Heart FailureNCT04790344
LUX-Dx TRENDS Evaluates Diagnostics Sensors in Heart Failure Patients Receiving Boston Scientific's Investigational ICM System.
A study testing Investigational LUX-Dx ICM Implant in people with Heart Failure, run by Boston Scientific Corporation at 57 sites in United States.
Trial summary
The primary objective of this study is to collect sensor data from insertable cardiac monitor systems. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Investigational LUX-Dx ICM Implant
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 557 participants
- Where
- 57 sitesUnited States
- Study dates
- 20 Mar 2021to 27 Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
57 sites in 1 country.
57 sites in 1 country
United States57 sites
Capital Cardiology Associates, PC
Albany, New York, 12211
Lehigh Valley Hospital
Allentown, Pennsylvania, 18103
Piedmont Augusta Hospital
Augusta, Georgia, 30901
Augusta University
Augusta, Georgia, 30912
Grandview Medical Center - Affinity Hospital, LLC
Birmingham, Alabama, 35243
St. Luke's Idaho Cardiology Associates
Boise, Idaho, 83712
New York Methodist Hospital
Brooklyn, New York, 11215
Ralph H. Johnson Department of Veterans Affairs Medical Center
Charleston, South Carolina, 29401
Sanger Heart and Vascular Institute
Charlotte, North Carolina, 28204
Northwestern University
Chicago, Illinois, 60611
John Muir Medical Center
Concord, California, 94520
Advocate Good Samaritan Hospital
Downers Grove, Illinois, 60515
The Cardiac and Vascular Institute
Gainesville, Florida, 32605
North Florida South Georgia VA
Gainesville, Florida, 32608
Northside Hospital
Gainesville, Georgia, 30342
Northeast Georgia Heart Center, Inc.
Gainesville, Georgia, 30501
University of Texas Medical Branch
Galveston, Texas, 77555
Medication Management
Greensboro, North Carolina, 27408
Penn State Health Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033
Marshall Cardiology
Huntington, West Virginia, 25701
Franciscan Physician Network-Indiana Heart Physicians
Indianapolis, Indiana, 46237
Community Heart and Vascular Hospital
Indianapolis, Indiana, 46250
University of Mississippi Medical Center
Jackson, Mississippi, 39219
St. John's Center for Clinical Research (First Coast Heart and Vascular Center, PLLC)
Jacksonville, Florida, 32216
Arrhythmia Research Group
Jonesboro, Arkansas, 72401
University of Kansas Hospital
Kansas City, Kansas, 66160
Saint Luke's Hospital of Kansas City
Kansas City, Missouri, 64111
Scripps Memorial Hospital
La Jolla, California, 92037
Village Heart and Vein Center
Lady Lake, Florida, 32159
Baptist Health Lexington
Lexington, Kentucky, 40503
VA Loma Linda
Loma Linda, California, 92357
Kaiser Permanenty Los Angeles Medical Center
Los Angeles, California, 90027
M Health Fairview St. John's Hospital
Maplewood, Minnesota, 55109
Minneapolis VA
Minneapolis, Minnesota, 55417
Mobile Infirmary
Mobile, Alabama, 36608
Naples Heart and Rhythm
Naples, Florida, 34119
St. Thomas Research Institute
Nashville, Tennessee, 37205
Columbia University Medical Center/NYPH
New York, New York, 10032
The New York Hospital Medical Center of Queens
New York, New York, 11355
University of California - Irvine
Orange, California, 92868
Orion Medical
Pasadena, Texas, 77505
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107
University of Pittsburgh Medical Center Presbyterian Hospital
Pittsburgh, Pennsylvania, 15213
Cardiovascular Research of Knoxville
Powell, Tennessee, 37849
WakeMed
Raleigh, North Carolina, 27610
San Diego Cardiac Center
San Diego, California, 92123
Sarasota Memorial Hospital
Sarasota, Florida, 34239
VA Puget Sound Healthcare System
Seattle, Washington, 98108
Cardiovascular Associates of the Delaware Valley
Sewell, New Jersey, 08080
Providence Sacred Heart Medical Center
Spokane, Washington, 99204
Sacred Heart Medical Center at Riverbend
Springfield, Oregon, 97477
Saint Louis University Hospital
St Louis, Missouri, 63110
Cardiology Associates Research, LLC/North Mississippi Medical Center
Tupelo, Mississippi, 38801
PeaceHealth Southwest
Vancouver, Washington, 98664
Cardiology Associates Medical Group
Ventura, California, 55109
Wake Forest University School of Medicine
Winston-Salem, North Carolina, 27157
Wellspan York Hospital
York, Pennsylvania, 17403
About this study
Official title: LUX-Dx Heart Failure Sensors in an Insertable Cardiac Monitor System Clinical Study (LUX-Dx TRENDS)
The primary objective of this study is to collect sensor data from insertable cardiac monitor systems.
