Phase
Condition
Heart Failure
Chest Pain
Congestive Heart Failure
Treatment
Investigational LUX-Dx ICM Implant
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Key Inclusion Criteria:
Patient is currently in NYHA Class II or III.
For patients with LVEF >40% measured on most recent available echocardiographywithin the previous 12 months:
ONE (1) of the following echocardiography findings: LA width (diameter) >3.8cm, LA length >5.0 cm, LA area >20 cm2, LA volume >55 ml, LA volume index >29ml/m2, LVH defined by septal thickness or posterior wall thickness of >1.1 cmAND
ONE (1) of the following: Elevated BNP/NT-proBNP as defined by: BNP >100 pg/mlor NT-proBNP >300 pg/ml within the previous 90 days for patients not in atrialfibrillation or BNP >300 pg/ml or NT-proBNP >900 pg/ml for patients in atrialfibrillation at the time of screening for eligibility OR Documented heartfailure 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/mlor NT-proBNP >600 pg/ml within the previous 90 days for patients not in atrialfibrillation or BNP >450 pg/ml or NT-proBNP >1800 pg/ml for patients in atrialfibrillation at the time of screening for eligibility OR Documented heartfailure 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 patientmobile app.
Patient is of legal age to give informed consent and is willing to participate inthe trial.
Exclusion
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 (excludingregistries) without prior written approval from Boston Scientific.
Patient is known to be pregnant at the time of enrollment or plans to becomepregnant during study participation.
Patient is diagnosed with amyloidosis or hypertrophic cardiomyopathy.
Study Design
Study Description
Connect with a study center
Grandview Medical Center - Affinity Hospital, LLC
Birmingham, Alabama 35243
United StatesSite Not Available
University of Alabama at Birmingham
Birmingham, Alabama 35294
United StatesSite Not Available
Mobile Infirmary
Mobile, Alabama 36608
United StatesSite Not Available
Grandview Medical Center - Affinity Hospital, LLC
Birmingham 4049979, Alabama 4829764 35243
United StatesSite Not Available
Mobile Infirmary
Mobile 4076598, Alabama 4829764 36608
United StatesSite Not Available
Southwest Cardiovascular Associates
Mesa, Arizona 85208
United StatesSite Not Available
Arrhythmia Research Group
Jonesboro, Arkansas 72401
United StatesSite Not Available
Arrhythmia Research Group
Jonesboro 4116834, Arkansas 4099753 72401
United StatesSite Not Available
John Muir Medical Center
Concord, California 94520
United StatesSite Not Available
Scripps Memorial Hospital
La Jolla, California 92037
United StatesSite Not Available
VA Loma Linda
Loma Linda, California 92357
United StatesSite Not Available
Kaiser Permanenty Los Angeles Medical Center
Los Angeles, California 90027
United StatesSite Not Available
University of Southern California Hospital
Los Angeles, California 90033
United StatesSite Not Available
University of California - Irvine
Orange, California 92868
United StatesSite Not Available
San Diego Cardiac Center
San Diego, California 92123
United StatesSite Not Available
Cardiology Associates Medical Group
Ventura, California 55109
United StatesSite Not Available
John Muir Medical Center
Concord 5339111, California 5332921 94520
United StatesSite Not Available
Scripps Memorial Hospital
La Jolla 5363943, California 5332921 92037
United StatesSite Not Available
VA Loma Linda
Loma Linda 5367696, California 5332921 92357
United StatesSite Not Available
Kaiser Permanenty Los Angeles Medical Center
Los Angeles 5368361, California 5332921 90027
United StatesSite Not Available
University of California - Irvine
Orange 5379513, California 5332921 92868
United StatesSite Not Available
San Diego Cardiac Center
San Diego 5391811, California 5332921 92123
United StatesSite Not Available
Cardiology Associates Medical Group
Ventura 5405878, California 5332921 55109
United StatesSite Not Available
University of Colorado Hospital
Aurora, Colorado 80045
United StatesSite Not Available
Memorial Hospital
Colorado Springs, Colorado 80909
