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

Heart Failure Clinical Trial

Official title:

LUX-Dx Heart Failure Sensors in an Insertable Cardiac Monitor System Clinical Study (LUX-Dx TRENDS)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04790344
• Other study ID #: C2118
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 20, 2021
• Est. completion date: June 2026

Study information

• Verified date: June 2024
• Source: Boston Scientific Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 525
• Est. completion date: June 2026
• Est. primary completion date: May 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Heart Failure

Intervention

Device:
• Investigational LUX-Dx ICM Implant
All subject will receive an investigational version of the LUX-Dx ICM device.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Boston Scientific Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Heart Failure Event Related Data will be assessed in all subjects through collection of reportable events and subsequent adjudication by the CEC.	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.).	Through study completion of approximately 4.5 year