Read the detailed 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.
- Conditions
- Heart Failure
- Being tested
- Investigational LUX-Dx ICM Implant
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Investigational LUX-Dx ICM ImplantDevice
All subject will receive an investigational version of the LUX-Dx ICM device.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm | Experimental | All study subjects belong to Treatment Arm, which is receiving investigational LUX-Dx ICM device. Receives: Device: Investigational LUX-Dx ICM Implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.).
Measured: Through study completion of approximately 4.5 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2021
- Study start20 Mar 2021
- Primary completion27 Jul 2026
- Study completion27 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Boston Scientific CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 557 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Scott Solomon, MD, Principal investigator, Brigham and Women's HospitalElaine Wan, MD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04790344
- Sponsor's protocol ID
- C2118
- Status last verified
- Oct 2026
- First submitted
- 4 Mar 2021
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LUX-Dx Heart Failure Sensors in an Insertable Cardiac Monitor System Clinical Study (LUX-Dx TRENDS)
- ClinicalTrials.gov ID
- NCT04790344
- Acronym / sponsor ID
- C2118
- Conditions
- Heart Failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 557 participants (actual)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Study start
- 20 Mar 2021 (actual)
- Primary completion
- 27 Jul 2026 (actual)
- Study completion
- 27 Jul 2026 (actual)
- First posted
- 10 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to collect sensor data from insertable cardiac monitor systems.
Detailed 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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm | Experimental | Device: Investigational LUX-Dx ICM ImplantAll study subjects belong to Treatment Arm, which is receiving investigational LUX-Dx ICM device. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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:
- 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:
- 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 (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Investigational LUX-Dx ICM ImplantAll subject will receive an investigational version of the LUX-Dx ICM device. | Device | Treatment Arm |
Primary outcome
Heart Failure Event Related Data will be assessed in all subjects through collection of reportable events and subsequent adjudication by the CEC.
Time frame: Through study completion of approximately 4.5 year
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.).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for Heart Failure
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
Not yet recruitingPhase 2
A Study of Bimagrumab in Participants With HFpEF
Heart Failure, Diastolic, Diastolic Heart Failure
Recruiting
Evaluation of a French Hospital Discharge Therapeutic Education Program by Nurses for Heart Failure Patient (EduSor)
Heart Failure
Active, not recruiting
Assessment of Combined CCM and ICD Device in HFrEF
Heart Failure, Heart Failure With Reduced Ejection Fraction
Not yet recruiting
RELIEVE-HFrEF TRIAL: REducing Lung congestIon Symptoms Using the v-wavE Shunt in adVancEd Heart Failure With Reduced EF
Heart Failure and Reduced Ejection Fraction, Heart Failure Chronic
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Scott Solomon, MD principal investigator
Brigham and Women's Hospital
Elaine Wan, MD principal investigator
Columbia University
57 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Investigational LUX-Dx ICM Implant in people with Heart Failure, run by Boston Scientific Corporation at 57 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 57 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heart Failure Event Related Data will be assessed in all subjects through collection of reportable events and subsequent adjudication by the CEC. (time frame: Through study completion of approximately 4.5 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2026.