United StatesSite Not Available
Holy Cross
Fort Lauderdale, Florida 33308
United StatesSite Not Available
North Florida South Georgia VA
Gainesville, Florida 32608
United StatesSite Not Available
The Cardiac and Vascular Institute
Gainesville, Florida 32605
United StatesSite Not Available
St. John's Center for Clinical Research (First Coast Heart and Vascular Center, PLLC)
Jacksonville, Florida 32216
United StatesSite Not Available
University of Florida Health - Jacksonville
Jacksonville, Florida 32209
United StatesSite Not Available
Village Heart and Vein Center
Lady Lake, Florida 32159
United StatesSite Not Available
Naples Heart and Rhythm
Naples, Florida 34119
United StatesSite Not Available
Orlando Regional Medical Center
Orlando, Florida 32806
United StatesSite Not Available
Peace River Cardiovascular Center
Port Charlotte, Florida 33952
United StatesSite Not Available
Sarasota Memorial Hospital
Sarasota, Florida 34239
United StatesSite Not Available
Tallahassee Research Institute
Tallahassee, Florida 32308
United StatesSite Not Available
Advent Health - Tampa
Tampa, Florida 33613
United StatesSite Not Available
North Florida South Georgia VA
Gainesville 4156404, Florida 4155751 32608
United StatesSite Not Available
The Cardiac and Vascular Institute
Gainesville 4156404, Florida 4155751 32605
United StatesSite Not Available
St. John's Center for Clinical Research (First Coast Heart and Vascular Center, PLLC)
Jacksonville 4160021, Florida 4155751 32216
United StatesSite Not Available
Village Heart and Vein Center
Lady Lake 4161118, Florida 4155751 32159
United StatesSite Not Available
Naples Heart and Rhythm
Naples 4165565, Florida 4155751 34119
United StatesSite Not Available
Sarasota Memorial Hospital
Sarasota 4172131, Florida 4155751 34239
United StatesSite Not Available
Augusta University
Augusta, Georgia 30912
United StatesSite Not Available
Piedmont Augusta Hospital
Augusta, Georgia 30901
United StatesSite Not Available
University Hospital
Augusta, Georgia 30901
United StatesActive - Recruiting
Northeast Georgia Heart Center, Inc.
Gainesville, Georgia 30501
United StatesSite Not Available
Northside Hospital
Gainesville, Georgia 30342
United StatesSite Not Available
Coliseum Medical Center
Macon, Georgia 31201
United StatesSite Not Available
Augusta University
Augusta 4180531, Georgia 4197000 30912
United StatesSite Not Available
Piedmont Augusta Hospital
Augusta 4180531, Georgia 4197000 30901
United StatesSite Not Available
Northeast Georgia Heart Center, Inc.
Gainesville 4196586, Georgia 4197000 30501
United StatesSite Not Available
Northside Hospital
Gainesville 4196586, Georgia 4197000 30342
United StatesSite Not Available
Queen's Medical Center
Honolulu, Hawaii 96817
United StatesSite Not Available
St. Luke's Idaho Cardiology Associates
Boise, Idaho 83712
United StatesSite Not Available
St. Luke's Idaho Cardiology Associates
Boise 5586437, Idaho 5596512 83712
United StatesSite Not Available
Northwestern University
Chicago, Illinois 60611
United StatesSite Not Available
The University of Chicago
Chicago, Illinois 60637
United StatesSite Not Available
Advocate Good Samaritan Hospital
Downers Grove, Illinois 60515
United StatesSite Not Available
Northwestern University
Chicago 4887398, Illinois 4896861 60611
United StatesSite Not Available
Advocate Good Samaritan Hospital
Downers Grove 4890119, Illinois 4896861 60515
United StatesSite Not Available
Community Heart and Vascular Hospital
Indianapolis, Indiana 46250
United StatesSite Not Available
Franciscan Physician Network-Indiana Heart Physicians
Indianapolis, Indiana 46237
United StatesSite Not Available
Community Heart and Vascular Hospital
Indianapolis 4259418, Indiana 4921868 46250
United StatesSite Not Available
Franciscan Physician Network-Indiana Heart Physicians
Indianapolis 4259418, Indiana 4921868 46237
United StatesSite Not Available
University of Iowa Hospitals and Clinics
Iowa City, Iowa 52242
United StatesSite Not Available
University of Kansas Hospital
Kansas City, Kansas 66160
United StatesSite Not Available
University of Kansas Hospital
Kansas City 4273837, Kansas 4273857 66160
