Heart Failure Clinical Trial

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

Summary

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

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Full 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.

View Eligibility Criteria

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.

Study is for people with:

Heart Failure

Estimated Enrollment:

525

Study ID:

NCT04790344

Recruitment Status:

Active, not recruiting

Sponsor:

Boston Scientific Corporation

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There are 61 Locations for this study

See Locations Near You

Grandview Medical Center - Affinity Hospital, LLC
Birmingham Alabama, 35243, United States
Mobile Infirmary
Mobile Alabama, 36608, United States
Arrhythmia Research Group
Jonesboro Arkansas, 72401, United States
John Muir Medical Center
Concord California, 94520, United States
Scripps Memorial Hospital
La Jolla California, 92037, United States
VA Loma Linda
Loma Linda California, 92357, United States
Kaiser Permanenty Los Angeles Medical Center
Los Angeles California, 90027, United States
University of California - Irvine
Orange California, 92868, United States
San Diego Cardiac Center
San Diego California, 92123, United States
Cardiology Associates Medical Group
Ventura California, 55109, United States
The Cardiac and Vascular Institute
Gainesville Florida, 32605, United States
North Florida South Georgia VA
Gainesville Florida, 32608, United States
St. John's Center for Clinical Research (First Coast Heart and Vascular Center, PLLC)
Jacksonville Florida, 32216, United States
Village Heart and Vein Center
Lady Lake Florida, 32159, United States
Naples Heart and Rhythm
Naples Florida, 34119, United States
Orlando Regional Medical Center
Orlando Florida, 32806, United States
Sarasota Memorial Hospital
Sarasota Florida, 34239, United States
Piedmont Augusta Hospital
Augusta Georgia, 30901, United States
Augusta University
Augusta Georgia, 30912, United States
Northside Hospital
Gainesville Georgia, 30342, United States
Northeast Georgia Heart Center, Inc.
Gainesville Georgia, 30501, United States
St. Luke's Idaho Cardiology Associates
Boise Idaho, 83712, United States
Northwestern University
Chicago Illinois, 60611, United States
Advocate Good Samaritan Hospital
Downers Grove Illinois, 60515, United States
Franciscan Physician Network-Indiana Heart Physicians
Indianapolis Indiana, 46237, United States
Community Heart and Vascular Hospital
Indianapolis Indiana, 46250, United States
University of Iowa Hospitals and Clinics
Iowa City Iowa, 52242, United States
University of Kansas Hospital
Kansas City Kansas, 66160, United States
Baptist Health Lexington
Lexington Kentucky, 40503, United States
Tulane University Heart and Vascular Institute
New Orleans Louisiana, 70112, United States
Brigham and Women's Hospital
Boston Massachusetts, 02115, United States
M Health Fairview St. John's Hospital
Maplewood Minnesota, 55109, United States
Minneapolis VA
Minneapolis Minnesota, 55417, United States
University of Mississippi Medical Center
Jackson Mississippi, 39219, United States
Cardiology Associates Research, LLC/North Mississippi Medical Center
Tupelo Mississippi, 38801, United States
Saint Luke's Hospital of Kansas City
Kansas City Missouri, 64111, United States
Saint Louis University Hospital
Saint Louis Missouri, 63110, United States
New Jersey Medical School, University of Medicine & Dentistry of New Jersey
Newark New Jersey, 07103, United States
Cardiovascular Associates of the Delaware Valley
Sewell New Jersey, 08080, United States
Capital Cardiology Associates, PC
Albany New York, 12211, United States
New York Methodist Hospital
Brooklyn New York, 11215, United States
Columbia University Medical Center/NYPH
New York New York, 10032, United States
The New York Hospital Medical Center of Queens
New York New York, 11355, United States
Sanger Heart and Vascular Institute
Charlotte North Carolina, 28204, United States
Medication Management
Greensboro North Carolina, 27408, United States
WakeMed
Raleigh North Carolina, 27610, United States
Wake Forest University School of Medicine
Winston-Salem North Carolina, 27157, United States
Sacred Heart Medical Center at Riverbend
Springfield Oregon, 97477, United States
Lehigh Valley Hospital
Allentown Pennsylvania, 18103, United States
Penn State Health Milton S. Hershey Medical Center
Hershey Pennsylvania, 17033, United States
Thomas Jefferson University Hospital
Philadelphia Pennsylvania, 19107, United States
University of Pittsburgh Medical Center Presbyterian Hospital
Pittsburgh Pennsylvania, 15213, United States
Wellspan York Hospital
York Pennsylvania, 17403, United States
Ralph H. Johnson Department of Veterans Affairs Medical Center
Charleston South Carolina, 29401, United States
St. Thomas Research Institute
Nashville Tennessee, 37205, United States
Vanderbilt University Medical Center
Nashville Tennessee, 37232, United States
Cardiovascular Research of Knoxville
Powell Tennessee, 37849, United States
University of Texas Medical Branch
Galveston Texas, 77555, United States
Orion Medical
Pasadena Texas, 77505, United States
VA Puget Sound Healthcare System
Seattle Washington, 98108, United States
PeaceHealth Southwest
Vancouver Washington, 98664, United States
Marshall Cardiology
Huntington West Virginia, 25701, United States

How clear is this clinincal trial information?

Study is for people with:

Heart Failure

Estimated Enrollment:

525

Study ID:

NCT04790344

Recruitment Status:

Active, not recruiting

Sponsor:


Boston Scientific Corporation

How clear is this clinincal trial information?

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