary care clinic, etc.).
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (56)
Grandview Medical Center - Affinity Hospital, LLC
🇺🇸Birmingham, Alabama, United States
Mobile Infirmary
🇺🇸Mobile, Alabama, United States
Arrhythmia Research Group
🇺🇸Jonesboro, Arkansas, United States
John Muir Medical Center
🇺🇸Concord, California, United States
Scripps Memorial Hospital
🇺🇸La Jolla, California, United States
VA Loma Linda
🇺🇸Loma Linda, California, United States
Kaiser Permanenty Los Angeles Medical Center
🇺🇸Los Angeles, California, United States
University of California - Irvine
🇺🇸Orange, California, United States
San Diego Cardiac Center
🇺🇸San Diego, California, United States
Cardiology Associates Medical Group
🇺🇸Ventura, California, United States
The Cardiac and Vascular Institute
🇺🇸Gainesville, Florida, United States
North Florida South Georgia VA
🇺🇸Gainesville, Florida, United States
St. John's Center for Clinical Research (First Coast Heart and Vascular Center, PLLC)
🇺🇸Jacksonville, Florida, United States
Village Heart and Vein Center
🇺🇸Lady Lake, Florida, United States
Naples Heart and Rhythm
🇺🇸Naples, Florida, United States
Sarasota Memorial Hospital
🇺🇸Sarasota, Florida, United States
Piedmont Augusta Hospital
🇺🇸Augusta, Georgia, United States
Augusta University
🇺🇸Augusta, Georgia, United States
Northside Hospital
🇺🇸Gainesville, Georgia, United States
Northeast Georgia Heart Center, Inc.
🇺🇸Gainesville, Georgia, United States
St. Luke's Idaho Cardiology Associates
🇺🇸Boise, Idaho, United States
Northwestern University
🇺🇸Chicago, Illinois, United States
Advocate Good Samaritan Hospital
🇺🇸Downers Grove, Illinois, United States
Franciscan Physician Network-Indiana Heart Physicians
🇺🇸Indianapolis, Indiana, United States
Community Heart and Vascular Hospital
🇺🇸Indianapolis, Indiana, United States
University of Kansas Hospital
🇺🇸Kansas City, Kansas, United States
Baptist Health Lexington
🇺🇸Lexington, Kentucky, United States
M Health Fairview St. John's Hospital
🇺🇸Maplewood, Minnesota, United States
Minneapolis VA
🇺🇸Minneapolis, Minnesota, United States
University of Mississippi Medical Center
🇺🇸Jackson, Mississippi, United States
Cardiology Associates Research, LLC/North Mississippi Medical Center
🇺🇸Tupelo, Mississippi, United States
Saint Luke's Hospital of Kansas City
🇺🇸Kansas City, Missouri, United States
Saint Louis University Hospital
🇺🇸Saint Louis, Missouri, United States
Cardiovascular Associates of the Delaware Valley
🇺🇸Sewell, New Jersey, United States
Capital Cardiology Associates, PC
🇺🇸Albany, New York, United States
New York Methodist Hospital
🇺🇸Brooklyn, New York, United States
Columbia University Medical Center/NYPH
🇺🇸New York, New York, United States
The New York Hospital Medical Center of Queens
🇺🇸New York, New York, United States
Sanger Heart and Vascular Institute
🇺🇸Charlotte, North Carolina, United States
Medication Management
🇺🇸Greensboro, North Carolina, United States
WakeMed
🇺🇸Raleigh, North Carolina, United States
Wake Forest University School of Medicine
🇺🇸Winston-Salem, North Carolina, United States
Sacred Heart Medical Center at Riverbend
🇺🇸Springfield, Oregon, United States
Lehigh Valley Hospital
🇺🇸Allentown, Pennsylvania, United States
Penn State Health Milton S. Hershey Medical Center
🇺🇸Hershey, Pennsylvania, United States
Thomas Jefferson University Hospital
🇺🇸Philadelphia, Pennsylvania, United States
University of Pittsburgh Medical Center Presbyterian Hospital
🇺🇸Pittsburgh, Pennsylvania, United States
Wellspan York Hospital
🇺🇸York, Pennsylvania, United States
Ralph H. Johnson Department of Veterans Affairs Medical Center
🇺🇸Charleston, South Carolina, United States
St. Thomas Research Institute
🇺🇸Nashville, Tennessee, United States
Cardiovascular Research of Knoxville
🇺🇸Powell, Tennessee, United States
University of Texas Medical Branch
🇺🇸Galveston, Texas, United States
Orion Medical
🇺🇸Pasadena, Texas, United States
VA Puget Sound Healthcare System
🇺🇸Seattle, Washington, United States
PeaceHealth Southwest
🇺🇸Vancouver, Washington, United States
Marshall Cardiology
🇺🇸Huntington, West Virginia, United States