United StatesSite Not Available
Baptist Health Lexington
Lexington, Kentucky 40503
United StatesSite Not Available
Baptist Health East Louisville
Louisville, Kentucky 40207
United StatesSite Not Available
Baptist Health Lexington
Lexington 4297983, Kentucky 6254925 40503
United StatesSite Not Available
Willis Knighton Bossier Medical Center (Grace Research, LLC)
Bossier City, Louisiana 71111
United StatesSite Not Available
Tulane University Heart and Vascular Institute
New Orleans, Louisiana 70112
United StatesSite Not Available
Boston Medical Center
Boston, Massachusetts 02118
United StatesSite Not Available
Brigham and Women's Hospital
Boston, Massachusetts 02115
United StatesSite Not Available
Spectrum Health Hospital
Grand Rapids, Michigan 49503
United StatesSite Not Available
M Health Fairview St. John's Hospital
Maplewood, Minnesota 55109
United StatesSite Not Available
Minneapolis VA
Minneapolis, Minnesota 55417
United StatesSite Not Available
M Health Fairview St. John's Hospital
Maplewood 5036588, Minnesota 5037779 55109
United StatesSite Not Available
Minneapolis VA
Minneapolis 5037649, Minnesota 5037779 55417
United StatesSite Not Available
University of Mississippi Medical Center
Jackson, Mississippi 39219
United StatesSite Not Available
Cardiology Associates Research, LLC/North Mississippi Medical Center
Tupelo, Mississippi 38801
United StatesSite Not Available
University of Mississippi Medical Center
Jackson 4431410, Mississippi 4436296 39219
United StatesSite Not Available
Cardiology Associates Research, LLC/North Mississippi Medical Center
Tupelo 4448903, Mississippi 4436296 38801
United StatesSite Not Available
Saint Luke's Hospital of Kansas City
Kansas City, Missouri 64111
United StatesSite Not Available
Saint Louis University Hospital
Saint Louis, Missouri 63110
United StatesSite Not Available
Saint Louis University Hospital
St Louis, Missouri 63110
United StatesSite Not Available
Saint Louis University Hospital
St. Louis, Missouri 63110
United StatesSite Not Available
Saint Luke's Hospital of Kansas City
Kansas City 4393217, Missouri 4398678 64111
United StatesSite Not Available
Saint Louis University Hospital
St Louis 4407066, Missouri 4398678 63110
United StatesSite Not Available
Dartmouth Hitchock Medical Center
Lebanon, New Hampshire 03766
United StatesSite Not Available
New Jersey Medical School, University of Medicine & Dentistry of New Jersey
Newark, New Jersey 07103
United StatesSite Not Available
Cardiovascular Associates of Delaware Valley
Sewell, New Jersey 08080
United StatesSite Not Available
Cardiovascular Associates of the Delaware Valley
Sewell, New Jersey 08080
United StatesSite Not Available
Cardiovascular Associates of the Delaware Valley
Sewell 4504048, New Jersey 5101760 08080
United StatesSite Not Available
Capital Cardiology Associates, PC
Albany, New York 12211
United StatesSite Not Available
New York Methodist Hospital
Brooklyn, New York 11215
United StatesSite Not Available
Columbia University Medical Center/NYPH
New York, New York 10032
United StatesSite Not Available
The New York Hospital Medical Center of Queens
New York, New York 11355
United StatesSite Not Available
Capital Cardiology Associates, PC
Albany 5106834, New York 5128638 12211
United StatesSite Not Available
New York Methodist Hospital
Brooklyn 5110302, New York 5128638 11215
United StatesSite Not Available
Columbia University Medical Center/NYPH
New York 5128581, New York 5128638 10032
United StatesSite Not Available
The New York Hospital Medical Center of Queens
New York 5128581, New York 5128638 11355
United StatesSite Not Available
Sanger Heart and Vascular Institute
Charlotte, North Carolina 28204
United StatesSite Not Available
Medication Management
Greensboro, North Carolina 27408
United StatesSite Not Available
ECU Health Medical Center/Pitt County Memorial Hospital
Greenville, North Carolina 27834
United StatesSite Not Available
WakeMed
Raleigh, North Carolina 27610
United StatesSite Not Available
Wake Forest University School of Medicine
Winston-Salem, North Carolina 27157
