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Study identifier: NCT04790344 Synced from ClinicalTrials.gov · August 08, 2026
● Study status: Active Not Recruiting

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

Condition: Heart Failure  ·  Sponsor: Boston Scientific Corporation

PhaseNA
Planned participants525
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNoCheck eligibility criteria ↓
Where57 locations

Sponsor, CRO or site team? See where this study is running → — listed sites, countries and recruiting context. Everything below is written for patients and caregivers.

About this study

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

This description comes directly from the study's public registry record.

Talk to the study team

No contact information is available for this study as per the public registry record.

Always discuss trial participation with your own doctor first.

Full eligibility criteria (exactly as the study team wrote them)

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.

Reproduced word-for-word from the public registry record — the study team can answer questions about it.

Locations (57)

Grandview Medical Center - Affinity Hospital, LLCBirmingham, Alabama, United States
Mobile InfirmaryMobile, Alabama, United States
Arrhythmia Research GroupJonesboro, Arkansas, United States
John Muir Medical CenterConcord, California, United States
Scripps Memorial HospitalLa Jolla, California, United States
VA Loma LindaLoma Linda, California, United States
Kaiser Permanenty Los Angeles Medical CenterLos Angeles, California, United States
University of California - IrvineOrange, California, United States
San Diego Cardiac CenterSan Diego, California, United States
Cardiology Associates Medical GroupVentura, California, United States
The Cardiac and Vascular InstituteGainesville, Florida, United States
North Florida South Georgia VAGainesville, Florida, United States

+ 45 more locations — full list on the registry record.

More studies in these areas

This study lists sites in the areas below. Each link shows other recruiting studies near that city, from the public registry record.

BirminghamMobileJonesboroConcord

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