LUX-Dx TRENDS Evaluates Diagnostics Sensors in Heart Failure Patients Receiving Boston Scientific's Investigational ICM System.
Не е приложима фаза (напр. обсервационно)
Заболявания:
Heart Failure
Спонсор: Boston Scientific Corporation
Налично на:
БГ
Обобщение
The primary objective of this study is to collect sensor data from insertable cardiac monitor systems.
Описание
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.
Кой може да участва
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.
Интервенции
Investigational LUX-Dx ICM Implant
DEVICE
Места на провеждане
56
САЩ (56)
Capital Cardiology Associates, PC
Albany , New York
Lehigh Valley Hospital
Allentown , Pennsylvania
Piedmont Augusta Hospital
Augusta , Georgia
Augusta University
Augusta , Georgia
Grandview Medical Center - Affinity Hospital, LLC
Birmingham , Alabama
St. Luke's Idaho Cardiology Associates
Boise , Idaho
New York Methodist Hospital
Brooklyn , New York
Ralph H. Johnson Department of Veterans Affairs Medical Center
Charleston , South Carolina
Sanger Heart and Vascular Institute
Charlotte , North Carolina
Northwestern University
Chicago , Illinois
John Muir Medical Center
Concord , California
Advocate Good Samaritan Hospital
Downers Grove , Illinois
The Cardiac and Vascular Institute
Gainesville , Florida
North Florida South Georgia VA
Gainesville , Florida
Northside Hospital
Gainesville , Georgia
Northeast Georgia Heart Center, Inc.
Gainesville , Georgia
University of Texas Medical Branch
Galveston , Texas
Medication Management
Greensboro , North Carolina
Penn State Health Milton S. Hershey Medical Center
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