United StatesSite Not Available
Sanger Heart and Vascular Institute
Charlotte 4460243, North Carolina 4482348 28204
United StatesSite Not Available
Medication Management
Greensboro 4469146, North Carolina 4482348 27408
United StatesSite Not Available
WakeMed
Raleigh 4487042, North Carolina 4482348 27610
United StatesSite Not Available
Wake Forest University School of Medicine
Winston-Salem 4499612, North Carolina 4482348 27157
United StatesSite Not Available
The Ohio State University Medical Center
Columbus, Ohio 43210
United StatesSite Not Available
Sacred Heart Medical Center at Riverbend
Springfield, Oregon 97477
United StatesSite Not Available
Sacred Heart Medical Center at Riverbend
Springfield 5754005, Oregon 5744337 97477
United StatesSite Not Available
Lehigh Valley Hospital
Allentown, Pennsylvania 18103
United StatesSite Not Available
Penn State Health Milton S. Hershey Medical Center
Hershey, Pennsylvania 17033
United StatesSite Not Available
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania 19107
United StatesSite Not Available
University of Pittsburgh Medical Center Presbyterian Hospital
Pittsburgh, Pennsylvania 15213
United StatesSite Not Available
Wellspan York Hospital
York, Pennsylvania 17403
United StatesSite Not Available
Lehigh Valley Hospital
Allentown 5178127, Pennsylvania 6254927 18103
United StatesSite Not Available
Penn State Health Milton S. Hershey Medical Center
Hershey 5193342, Pennsylvania 6254927 17033
United StatesSite Not Available
Thomas Jefferson University Hospital
Philadelphia 4560349, Pennsylvania 6254927 19107
United StatesSite Not Available
University of Pittsburgh Medical Center Presbyterian Hospital
Pittsburgh 5206379, Pennsylvania 6254927 15213
United StatesSite Not Available
Wellspan York Hospital
York 4562407, Pennsylvania 6254927 17403
United StatesSite Not Available
Ralph H. Johnson Department of Veterans Affairs Medical Center
Charleston, South Carolina 29401
United StatesSite Not Available
Prisma Health - Upstate
Greenville, South Carolina 29605
United StatesSite Not Available
Ralph H. Johnson Department of Veterans Affairs Medical Center
Charleston 4574324, South Carolina 4597040 29401
United StatesSite Not Available
Erlanger Medical Center
Chattanooga, Tennessee 37403
United StatesSite Not Available
St. Thomas Research Institute
Nashville, Tennessee 37205
United StatesSite Not Available
Vanderbilt University Medical Center
Nashville, Tennessee 37232
United StatesSite Not Available
Cardiovascular Research of Knoxville
Powell, Tennessee 37849
United StatesSite Not Available
St. Thomas Research Institute
Nashville 4644585, Tennessee 4662168 37205
United StatesSite Not Available
Cardiovascular Research of Knoxville
Powell 4651138, Tennessee 4662168 37849
United StatesSite Not Available
University of Texas Medical Branch
Galveston, Texas 77555
United StatesSite Not Available
Orion Medical
Pasadena, Texas 77505
United StatesSite Not Available
University of Texas Medical Branch
Galveston 4692883, Texas 4736286 77555
United StatesSite Not Available
Orion Medical
Pasadena 4717782, Texas 4736286 77505
United StatesSite Not Available
University of Utah Health
Salt Lake City, Utah 84132
United StatesSite Not Available
VA Puget Sound Healthcare System
Seattle, Washington 98108
United StatesSite Not Available
Virginia Mason Medical Center
Seattle, Washington 98101
United StatesSite Not Available
Providence Sacred Heart Medical Center
Spokane, Washington 99204
United StatesSite Not Available
PeaceHealth Southwest
Vancouver, Washington 98664
United StatesSite Not Available
VA Puget Sound Healthcare System
Seattle 5809844, Washington 5815135 98108
United StatesSite Not Available
PeaceHealth Southwest
Vancouver 5814616, Washington 5815135 98664
United StatesSite Not Available
Marshall Cardiology
Huntington, West Virginia 25701
United StatesSite Not Available
Marshall Cardiology
Huntington 4809537, West Virginia 4826850 25701
United StatesSite Not Available
Mayo Clinic - La Crossee
La Crosse, Wisconsin 54601
United StatesSite Not Available

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